2015 Education Brochure

pda.org/courses

Parenteral Drug Association U.S. Education Courses

2015 PDA U.S. Education CoursesWhere Excellence Begins

Laboratory and Classroom Training for Pharmaceutical and Biopharmaceutical ProfessionalsM A R C H – D E C E M B E R 2 0 1 5

2015 PDA U.S. Education CoursesCheck pda.org/calendar for an updated list of courses

Denotes Laboratory Courses Denotes

DATES COURSE NAME LOCATION TYPE

1/26 – 1/30 2/23 – 2/27 Aseptic Processing Training Program, Session 1 | pda.org/2015aseptic1 SOLD OUT Bethesda, MD Lab

3/9 – 3/13 Fundamentals of Aseptic Processing | pda.org/FAP1 Bethesda, MD Lab

3/19 – 3/20 2015 PDA Annual Meeting Course Series | pdannualmeeting.org/courses Las Vegas, NV Lecture

3/19 Technical and Regulatory Challenges of Combination Drug Delivery Products – Pre-filled Syringes, Autoinjectors and Injection Pens

3/19 The Quality Culture and Its Measurement – New Course

3/19 Applying Six Sigma Techniques to the Process Validation Lifecycle – New Course

3/19 – 3/20 Sterile Pharmaceutical Dosage Forms

3/20 Developing a Robust Supplier Management Process


4/20 – 4/23 Train the Trainer Week | pda.org/trainer Bethesda, MD Lecture

4/20 Qualifying Your SMEs as Trainers

4/21 – 4/22 Learning, Knowledge Management and Impact: Moving from Theory to Practice

4/23 Designing/Presenting GXP Training Programs to Meet FDA Requirements

4/27 – 4/29 Validation of Biotechnology-related Cleaning Processes | pda.org/biotechclean Bethesda, MD Lab

5/4 – 5/7 Lyophilization Week | pda.org/lyo Bethesda, MD Lecture5/4 – 5/5 Fundamentals of Lyophilization

5/6 – 5/7 Validation of Lyophilization

5/11 – 5/12 Recommended Practices for Manual Aseptic Processes | pda.org/MAP Bethesda, MD Lab

5/13 Risk Based Approach for Prevention and Management of Drug Shortages | pda.org/prevention Bethesda, MD Lecture


5/20 – 5/21 2015 PDA Pharmaceutical Packaging Course Series | pda.org/packagingcourses Baltimore, MD Lecture5/20 Selection and Utilization of Glass Containers in Pharmaceutical Packaging

5/21 Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Packaging and Labeling of Drug Products

5/22 Technical Development of Prefilled Syringes, Autoinjectors and Injection Pens | pda.org/techdevelop Immediately following the 2015 PDA Drug Delivery Combination Products Workshop

Baltimore, MD Lecture

6/1 – 6/3 Management of Aseptic Processing | pda.org/apmanagement Bethesda, MD Lab

6/4 Process Simulation Testing for Aseptically Filled Products | pda.org/simulation Bethesda, MD Lecture

6/9 – 6/10 Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing Facilities | pda.org/cleaning

Bethesda, MD Lab

6/11 – 6/12 2015 PDA Aseptic Processing – Sterilization Course Series | pda.org/sterilizationcourses San Diego, CA Lecture6/11 Process Simulation Testing for Aseptically Filled Products

6/11 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

6/12 Recommended Practices for Manual Aseptic Processes

6/12 Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat

6/25 – 6/26 2015 PDA Single Use Systems Workshop Course Series | pda.org/suscourses Bethesda, MD

Assessing Packaging and Processing Extractables/Leachables Lab

Single Use Systems for the Manufacturing of Parenteral Products Lecture

7/7 Application of Phase-Appropriate GMP to the Development of Protein Bulk Drug Substances | pda.org/bulkdrug Bethesda, MD Lecture

7/8 A Former Investigator’s Perspective on Conducting Effective Deviation Investigations, Root Cause Investigations and Corrective and Preventive Actions (CAPA) | pda.org/capa Bethesda, MD Lecture

PDA U.S. Education Courses | M A R C H – D E C E M B E R 2 0 1 5

pda.org/courses 3

Fundamentals of Aseptic ProcessingMarch 9 – 13, 2015PDA Training and Research Institute | Bethesda, Maryland

This 5-day laboratory course will provide you with an understanding of the fundamental principles governing aseptic processing, focusing on the systems associated with aseptic processing and how they work together to help ensure a sterile product.

Upon completion of this course, you will be able to:

• Outline the process steps involved in producing aseptically filled products • Describe how different aspects of aseptic processing are interrelated • Identify microorganisms of specific concern in controlled environments and their origins • Discuss your specific role in aseptic processing and how you fit in • Explain the process steps most commonly described as risky, and how you can manage those risks

Instructors:Carol Lampe, Trainer and ConsultantBrent Watkins, Southeast Sales Manager, Veltek Associates Inc.

pda.org/fap1

4 pda.org/courses

Connecting People, Science and Regulation®

2015 PDA Annual Meeting Course Series March 19 – 20, 2015 Red Rock Casino, Resort and Spa | Las Vegas, Nevada

Immediately following the 2015 PDA Annual Meeting, PDA will be offering five courses designed to complement what you’ve learned at the conference.

Technical and Regulatory Challenges of Drug Delivery Combination Products – Prefilled Syringes, Autoinjectors and Injection Pens (March 19)Examine the technical and regulatory challenges companies will face in the development and registration of Drug Delivery Combination Products. Learn to initiate a gap analysis to identify the requirements and elements of a successful Drug Delivery Combination Product development program. Proper implementation of these elements will minimize project risk.

Instructor:Lee Leichter, President, P/L Biomedical

NEW COURSEThe Quality Culture and its Measurement (March 19)This course will provide an opportunity to discuss the components of a quality culture, how to measure those

components and strategies for enacting change. Through a combination of lecture and small group exercises, this course will enable you to evaluate your company culture and come up with ideas on how to improve it.

PrerequisitesParticipants should read ICH Q10 and the article, “The Quality Culture and its Measurement,” by R. Kieffer. Class attendees are asked to bring their thoughts and perspectives on their own company’s culture.

Instructor:Robert G. Kieffer, PhD, President, RGK Consulting

NEW COURSEApplying Six Sigma Techniques to the Process Validation Lifecycle (March 19)Review the fundamental steps in the Six Sigma process, discuss the use of risk assessments in assigning appropriate

sample sizes, and provide case studies in the appropriate data analysis across the lifecycle. The primary focus in this one-day course will be on stage 2b – Process Performance Qualification (PPQ).

Instructor:Mike Long, Director, Consulting Services, ValSource, LLC


pda.org/courses 5

Sterile Pharmaceutical Dosage Forms: Basic Principles (March 19 – 20)This introductory two-day course will address clean room design, environmental monitoring and control, sterilization principles, manufacturing unit operations, aseptic filling, dosage form development, packaging and stability requirements, validation of aseptic processing (media fills), product specific validation, QA/QC for parenterals, and regulatory trends.

Upon completion of this course, you will be able to describe the basic principles of clean room facility design, environmental monitoring, and aseptic processing; summarize the current cGMP regulatory and inspection trends for parenteral manufacturing; and much more!

Instructor: John Ludwig, Senior Vice President, Pfizer

Developing a Robust Supplier Management Process (March 20)Determine appropriate level of control for suppliers based on risk and developing assessment methods and continuous monitoring tools. Through discussion of “best practices” and current regulatory expectations, you will develop a better understanding of supplier selection, evaluation and monitoring processes and will be able to apply these concepts within your own company’s supplier management process. At the conclusion of this course, you will be familiar with current regulatory expectations regarding supplier management and be able to implement these concepts in your own company to reduce the risks associated with supplier management.

Instructor: Lisa Hornback, Principal Consultant, Hornback Consulting, LLC

pdaannualmeeting.org/courses


6 pda.org/courses

2015 Aseptic Processing Training ProgramSession 1: January 26 – 30 and February 23 – 27, 2015 SOLD OUT Session 2: March 23 – 27 and April 13 – 17, 2015 SOLD OUT Session 3: May 18 – 22 and June 15 – 19, 2015 SOLD OUT Session 4: August 3 – 7 and August 24 – 28, 2015 SOLD OUT

Session 5: October 5 – 9 and November 2 – 6, 2015PDA Training and Research Institute | Bethesda, Maryland

Properly evaluate and improve your aseptic processes to ensure sterile products. This course provides the perfect balance of hands-on laboratory and lecture training, equipping you with tools and practical experience you can bring home and apply immediately on the job.

Two five-day sessions allow for an in-depth look into a broad array of topic areas. These two sessions allow for intense, comprehensive learning with minimal impact away from your job/organization.

This is the most complete aseptic processing training program offered with almost 50 hours of hands-on laboratory training and group project work. In addition, there will be extensive coverage of topics during the lecture sessions, all delivered by a faculty with more than 300 years combined experience in aseptic processing.

Early registration is recommended as the Aseptic Processing Training Programs tend to sell-out quickly!

Lead Instructors:David Matsuhiro, Principal Consultant, Cleanroom Compliance, Inc.Harold Baseman, Chief Operating Officer and Principal, ValSource, LLCAnd, eighteen other industry leading experts!

pda.org/2015aseptic

By popular demand, a new fifth session of the Aseptic Processing Training course has been added. There are less than 22 spots available and when they are full, there won’t be another opportunity until 2016.

pda.org/courses 7


Train the Trainer WeekApril 20 – 23, 2015PDA Training and Research Institute | Bethesda, Maryland

Organizations are challenged with finding ways to do more with fewer employees, while at the same time, keeping up with constant changes, regulatory updates and procedure revisions. PDA recognizes this struggle and has teamed up with industry experts to help you and your company by providing training for the trainer to facilitate continuing education.

Qualifying Your SMEs as Trainers (April 20) This course is designed to provide you with the minimum requirements necessary to develop a Trainer Qualification program in house by focusing on the following topics:

• Identification of SMEs• Organizational Readiness• What Belongs in a Department Trainer’s Curriculum• First-Time Observation of Trainers• Department Trainers – Employee Qualification

PrerequisitesParticipants are encouraged to review their current training processes/SOPs as they will be asked to reference them during the course.

Instructor:Vivian Bringslimark, President, HPIS Consulting, Inc.

Learning, Knowledge Management and Impact: Moving from Theory to Practice (April 21 – 22) In this course, key theories that describe knowledge management and how people learn will be examined. You will find ways to apply these theories to some of the practical challenges faced in the pharmaceutical/biopharmaceutical industry, such as knowledge acquisition and transfer, procedure writing and training, new employee on-boarding, web-based learning, and assessment and evaluation. A large portion of this course will involve identifying best practices, both inside the industry and beyond, and using this information, along with the group’s experience and creativity, to reimagine what can be done differently.

PrerequisitesParticipants should have familiarity with current training approaches (e.g., instructional design) and regulatory expectations. Prior to the session, participants will be provided with a reading list of recommended resources.

Instructor:James Vesper, President, LearningPlus, Inc

Designing/Presenting GXP Training Programs to Meet FDA Requirements (April 23)Points to be covered include: reviewing past GMP training topics, conducting a needs analysis, selecting a topic tied to facility quality objectives and FDA quality requirements, brainstorming creative approaches, developing the presentation, maximizing presentation success, evaluating training effectiveness, and audit-proofing training documentation. Using individual and small group exercises, you will leave with a new program well on the way to completion.

Instructor:Elaine Lehecka Pratt, President, Lehecka Pratt Associates, Inc.

pda.org/trainer


Validation of Biotechnology-related Cleaning ProcessesApril 27 – 29, 2015PDA Training and Research Institute | Bethesda, Maryland

This course is ideal for anyone involved in cleaning validation for biotechnology manufacture. Attendees will be provided with a complete, hands-on cleaning validation education program covering both automated (CIP) and manual cleaning for biotech manufacture.

This three-day course includes the use of a CIP skid, which helps the attendees understand everything from the impact of system design on cleanability to how to take swab samples and set acceptance criteria. Participants will gain direct experience setting up an effective cleaning program by going through a systematic approach to cleaning validation. The approach used includes initial evaluation of the equipment to be cleaned, analytical techniques, worst-case conditions, multi-product cleaning, cleaning cycle development, and validation of the cleaning process.

Instructor:Rebecca Brewer, Director, Consultancy Services, Dober Group

pda.org/biotechclean

8 pda.org/courses Source: Texwipe


Lyophilization WeekMay 4 – 7, 2015PDA Training and Research Institute | Bethesda, Maryland

PDA has designed two courses to increase your knowledge on the fundamentals and validation of lyophilization processes.

Fundamentals of Lyophilization (May 4 – 5)This course is designed for participants to develop an understanding of the basic principles and practical aspects of lyophilization technology. Selected topics include an overview of cycles and equipment, vacuum technology use for freeze drying, sublimation in primary drying, desorption during secondary drying, application of principles to product and process development, analysis of product characteristics, and process scale-up to production. Upon completion of this course, attendees will have a working knowledge for practical application in development, production, and evaluation of lyophilized parenterals.

Instructor:Edward H. Trappler, President, Lyophilization Technology, Inc.

Validation of Lyophilization (May 6 – 7)This course is designed to give participants an understanding of the requirements for qualification of a lyophilizer and validation of lyophilization processes. In addition, participants will gain an understanding of the basic principles of lyophilization and the techniques utilized in evaluation of lyophilized materials. The course format will include lecture and discussion of principles, as well as case studies and examples.

Instructors:Karen A. Bossert, PhD, RPh, Vice President, Scientific Affairs, Lyophilization Technology, Inc.Barbara Berglund, Manager, QA, Royal Chemical

pda.org/lyo

pda.org/courses 9

10 pda.org/courses


Recommended Practices for Manual Aseptic ProcessesMay 11 – 12, 2015PDA Training and Research Institute | Bethesda, Maryland

This course provides valuable practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. You will leave with an understanding of how manual and automated aseptic processes differ, and what should be addressed as you work with manual aseptic processes in your own plants. This course will provide a lab-based tutorial of suitable physical techniques, equipment use, and processing operations that can be used to address the challenges posed in the design and control of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical Report addressing the same subject.

Instructor:Olivia Henderson, PhD, Principal Scientist, Protein Pharmaceutical Development, Biogen Idec

pda.org/MAP

NEW COURSE Risk Based Approach for Prevention and Management of Drug ShortagesMay 13, 2015PDA Training and Research Institute | Bethesda, Maryland

This course is based on PDA Technical Report 68 and participants will learn how to apply a proactive risk-based model at a product level to identify drug shortage risks due to manufacturing and quality issues. Attendees will practice how to develop a Drug Shortage Risk Register and a Drug Shortage Prevention and Response Plan using examples and standard templates.

Instructors:Emma Ramnarine, Senior Director, Head Global Biologics QC, GenentechStephan Rönninger, Head External Relations Europe, International Quality, Amgen (Europe GmBH)

pda.org/prevention


pda.org/courses 11


2015 PDA Pharmaceutical Packaging Course SeriesMay 20 – 21, 2015Four Seasons Hotel Baltimore | Baltimore, Maryland

On May 20-21, immediately following the 2015 PDA Pharmaceutical Packaging Conference, PDA will be hosting two courses designed to complement what you learned at the conference. These courses will use a combination of lecture and interactive learning to provide you with more detailed information on the selection of glass containers in pharmaceutical packaging and in the packaging and labeling of drug products.

Selection and Utilization of Glass Containers in Pharmaceutical Packaging (May 20)The course will consist of both lecture and discussion of case studies pertaining to the compatibility of glass with drug products, glass standards, glass handling during the pharmaceutical process, and regulatory requirements. Students will also learn how to write specifications for glass components to obtain consistent, high-quality parts and learn how to identify points in their process that can impact quality. The objective of this course is to give attendees a broad overview of the advantages and disadvantages of glass containers based on the interaction of glass with drug products. Gain an appreciation of the methods that both glass suppliers and pharmaceutical scientists can utilize to increase the compatibility of glass with drugs and reduce glass container defects.

Instructors:Roger Asselta, Vice President, Technical Affairs, Genesis Packaging TechnologiesEdward J. Smith, PhD, Principal Consultant, Packaging Science Resources, LLC

Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Packaging and Labeling of Drug Products (May 21)

This lecture course will utilize the methodology of PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, to identify, assess, manage and use risk to make informed decisions in packaging and labeling operations.

In addition, this course will provide participants with a systematic approach for recognizing and analyzing potential risks by exploring case studies aimed at highlighting the different applications of quality risk management throughout the pharmaceutical and biotechnology manufacturing operations in packaging and labeling. As there are many approaches that can be used for implementation of the ICH Q9 guideline, the course will highlight among other aspects the various risk scoring criteria, emphasizing the various uses of quality risk management across the industry and to point out that there is no one way of applying it.

Instructor:Ghada Haddad, Director, Engineering, Sterile & Validation CoE, Merck and Company, Inc.

pda.org/packagingcourses

12 pda.org/courses

pda.org/courses 13


Technical Development of Prefilled Syringes, Autoinjectors and Injection PensMay 22, 2015Four Seasons Hotel Baltimore | Baltimore, Maryland

On May 22, immediately following the 2015 PDA Drug Delivery Combination Products Workshop, PDA will offer a continuing education course, which will provide guidance and best practices for the design, development, manufacture, testing, quality assurance and marketing strategy for drug delivery systems.

This course will provide guidance and best practices for the design, development, manufacture, testing, quality assurance and marketing strategy for syringes, autoinjectors, pens and related drug delivery systems. Strategy and tactics for developing prefilled syringes, autoinjectors and injection pens will be the primary focus. Setting up project management and design control processes will also be covered. Participants will additionally have exposure to information on stability programs, syringability force testing, human factor study, extractable/leachable and compatibility testing; Lectures, workshops, discussions and case studies will provide the opportunity for both learning and practice.

Instructor:Patty H. Kiang, PhD, Pharmaceutical Consultant, Kiang Consultant Services

pda.org/techdevelop

Management of Aseptic ProcessingJune 1 – 3, 2015PDA Training and Research Institute | Bethesda, Maryland

International regulatory authorities are placing a heavy emphasis on aseptic processing, and it’s difficult to keep pace with what their expectations really are. Are you sure you know what constitutes ‘current’ Good Aseptic Practices? Are you making sound decisions about your aseptic operation? PDA is announcing its newest course in the area of Aseptic Processing – Management of Aseptic Processing. This course will arm managers with the tools they need to make informed business decisions related to aseptically produced products, including selection of aseptic processing technologies, and sourcing decisions.

The instructors in this course will provide you with insight into current inspection trends so you can keep up with the moving target of cGMP. You’ll come away with an understanding of the spectrum of aseptic process designs and operations, and different risk management strategies that should be employed for the most effective cost benefit result. You’ll learn the science behind airflow, aseptic technique, human factors, personnel qualification and tools like smoke studies, media fills and risk assessments.

Do you have the right people in your organization? The right culture? How are you going to recognize the need for, implement, and manage changes within your organization? The course will provide you with the knowledge needed to evaluate investigations, and make informed, risk-based decisions regarding product disposition.

Make sure you and your company remain on the positive side of current and anticipated expectations in the industry by ensuring high-quality products through sound scientific practices, good decision making, and an efficient and effective team.

Instructors:Harold Baseman, Chief Operating Officer and Principal, ValSource, LLCRainer Newman, Independant Expert and Consultant, Aseptic Process Technology, LLC

pda.org/apmanagement

14 pda.org/courses


Process Simulation Testing for Aseptically Filled ProductsJune 4, 2015PDA Training and Research Institute | Bethesda, Maryland

This course will address all the various elements required in the design and execution of a media fill, including personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered. Participants in this course will come away with an up-to-date understanding of current scientific and regulatory advances in the design, conduct and interpretation of process simulations. The knowledge they gain can be applied immediately to media fill operations in their own jobs.

Instructor:Harold Baseman, Chief Operating Officer and Principal, ValSource, LLC

pda.org/simulation

Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing FacilitiesJune 9 – 10, 2015PDA Training and Research Institute | Bethesda, Maryland

This course covers the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments using chemical agents that reduce or destroy microorganisms. While sterile product manufacturing requires the most stringent application, the concepts introduced during the course can also be used to design a program for the manufacture of non-sterile products. The important aspects of the soon-to-be-released Cleaning and Disinfection Technical Report from PDA will also be highlighted.

Instructor:Art Vellutato Jr., President, Veltek Associates Inc.

pda.org/cleaning

pda.org/courses 15


2015 PDA Aseptic Processing – Sterilization Course SeriesJune 11 – 12, 2015Loews Coronado Bay Resort | San Diego, California

Expand your knowledge at the 2015 PDA Aseptic Processing − Sterilization Course Series. Four courses have been developed to educate you on everything from process simulation testing to parametric release.

Process Simulation Testing for Aseptically Filled Products (June 11)This course will address all the various elements required in the design and execution of a media fill, including personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre- and post-incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered. Participants will come away with an up-to-date understanding of current scientific and regulatory advances in the design, conduct and interpretation of process simulations. The knowledge gained by the course participants can be applied immediately to media fill operations in their own jobs.

Instructor:Marsha Stabler Hardiman, Senior Consultant, Concordia ValSource, LLC

Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control (June 11)This course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. Important moist heat sterilization topics also covered by this course include: considerations in the use of steam and water requirements for moist heat processes, fundamentals in the selection and use of biological indicators and chemical indicators, selection of a sterilization process type based on product attributes, and design considerations for key and critical parameters.

Instructor:Michael Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare

Recommended Practices for Manual Aseptic Processes (June 12)This course will provide valuable, practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. Participants will come away with an understanding of how manual and automated aseptic processes differ, and what should be addressed as they work with manual aseptic processes in their own plants. They will also learn how process simulation testing to evaluate manual aseptic processing operations should be designed and carried out. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered.

Instructor:Olivia Henderson, PhD, Principal Scientist, Protein Pharmaceutical Development, Biogen Idec

Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat (June 12)This course is designed to benefit organizations that are pursuing development of a parametric release moist heat sterilization program as well as organizations seeking to improve conventional moist heat sterilization programs. Global parametric release requirements will be summarized along with best demonstrated practices that can be utilized to efficiently comply with these requirements. Topics will include the history of parametric release, limitations of the sterility test, sterilization science (microbiology and thermal science), essential elements of a parametric release program, and recommended submission content. Participants will also examine a case study on the application of quality risk management.

Instructor:Michael Sadowski, Director, Sterile Product Manufacturing, Baxter Healthcare Corporation

pda.org/sterilizationcourses

16 pda.org/courses


2015 PDA Single Use Systems Workshop Course SeriesJune 25-26, 2015PDA Training and Research Institute | Bethesda, Maryland Bethesda North Marriott Hotel and Conference Center | Bethesda, Maryland

This course series builds on the content delivered at PDA’s Single Use Systems Workshop when taken together. When taken alone, it provides a comprehensive look at packaging and processing Extractables/Leachables and critical concepts to consider when implementing a single use system strategy in a pharmaceutical manufacturing process.

Assessing Packaging and Processing Extractables/Leachables Bethesda North Marriott Hotel and Conference Center | Bethesda, MarylandParticipants will review regulations regarding the reporting, identification, and measurement of extractables/leachables (E/L) from packaging materials and product contact items used in drug processing. A detailed discussion on the sources of extractables from materials, such as plastic, glass and rubber, will be included. E/L from packaging, and processing components/materials will also be discussed. Attendees will be shown how to design and execute an E/L study. Attendees will be provided with a synopsis of the current and anticipated regulations and a means to address the issues in a responsible, scientific, and cost-effective manner.

Instructors:Cheryl Stults, PhD, Principal, C & M Technical Consulting, LLCEdward J. Smith, PhD, Principal Consultant, Packaging Sciences Resources, LLC

Single Use Systems for the Manufacturing of Parenteral Products PDA Training and Research Institute | Bethesda, Maryland

This course will provide students with critical concepts to consider when implementing a single use system (SUS) strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.

SUSs that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products will be discussed.

Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a balanced viewpoint, with consideration from engineering, regulatory, quality, project management and accounting. Balancing risks and rewards of an SUS over a Multiple Use System will help determine the most appropriate manufacturing strategy.

Instructor:Robert Repetto, Senior Director, External Affairs, Pfizer, Inc.

pda.org/suscourses

pda.org/courses 17


Application of Phase-Appropriate GMP to the Development of Protein Bulk Drug Substances July 7, 2015PDA Training and Research Institute | Bethesda, Maryland

This course defines current Good Manufacturing Practice (cGMP) principles important for manufacturing therapeutic protein drug substances for use in clinical trials (pre-marketing), and provides examples of approaches toward cGMP compliance during clinical studies. An overview of PDA’s Technical Report 56 is provided, which presents the expectations across regulatory authorities as biopharmaceutical products proceed from the discovery/R&D stage through completion of phase 3 clinical trials. A phase-appropriate approach to the implementation of cGMP; an approach that enables sponsors to supply safe clinical materials for studies in humans while maintaining manufacturing flexibility at non-commercial scales, during scale up and process transfer to commercial facilities, will be introduced.

Instructor:John Geigert, PhD, RAC, President, BioPharmaceutical Quality Solutions

pda.org/bulkdrug

A Former Investigator’s Perspective on Conducting Effective Deviation Investigations, Root Cause Investigations and Corrective and Preventive Actions (CAPA)July 8, 2015PDA Training and Research Institute | Bethesda, Maryland

This introductory course will focus on a quality systems approach toward conducting deviation investigations in accordance with FDA’s current Quality Systems and cGMP compliance expectations. Participants will gain a former FDA investigator’s insight into FDA’s quality systems and compliance expectations associated with deviations (discrepancies), out-of-specification test results, and non-conformance investigations.

Upon completing this course, participants will have a clear understanding of the key elements that must be considered when conducting deviation investigations, proposing corrective and preventive actions, and will understand the difference between corrective vs. preventive actions. FDA compliance issues and concerns will also be addressed.

A combination of lectures and workshop/small group class exercise will be utilized to emphasize and highlight key points.

Instructor:Jeff Yuen, MPH, President and CEO, Jeff Yuen & Associates Inc.

pdas.org/capa

18 pda.org/courses


Moist Heat Sterilization Week July 21 – 23, 2015PDA Training and Research Institute | Bethesda, Maryland

Moist heat sterilization processes are considered to be “special processes” since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. PDA has developed three courses to keep you on track when designing, validating or controlling a properly functioning moist heat sterilization process.

Steam Sterilizers: Getting it Right from the Beginning (July 21)This is a comprehensive course to enable participants to understand sterilization processes using steam, design the right steam sterilizer for particular applications, develop the load and cycle for those applications, perform qualification to demonstrate that the design and development of the processes were robust, and provide ongoing process controls to maintain the qualified state.

Instructors:Christopher J. Smalley, Associate Director, BioSterile Validation, Merck and Company, Inc.Matt Hofacre, Director Application Project Management, Steris Corporation

Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control (July 22)This course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. Important moist heat sterilization topics also covered by this course include: considerations in the use of steam and water requirements for moist heat processes, fundamentals in the selection and use of biological indicators and chemical indicators, selection of a sterilization process type based on product attributes, and design considerations for key and critical parameters.

Instructor:Kevin D. Trupp, Principal Consultant – Sterilization Technology and Compliance, Automated Systems Inc.

Steam in Place (July 23)This course will enable participants to better understand how design and operational concepts can be applied to optimize steam in place cycles (e.g., shorter and more lethal cycles) and also how to select the most applicable validation approaches. Training will also include some exercises using risk assessment tools to determine if the system to be steamed should be considered “sterilized” or “sanitized,” as that decision has a significant impact on the validation approaches that would be utilized for the initial and periodic validations performed on the system. The primary objective of this course is to provide a better understanding of how to design, operate and validate systems that are steamed in place.

Instructor:Kevin D. Trupp, Principal Consultant – Sterilization Technology and Compliance, Automated Systems Inc.

pda.org/moistheat

pda.org/courses 19


Risk-Based Qualification of Sterile Drug Product Manufacturing SystemsJuly 27 – 29, 2015PDA Training and Research Institute | Bethesda, Maryland

This course is designed to teach students the techniques for effective qualification and validation of sterile drug product manufacturing systems. Taught at the PDA Training and Research Institute, this course makes extensive use of the Aseptic Processing Suite to provide a combination of lecture and hands-on learning. Instructors will walk students through the planning, protocol development, execution, and troubleshooting of the qualification of various drug product manufacturing systems, including critical utilities, formulation/compounding, component parts sterilization, filling, and packaging. Lectures and case studies will provide students with the regulatory expectations, industry trends, and best practices for qualification and validation of sterile drug product manufacturing systems utilizing modern risk and science-based decision making approaches.

If you are involved with the planning, documentation, execution, or review of sterile drug product manufacturing system qualification and validation for capital projects or on-going facility operation and remediation, this hands-on course will provide essential knowledge and training in the approaches needed to successfully perform those functions.

Instructors:Walter Henkels, Senior Consultant, Concordia ValSourceMarsha Stabler Hardiman, Senior Consultant, Concordia ValSource, LLC

pda.org/risk

Airflow Visualization Techniques and PracticesAugust 10 – 11, 2015PDA Training and Research Institute | Bethesda, Maryland

In this course, participants will discuss what components should be included in an airflow visualization study, such as intervention assessments, movement effects, regulatory requirements and facility design elements. They will learn how the concept of “first air” is related to product sterility and how unidirectional and turbulent airflow affects it. Participants will also learn how to incorporate these elements into a contamination control program emphasizing good aseptic technique and cleanroom behavior. Participants will get the opportunity to develop a protocol, conduct an airflow study and review their results. They will also learn how to visually document their study in a way that allows the viewer to understand the process at hand.

Instructor:David Matsuhiro, Principal, Cleanroom Compliance, Inc.

pda.org/air


20 pda.org/courses

Validation of Dry Heat Processes Used for Sterilization and DepyrogenationAugust 12 – 14, 2015PDA Training and Research Institute | Bethesda, Maryland

This course is based on PDA’s Technical Report 3, Validation of Dry Heat Processes Used for Depyrogenation and Sterilization. It focuses on the microbiology and engineering qualification of dry heat depyrogenation processes and will provide a foundational understanding of depyrogenation science. These concepts will then be applied in the design and verification of equipment, depyrogenation process development, process performance qualification for new systems and ongoing maintenance of the validated process.

Instructors:James Cooper, Consultant, Endotoxin Consulting ServicesWes Few, Consultant, ValSource, LLC

pda.org/depyro

GMP WeekAugust 17 – 19, 2015PDA Training and Research Institute | Bethesda, Maryland

Learn about GMPs for sterile and biotech products as well as how to apply quality systems to pharmaceutical GMPs.

GMPs for Manufacturers of Sterile and/or Biotechnology Products (August 17)This course discusses the practical implementation of GMPs in facility and equipment design, process design and

operations. You will leave with an understanding of the microbiology of bacteria and their lethality, the regulatory expectations for equipment and utility qualification and sterile process validation in order to assure that the products manufactured are proof-positive sterile.

Instructor:Michael Anisfeld, President, Globepharm Consulting, Inc.

Application of a Quality Systems Approach to Pharmaceutical cGMPs (August 18 –19)This course will define the concepts behind the application of Quality Systems (QS) to drug operations and the specific elements as discussed in the FDA guideline: Management Responsibilities, Resources, Manufacturing Operations and Evaluation Activities. It will also describe the requirements in the ICH Q10 guideline and compare to the FDA document.

Specific discussion on each QS element from a risk-based approach will also be included so that the specific requirements can be prioritized based on the highest impact to product quality.

Instructor:Miguel Montalvo, President, Expert Validation Consulting, Inc.

pda.org/gmp

pda.org/courses 21


Fundamentals of an Environmental Monitoring ProgramSeptember 9 – 10, 2015PDA Training and Research Institute | Bethesda, Maryland

You will have the opportunity to work hands on with environmental monitoring equipment and media to develop a surface and air environmental monitoring program for PDA’s clean room. You will use the information presented in the lectures to determine appropriate sampling sites and methods based on area classification, activities performed and surface type.

Instructors:Dona Reber, SM (NRCM), Global Quality Operations, Microbiology and Aseptic Support, Pfizer Marc Glogovsky, SM (NRCM), Global Business Manager – SMA Division, Veltek Associates, Inc.

pda.org/enviro

NEW COURSE Establishment of a Risk-Based Environmental Monitoring Program September 11, 2015PDA Training and Research Institute | Bethesda, Maryland

This course will present information on the establishment of a risk-based environmental monitoring (EM) program. It will cover both the establishment of new EM programs as well as reassessment of current EM programs to bring them into compliance with industry standards. Routine EM Program requirements and EM program qualification requirements will be reviewed. Instruction will be given on the use of risk tools for determination of microbial contamination sources in production environments and processes, and on the use of EM risk assessment tools.

Instructor:Marsha Stabler Hardiman, Senior Consultant, Concordia ValSource

pda.org/EMP

22 pda.org/courses


2015 Glass Quality, Visual Inspection and Foreign Material Identification Week September 14 – 18, 2015PDA Training and Research Institute | Bethesda, Maryland

PDA is offering three courses to help you develop a comprehensive program designed to identify and classify non-conformities in your containers, visually inspect your final product and to analyze foreign material isolated during your inspections.

Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing (September 14)Through a series of lecture presentations accompanied by visual depictions of glass nonconformities, students will be provided with a review of current best practices for identification and classification of visual nonconformities in glass containers. The course will also present criteria such as the development and use of appropriate sampling plans for incoming inspection of glass containers and the appropriate application of Acceptable Quality Limits for accept/reject decisions. The importance of the partnership between glass manufacturers and the pharmaceutical company using the glass containers in establishing glass container quality specifications will be emphasized.

Instructor:Nicholas R. Debello, Principal, DeBello & Associates LLC

An Introduction to Visual Inspection (September 15 – 16)Covering the fundamentals of visual inspection and their application to injectable products, this course will

be a combination of lecture/discussion and hands-on laboratory exercises used to develop and practice practical inspection skills. The skills developed through this course may be applied to both manual human inspection and automated machine inspection.

Instructors:John Shabushnig, PhD, Independent Consultant, Insight Pharma Consulting, Inc.Ronald Leversee, QA External Operations, Perrigo CompanyMatt Ostrowski, Injectable Inspection Team Leader, Pfizer, Inc.

NEW COURSE Foreign Particulate Examination, Isolation and Analysis (September 17 – 18)Instructors will discuss what foreign particulates are and why it is important to identify their composition and potential sources. Three analytical techniques will be covered – polarized light microscopy, infrared spectroscopy and scanning electron microscopy. Students will get hands-on training in sample preparation, sample analysis and sample interpretation. After the course, students will have developed particle isolation and particle handing skills and be able to explain the analytical methods used in identifying particulate matter.Instructors:Rich Brown, Executive Director, MVA Scientific ConsultantsMary Miller, Executive Director, MVA Scientific Consultants Ming Zhou, Business Development, MVA Scientific Consultants

pda.org/glassqual


Utilization of Statistical Methods for Production MonitoringSeptember 22, 2015PDA Training and Research Institute | Bethesda, Maryland

This course will provide guidance to help attendees identify and use statistical process monitoring methods. The appropriate use of statistical methods will be conveyed at a level and in a way that will be easily understood. The various methods will be described, typical applications will be identified and pros and cons of each method will be examined. Examples of each method will be provided to illustrate how each can be used in a real-world setting.

Instructor:Jason Orloff, Chemical Engineer & Statistician, PharmStat

pda.org/statistics

pda.org/courses 23

24 pda.org/courses


2015 PDA Regulatory Conference Course SeriesOctober 1 – 2, 2015Renaissance Washington DC Hotel | Washington, DC

What do you get when you cross in-depth training, six experts and two days? PDA’s Regulatory Conference Course Series! In two days, you and your colleagues will learn more about risk based product development, quality metrics, root cause investigations and much more!

Risk-Based Product Development Basics for Combination Products: Harmonizing Design Controls and Quality-by-Design in Product Development and Market Authorization Documents (October 1)This course provides an overview of the challenges encountered in developing a combination product. It focuses on drug-device or biologic-device products with an emphasis on how the controlled development process (design control and QbD) and the associated documentation of product and process development can support good regulatory submissions. The objective of the course is to introduce and harmonize the basic requirements of FDA’s design controls (21 CFR 820.30) with Quality-by-Design expectations.

Instructor:Carol DeSain, President, The Tamarack Group – North Shore, LLC

Quality Metrics: Performance Indicators (October 1 – 2)This course will help participants select the appropriate quality metrics, determine how best to collect the data and how to use the data to improve the Quality System. The types of processes to be discussed include the production process; supporting processes, such as change control, training, and validation; supplier processes and materials management.

Instructor:Robert G. Kieffer, PhD, President, RGK Consulting

Root Cause Investigation for CAPA (October 1 – 2)This course will engage participants in learning a systematic, science-based methodology to identify the cause(s) for a decline in the performance of a machine, piece of equipment, product (tangible or intangible), or work process (physical or virtual). Once identified, the methodology determines appropriate corrective actions to restore performance, preventive actions to assure similar issues do not occur, and a control plan to assure the original problem does not return.

Instructor:Tom Weaver, President, Weaver Consulting, LLC


pda.org/courses 25

Process Validation and Verification: A Lifecycle Approach (October 1 – 2)This course is designed to explain and facilitate the implementation of Process Validation (PV) and Continued Process Verification (CPV) from a practical perspective. The three stages of process validation activities will be addressed, from the design stage through commercial production. Participants will gain the knowledge they need to ensure that process validation strategies and approaches are consistent with current regulatory and quality system thinking. Attendees will be able to apply these concepts when they return to their jobs.

Instructors:Scott Bozzone, Sr. Manager, Quality Systems and Compliance- Validation, Pfizer, Inc.Wendy Lambert, Divisional Validation Leader, Global MS&T, Novartis Pharma AG

CMC Regulatory Requirements in Drug Applications (October 2)This course provides a basic understanding of CMC requirements in drug applications. It will help prepare

those in regulatory affairs to better address the key points required in the CMC sections of drug applications. Topics to be covered include CMC in Investigational New Drug (INDs) applications, New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), drug master files, and post-approval change supplements. Compliance to Current Good Manufacturing Practice (cGMP) will also be briefly discussed.

Instructor:Zi-Qiang Gu, PhD, Pharmaceutical Consultant, Former FDA CMC reviewer and GMP Compliance Officer

pda.org/pdacourses

26 pda.org/courses


Filtration WeekOctober 12 – 16, 2015PDA Training and Research Institute | Bethesda, Maryland

Whether you are new to the industry or a veteran in the biopharmaceutical industry, you can enhance your knowledge in the use of filters during PDA’s Filtration Week.

Filters and Filtration in the Biopharmaceutical Industry: Basics Course (October 12 – 13)This highly interactive training course is intended to provide a fundamental understanding of biopharmaceutical filtrations and filters that will enable the participants to concentrate on the use of filters for the demanding and critical operations for the manufacture of aseptic products. Practical applications and experiences of filter usage, economics and performance of system designs, integrity test methods, and process validation of filter devices will be the focus.

Instructors:Maik Jornitz, CEO, G-ConWayne Garafola, Field Application Specialist Biotechnology Division, Sartorius Stedim Biotech

Filters and Filtration in the Biopharmaceutical Industry: Advanced Course (October 14 – 16)This advanced course is a three-day laboratory course comprising 30% lecture and 70% hands-on training. The combination of

theoretical and practical work makes this course a highly valuable learning experience for end-users, trainers and regulators. Coursework includes measurement of unspecific adsorption on different filter membrane polymers and the implication of such adsorption for any filtration process. Since filter sizing and optimal filter combination choice is essential for biopharmaceutical filtration processes, the course also includes filterability trials, sizing and scaling. Interactivegroup work will include determining optimal filter combination for particular case studies detailed by the faculty.

Instructors:Maik Jornitz, CEO, G-ConWayne Garafola, Field Application Specialist Biotechnology Division, Sartorius Stedim Biotech

pda.org/filtration

pda.org/courses 27


Validation of Moist Heat Sterilization ProcessesOctober 21 – 23, 2015PDA Training and Research Institute | Bethesda, Maryland

This three-day course includes lecture and hands-on training in the science of sterilization (microbiology and thermal science) with a fully functional steam autoclave and thermal validation equipment. Bring your challenges to the course and brainstorm with the class and Instructor while running actual loads. The foundational understanding you gain will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control.

Instructor:Deborah Drew, President and CEO, Drew Quality Group, Inc.

pda.org/sterilization

PDA 10th Annual Global Conference on Pharmaceutical Microbiology Course SeriesOctober 22-23, 2015Bethesda North Marriott Hotel and Conference Center | Bethesda, Maryland

The learning doesn’t have to end with the 10th Annual PDA Conference on Pharmaceutical Microbiology. On October 22-23, PDA will be hosting three courses to complement the knowledge you have acquired at the conference!

Investigating Microbial Data Deviations (October 22)

This course will provide practical insights into both the regulatory and scientific elements that must be taken into consideration when investigating microbiological data deviations. Participants will come away with an understanding not only of what the considerations are, but also a practical approach to designing and conducting investigations into microbiological test data that appears inconsistent with expectations and trends.

Instructor:Jeanne Moldenhauer, Excellent Pharma Consulting

Evaluation, Validation and Implementation of Alternative and

Rapid Microbiological Testing Methods (October 22 – 23)This course is designed to provide attendees with an overview of the revised Technical Report No. 33, Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods, and how the report can be used as the basis for the validation and implementation of alternative and rapid microbiological methods (RMMs). Attendees will be immersed in

discussions that will provide a meaningful and understandable roadmap for how to evaluate alternative and RMMs and employ them in their own laboratory and manufacturing areas.

Instructor:Michael J. Miller, PhD, President, Microbiology Consultants, LLC

Regulatory Aspects of Microbiology in a Non-Sterile Environment (October 23)Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to those governing aseptic manufacturing. This course discusses various regulations and how they impact non-sterile manufacturing. Topics include the setting of specifications, development of processes, holding times, preservation issues, cleaning, sanitization and the requirements for the testing for recovered microorganisms.

Instructor:Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC

pda.org/microcourses


28 pda.org/courses

An Introduction to Visual InspectionOctober 28 – 29, 2015PDA Training and Research Institute | Bethesda, Maryland

This course covers the fundamentals of visual inspection and their application to injectable products. Through a combination of lecture/discussion and hands-on laboratory exercises, participants will develop and practice practical inspection skills that can then be applied to both manual human inspection and automated machine inspection.

Upon completion of this course you will be able to:

• Identify applicable international regulatory and compendial requirements for visual inspection• Apply the critical parameters which must be controlled for reproducible inspection results• Use appropriate statistical tools to assess and compare inspection methods• Develop consistent validation strategies for visual inspection processes and equipment

Instructors:John Shabushnig, PhD, Independent Consultant, Insight Pharma Consulting, Inc.Ronald Leversee, QA External Operations, Perrigo CompanyMatt Ostrowski, Injectable Inspection Team Leader, Pfizer, Inc.

pda.org/visualcourse

pda.org/courses 29


Quality Risk Management WeekNovember 9 – 13, 2015PDA Training and Research Institute | Bethesda, Maryland

If improving quality and reducing risk are important to you, then you simply cannot afford to miss this week!

Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations (November 9 –10)This course will provide detailed guidance for application and implementation of quality risk management principles throughout the product lifecycle, with emphasis on quality risk management application during commercial manufacturing, and integrating quality risk management into the Pharmaceutical Quality System. It will build on the content and principles of ICH Q9, Quality Risk Management, and provide case study examples of the application of quality risk management for different types of manufacturing operations such as biotech API manufacturing, drug product manufacturing, packaging and labeling.

Instructors:Jeff Hartman, Director, Validation Quality Assurance, Merck and Company, IncEmma Ramnarine, Senior Director, Head Global Biologics QC, Genentech

Implementation of Quality Risk Management: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances (November 11 – 12)This course will consist of lectures and workshops designed to help participants identify risks in bioprocesses. Participants will work in small groups on open-ended scenarios to identify risk groups and judge their magnitudes and potential impacts. The workshops will include training in particular risk tools that are introduced throughout the course. Participants will gain increased awareness of risks and strategies for risk reduction in bioprocess development and manufacturing.

Instructor:Scott Rudge, PhD, COO, RMC Pharmaceutical Solutions, Inc.

Implementation of Quality Risk Management: Case Studies in the Manufacturing of Pharmaceutical Drug Products (November 11)

This interactive course will provide practical examples of how to use and apply quality risk management in drug manufacturing operations, including the benefits and challenges. Lecture and breakout sessions will provide attendees with practical examples of how to use quality risk management across the product life cycle to improve product quality and compliance. Specific case studies from drug manufacturing will be presented.

Instructor:Ghada Haddad, Director, Engineering, Sterile & Validation CoE, Merck and Company, Inc.

pda.org/riskmanage

30 pda.org/courses


The Quality Culture and its MeasurementNovember 11, 2015Bethesda North Marriott Hotel and Conference Center | Bethesda, Maryland

Learn to evaluate your company culture and improve it with this course!

This course will provide an opportunity to discuss the components of a quality culture, how to measure those components and strategies for enacting change through a combination of lecture and small group exercises.

pda.org/metricscourse

2015 PDA Vaccines Course SeriesDecember 3 – 4, 2015Bethesda North Marriott Hotel and Conference Center | Bethesda, Maryland

The 2015 PDA Vaccines Course Series is made up of two courses that help you and your colleagues learn the current challenges in Vaccines and techniques for modern manufacturing and trend monitoring!

Current Challenges in Vaccines (December 3)You will learn the complexities and unique challenges of the vaccine field when you take this course, and will be able to provide a basis for assessing and proposing resolutions to manufacturing and quality issues. This course will explore the variety of currently licensed vaccines to understand today’s regulatory, quality and manufacturing challenges by reviewing some historical precedents to demonstrate how the unique vaccine regulatory landscape was established. Case studies will be presented to underline topics of particular interest to the field today. The course format will be lecture and discussion.

Instructor:Kirsten L. Vadheim, PhD, Principal Consultant, BioCompliance Consulting, Inc

Modern Manufacturing and Trend Monitoring Techniques for Vaccines (December 4)This course will provide a brief review of effective methods for vaccine manufacturing processes and will also discuss how to maximize controls to meet and exceed current international regulatory expectations. Case studies will be presented to provide practical examples of how to control scale-up, design for quality, operate effective GMP change controls for processes and how to effectively validate systems, facilities and processes. Participants will come away from this course with a better understanding of the speed bumps, road-blocks, common mistakes, complexities and unique challenges of the vaccine manufacturing and quality assurance environments. This course will provide the participant with a basis for better controlling and anticipating emerging manufacturing and quality issues.

Instructor:Anthony M. Luttrell, Principal, Luttrell Consulting Group, LLC

pda.org/vaccinescourses

Turn your knowledge into action in one of the labs –• Microbiology

• Biochemistry

• Cleanroom

Learn from industry experts who –• Developed it

• Invented It

• Tested It

• Know It

60 classroom and lab courses designed to meet the challenges you face –• Aseptic Processing

• Biotechnology

• Environmental Monitoring

• Filtration

• Validation

• Quality Control

• Regulatory Affairs

Begin Your Excellent Experience Today with PDA Education.

pda.org/courses

PDA Education – Where Excellence Begins

32 pda.org/courses


Quality Systems for Aseptic ProcessingNovember 16 – 20, 2015PDA Training and Research Institute | Bethesda, Maryland

This five-day comprehensive training program will give you and your personnel the tools necessary to optimize your Quality Systems associated with Aseptic Processing. Taught by leading industry experts with more than 100 years of combined experience, this course combines the three modes of learning; Visual, Auditory and Kinesthetic, with almost 50% laboratory interaction to maximize information retention. Major topics include; Risk Management, Sterility by Design, troubleshooting and solving sterile filtration issues, investigations and CAPA, and how to effectively implement change within a structured regulated environment.

Instructors:Harold Baseman, Chief Operating Officer and Principal, ValSource, LLCDavid Matsuhiro, President, Cleanroom Compliance, Inc.

Numerous additional industry experts round out the faculty to give you a complete educational experience.

pda.org/qualityAP

Fundamentals of Aseptic ProcessingDecember 7 – 11, 2015PDA Training and Research Institute | Bethesda, Maryland

This 5-day laboratory course will provide you with an understanding of the fundamental principles governing aseptic processing. Systems associated with aseptic processing and how they work together to help ensure a sterile product will be covered.

Upon completion of this course, you will be able to:

• Outline the process steps involved in producing aseptically filled products • Describe how different aspects of aseptic processing are interrelated • Identify microorganisms of specific concern in controlled environments and their origins • Discuss your specific role in aseptic processing and how you fit in • Explain the process steps most commonly described as risky, and how you can manage those risks

Instructors:Carol Lampe, Trainer and ConsultantBrent Watkins, Southeast Sales Manager, Veltek Associates Inc.

pda.org/FAP2

DATES COURSE NAME LOCATION TYPE

7/21 – 7/23 Moist Heat Sterilization Week | pda.org/moistheat Bethesda, MD Lecture7/21 Steam Sterilizers: Getting it Right from the Beginning

7/22 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

7/23 Steam in Place

7/27 – 7/29 Risk-Based Qualification of Sterile Drug Product Manufacturing Systems | pda.org/risk Bethesda, MD Lab


8/10 – 8/11 Airflow Visualization Techniques and Practices – New Course | pda.org/air Bethesda, MD Lab

8/12 – 8/14 Validation of Dry Heat Processes Used for Sterilization and Depyrogenation | pda.org/depyro Bethesda, MD Lab

8/17 – 8/19 GMP Week | pda.org/GMP Bethesda, MD Lecture

8/17 GMPs for Manufacturers of Sterile and/or Biotechnology Products

8/18 – 8/19 Application of a Quality Systems Approach to Pharmaceutical cGMPs

9/9 – 9/10 Fundamentals of an Environmental Monitoring Program | pda.org/enviro Bethesda, MD Lab

9/11 Establishment of a Risk-Based Environmental Monitoring Program – New Course | pda.org/EMP Bethesda, MD Lecture

9/14 – 9/18 Glass Quality, Visual Inspection and Foreign Material Identification Week | pda.org/glassqual Bethesda, MD Lecture/Lab

9/14 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing

9/15 – 9/16 An Introduction to Visual Inspection

9/17 – 9/18 Foreign Particulate Examination, Isolation and Analysis

9/22 Utilization of Statistical Methods for Production Monitoring | pda.org/statistics Bethesda, MD Lecture

10/1 – 10/2 2015 PDA Regulatory Conference Course Series | pda.org/pdacourses Washington, DC Lecture

10/1 Risk-Based Product Development Basics for Combination Products: Harmonizing Design Controls and Quality-by-Design in Product Development and Market Authorization Documents

10/1 – 10/2 Quality Metrics: Performance Indicators

10/1 – 10/2 Root Cause Investigation for CAPA

10/1 – 10/2 Process Validation and Verification: A Lifecycle Approach

10/2 CMC Regulatory Requirements in Drug Applications

10/5 – 10/9 11/2 – 11/6 Aseptic Processing Training Program, Session 5 | pda.org/2015aseptic5 NEW SESSION ADDED Bethesda, MD Lab

10/12 – 10/16 Filtration Week | pda.org/filtration Bethesda, MD Lecture/Lab

10/12 – 10/13 Filters and Filtration in the Biopharmaceutical Industry: Basics Course

10/14 – 10/16 Filters and Filtration in the Biopharmaceutical Industry: Advanced Course

10/21 – 10/23 Validation of Moist Heat Sterilization Processes | pda.org/sterilization Bethesda, MD Lab

10/22 – 10/23 PDA 10th Annual Global Conference on Pharmaceutical Microbiology Course Series | pda.org/microcourses Bethesda, MD Lecture

10/22 Investigating Microbial Data Deviations

10/22 – 10/23 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods

10/23 Regulatory Aspects of Microbiology in a Non-Sterile Environment

10/28 – 10/29 An Introduction to Visual Inspection | pda.org/visualcourse Immediately following the 2015 PDA Visual Inspection Forum

Bethesda, MD Lab

11/9 – 11/12 Quality Risk Management Week | pda.org/riskmanage Bethesda, MD Lecture

11/9 – 11/10 Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations

11/11 Implementation of Quality Risk Management: Case Studies in the Manufacturing of Pharmaceutical Drug Products

11/11 – 11/12 Implementation of Quality Risk Management: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances

11/11 The Quality Culture and its Measurement | pda.org/metricscourse Immediately following the 2015 PDA Pharmaceutical Quality Metrics Conference

Bethesda, MD Lecture

11/16 – 11/20 Quality Systems for Aseptic Processing | pda.org/qualityAP Bethesda, MD Lab

12/3 – 12/4 2015 PDA Vaccines Course Series | pda.org/vaccinescourses Bethesda, MD Lecture12/3 Current Challenges in Vaccines

12/4 Modern Manufacturing and Trend Monitoring Techniques for Vaccines

12/7 – 12/11 Fundamentals of Aseptic Processing | pda.org/FAP2 Bethesda, MD Lab

REGISTRATION INFORMATION: You can register for PDA courses one of three ways: online, fax or mail. To register online, please visit pda.org/courses, find your course of choice and click the Register Now button. You may also submit a registration form along with payment information by fax or postal mail. Please visit pda.org/triregistration for more information. If you have any questions, please call 301-656-5900 ext. 115. Current as of 5/1/15

PDA’s U.S. Education Courses cover a broad range of subject areas reflecting PDA’s core competencies – aseptic processing, biotechnology, environmental monitoring, filtration, microbiology, quality/regulatory affairs, and validation, as well as specialized areas such as lyophilization, pre-filled syringes and visual inspection. Consistent with PDA’s strategic plan, the courses are updated regularly and new offerings are added to reflect current and upcoming technical, scientific and regulatory topics within those core competencies.

pda.org/courses

Parenteral Drug Association U.S. Education Courses

2015 PDA U.S. Education CoursesWhere Excellence Begins

2015 Education Brochure

Documents

Transcript of 2015 Education Brochure