Pharmaceutical Freeze Drying Technology - IMA Group PDA Europe Pharmaceutical Freeze Drying...

2016 PDA Europe Pharmaceutical Freeze Drying Technology

The Parenteral Drug Association presents:

pda.org/EU/FreezeDrying2016

Gold Sponsor

Validation Solutions

27-28 September 2016 Hilton Strasbourg

Strasbourg | France

Register by 27 Aug 2016 and SAVE!

27-28 September | ConferencePharmaceutical Freeze Drying Technology

29 September | Training CourseApplication of a Risk-Based Approach to

Freeze Drying Processes

29-30 September | WorkshopDevelopment of a Freeze Drying Process

https://pda.org/EU/FreezeDrying2016

2 pda.org/EU/FreezeDrying2016

Dear Colleagues,

PDA Europe and the Scientific Program Planning Committee warmly welcome you to the 10th Anniversary of the Pharmaceutical Freeze Drying Technology Conference!

This year, we will meet in Strasbourg/France, 27-28 September 2016 to again share with you updates of various technical and regulatory aspects regarding the complex freeze drying process, and to celebrate the achievements of collaborating in this format for the past ten years!

Since the beginning of this meeting, freeze-drying of biopharmaceuticals has become a routine procedure, leading to an increase in product stability and reaching acceptable shelf lives that benefit patients worldwide.

We believe to have significantly contributed to this progress by offering discourse and bringing together a group of highly qualified and diverse professionals every year.

This year again, our colleagues have worked hard to facilitate a broad science-based discussion of the matter with contributions from pharma industry, manufacturers and regulatory agencies. Regular attendees of this event have gained detailed process knowledge and insights throughout these past ten years, and we are very proud to once again share current and novel concepts such as spray freeze drying, ice-fog nucleation and automated loading/unloading schemes.

Due to the friendly yet professional atmosphere, and with many opportunities for connecting with experts and fellow attendees, business leads have resulted in several fruitful collaborations be-tween pharma and solution providers. The idea for reliable silicone oil detection, for example, was born during such a coffee break when discussions were continued beyond the conference room.

We believe that this event has contributed to the advancement of the Freeze Drying process as a science overall, and we encourage you to get involved!

PDA Europe offers the perfect opportunity to evolve from an attendee to a speaker to a committee member, like we as today’s Conference Chairs have done, thereby supporting your personal and professional development and career paths!

Let’s meet in Strasbourg! We look forward to welcoming you to the PDA Europe Pharmaceutical Freeze Drying Technology Conference!

Sincerely,

WELCOME FROM THE CO-CHAIRS

Harald Stahl, PhD, GEA Pharma Conference Co-chair

Yves Mayeresse, GlaxoSmithKline Vaccines Conference Co-chair


3pda.org/EU/FreezeDrying2016

SCIENTIFIC PROGRAM PLANNING COMMITTEE

S C H E D U L E A T A G L A N C E

27 Sep27 Sep28 Sep

9:00 – 18:10 18:309:00 – 16:45

Pharmaceutical Freeze Drying TechnologyNetworking ReceptionPharmaceutical Freeze Drying Technology

Conference, Exhibition

Conference, Exhibition

29 Sep 9:00 – 18:00 Application of a Risk-Based Approach to Freeze Drying Processes

Training Course

29 Sep30 Sep

9:00 – 18:00 9:00 – 17:00

Development of a Freeze Drying Process Workshop

For latest information, please visit: pda.org/EU/FreezeDrying2016

1 Harald Stahl, Conference Co-Chair, GEA Pharma

2 Yves Mayeresse, Conference Co-Chair, GlaxoSmithKline Vaccines

3 Michele Arduini, IMA Life

4 Raf De Dier, Janssen

5 Jörg Lümkemann, Roche

6 Ingo Presser, Boehringer Ingelheim

7 Falk Klar, PDA Europe

8 Melanie Decker, PDA Europe

1

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2

6

3

7

4

8



CONFERENCE AGENDA

Tuesday, 27 September 2016

9:00 Welcome & Introduction Falk Klar, PDA EuropeHarald Stahl, GEA PharmaYves Mayeresse, GlaxoSmithKline Vaccines

Session 1: Current Manufacturing Topics Moderator: Ingo Presser, Boehringer Ingelheim

Although it is one of the oldest techniques in the pharmaceutical industry for the preservation of unstable materials, there still is an increased demand for lyophilized products and equipment. To accommodate such a growth, the freeze-drying process requires an increased process control, an acceleration of the processing time and upgrades in equipment to remain compliant with changing regulatory requirements. The aim of this session is to provide a better understanding of good lyophilization practices and evolutions to keep freeze-drying competitive as a pharmaceutical processing step.

9:10 Manufacturing Practices - Interfaces Thomas Hense, Baxter

9:40 Case Study on the Evolution, Upgrade and Performance of a Lyo Plant with the Aim to Achieve 100 % Green Alternative

Christophe de St Leger, IMA Life

10:10 New Processes for Freeze-Drying in Dual Chamber Systems Tobias Werk, Roche

10:40 Q & A, Discussion

10:50 Coffee Break, Poster Session & Exhibition

Session 2: Process Control Moderator: Michele Arduini, IMA Life

Freeze drying is a process that is always running on the edge of what is feasible from a process, product and equipment perspective. Thisis given by the simple fact that thermodynamics demand it to run like this. Control of all relevant input parameters like vacuum and shelf temperature, and close monitoring of the process are of utmost importance. Modern techniques give better access and control of thefreeze drying process. This session will shed light on these techniques.

11:20 Continuous Development of PAT Tools to Better Understand the Freeze Drying Process Cycle

Arnab Ganguly, IMA Life

11:40 The Challenge of Accurate Pressure Monitoring Daniel Kuchenbecker, Pfeiffer Vacuum

12:10 Lunch Break, Poster Session & Exhibition

13:10 Impact of Temperature Edge Effects on Water Content in Freeze Dried Finished Product

Jesper Davidson, Novo Nordisk

13:40 Evaluation of Heat Flux Measurements and Headspace Moisture Analysis for Lyophilization Process, Product, and Equipment Characterization

Thomas Bosch, Coriolis Pharma


14:30 Coffee Break and Cutting of the 10th Anniversary Cake

13 Sep 2016



CONFERENCE AGENDA

Session 3: Quality by Design, Process Analytics Technology Moderator: Raf De Dier, Janssen

‘Process analytical technology’ and ‘Quality by Design’ have become topics of routine discussion in the pharmaceutical industry. Yet, many are finding it difficult to implement these tools and techniques into the daily production area and provide confidence that quality indeed is designed in - and risk reduced. In this session, we will go beyond the basic principles of PAT & QbD serving those who require a more integrated approach to these initiatives. Focus will be placed on reports of implementation and case studies from companies, the development of new procedures as well as new trends in sensor technology in freeze-drying.

15:00 The Application of Through Vial Impedance Spectroscopy for Process Parameter Determination in Freeze-Drying Method Development

Geoff Smith, De Montfort University

15:30 Transfer of a Legacy Product between two Sites: How to Increase Process Knowledge Leading to Process Improvement

Erwan Bourles & Benoit A. Moreau, GlaxoSmithKline

16:00 Increasing Confidence in Lyophilization QbD: Integration of Pre-process, In-process and Post-process Analytics

Kevin Ward, Biopharma



Session 4: Container Closure Integrity Testing Moderator: Yves Mayeresse, GlaxoSmithKline Vaccines

Container closure integrity for freeze-dried products becomes a topic of increased interest, due to a difficult detectability of cracks at visual inspection steps following the presence of a cake inside the vial. Different technologies performing 100% detection are available on the market .During this session, after a short introduction, detection methods will be reviewed and applied to case studies. The aim is to provide the audience a good understanding of the advantages and limitation of the available technology existing on the market.

17:15 Introduction to CCI Testing for Freeze-Dried Products Yves Mayeresse, GlaxoSmithKline Vaccines

17:35 Laser-based Headspace for CCIT of Lyo Product During the Full Product Life Cycle

Derek Duncan, LIGHTHOUSE

17:55 Total Quality on Lyo Containers Roland Koch, Wilco

18:15 State-of-the-Art 100 % Container Closure Integrity Testing and Headspace Gas Verification: An Integrated Approach for Freeze Dried Parenteral Products. Insights, Rationales and Findings from a Case Study

Andrea Simonetti, Bonfiglioli

18:35 Panel Discussion with all Session Speakers

19:00 Summary & Networking Reception



CONFERENCE AGENDA

Wednesday, 28 September 2016

K E Y NOTE

9:00 Continuous Freeze Drying of Parenteral Vials:A Promising Outlook on Available Technologies

Georg Frinke, Bayer Pharma


Session 5: Trends & New Concepts Moderator: Joerg Luemkemann, Roche

Freeze drying is increasingly better understood from a scientific perspective. We gain deeper understanding not only about the fundamental physics of this unit operation, but we can better and better understand the complex aspects that lead to success or failure during the lyophilization process. We start to use this in-depth knowledge to make freeze drying faster, safer, cheaper, or more compatible with patients’ needs. This session will give an overview about some initiatives in this context.

10:15 How to Manage Scale-up Using Design Space Approach Bernadette Scutella, GlaxoSmithKline

10:45 Freeze Dryer Equipment Limit Characterization: Eliminating Trial-and-Error in Scale-up

Arnab Ganguly, IMA Life


11:45 Bulk Lyophilization of Microspheres in an Industrial Scale Matthias Plitzko, Meridion Technologies

12:15 Freeze Drying using New Technology Stéphane Guillaud, ellab

12:45 Comparison of the In-Vitro Release Characteristics of Freeze Dried Biomatrix Containing an Soluble Drug

Sophie Declomesnil, Synerlab


13:30 Lunch Break, Poster Session & Exhibition



CONFERENCE AGENDA

Session 6: PDA Interactive: Knowledge Meets Discussion

Moderator: Falk Klar, PDA Europe

QUESTION 1 What is an Appropriate

Acceptance Level of Leak Rates?

QUESTION 2 What are Appropriate

Acceptance Criteria for Cleaning in Place Practices?

QUESTION 3 Should Freeze Drying

Operations be Included in Media Fill?

Moderator: Joerg Luemkemann, Roche

Moderator: Harald Stahl, GEA

Moderator: Yves Mayeresse, GlaxoSmithKline

14:35

14:55

15:00

15:20

15:20

15:40


16:15 Presentation / Summary of Roundtables All Moderators

16:45 Farewell Remarks & End of Conference Falk Klar, PDA Europe


Wireless Vacuum Sensor

Sky System for Wireless Real-Time Data

LYO Shuttle for Autoloading

E-Val Pro Wired System

Validation Solutions

Lyophilization Solutions

iPhone App for Real-Time Data &

Report Access

Vial Product MappingShelf Mapping

Ellab SarlTel: +33 344 2302 [email protected]

www.ellab.fr


The Parenteral Drug Association presents...

29 September 2016Application of a Risk-Based Approach to Freeze-Drying Processes One-Day Training Course

29-30 September 2016Development of a Freeze-Drying Process Two-Day Workshop

Training & Education Program



Application of a Risk-Based Approach to Freeze-Drying Processes

ONE-DAY TRAINING COURSE

Who Should Attend:

This course is designed specifically for people having an interest in freeze-drying. The audience can come from the various horizons of people performing technical risk assessment, including, but not limited to: production, quality assurance, validation, engineering and develop-ment specialist.

Learning Objectives:

Upon completion of this course, the attendee will be able to:

• Better understand the freeze-drying process explained through the different examples

• Master ICH Q9 approach in term of risk based approach

• Recognize a critical parameters for a process

• Score the criticality of a parameters

• Work in team by reaching consensus around criticality levels

OverviewOne master piece of current process validation approach is risk analysis. It allows defining and measuring the critical parameters of the process for which a specific level of scrutiny is necessary in order to end-up with a robust process under control. The objective of this course is to give an understanding of risk management through ICHQ9 applied to the freeze-drying process. The first part will review the guidelines, the Freeze-Drying process and the tools available to score the risks. The second part will be fully interactive. Participants will express their views in terms of detectability, occurrence and control of the various risks linked to the Freeze-Drying process. The session will be subdivided into different chapters: Product, Process, Critical Quality Attributes, Ancillary Function of the equipment and Aseptic Level. The different tools to perform risk analysis will be described and the main focus will be on an FMEA (Failure Mode and Effects Analysis) approach. The output of the workshop is a table consisting of the different parameters with their associated level of criticality that will be shared with the participant

Yves Mayeresse, GlaxoSmithKline Vaccines

Yves Mayeresse is director in manufacturing technology inside MSAT by GlaxoSmithKline Vaccines. He has more than twenty years of experience in the pharmaceutical sector and has worked for different companies. Yves has managed activities such as parenterals production, set-up of new Freeze-Drying facilities, design of Freeze-Drying cycle and development of new stabilizers for freeze-dried products. Transfer of product to-wards different internal and external site. He has worked on the industrialization of new freeze-dried prod-

ucts and then in the technical life cycle management. Now Yves is focusing on different technologies used for the primary and secondary operations. He is an engineer in biochemistry, He has written articles about Freeze-Drying science and he is a regular speaker for conferences on Freeze-Drying.



Thursday, 29 September 2016 9:00 – 17:00

9:00 Theoretical Part ▶ Brief review of ICH Q9 ▶ Description of Freeze-Drying Technology – The equipment – The process – The product and the primary packaging items – The ancillary function (SIP, CIP) – Aseptic level (automatic loading, people presence)▶ Tools Presentation – Input / Output parameters – Dependent / Independent parameters – CQA: Critical Quality Attributes – FMEA approach – Examples

10:30 Coffee Break

11:00 Practical Part▶ Team rule and organization▶ Part I: Product – Independent parameters linked to formulation – Independent parameters linked to freeze-dryer load▶ Part II: Process – Independent parameters linked to the freeze-dryer

12:30 Lunch

14:00 Practical Part▶ Part II (continued): Process – Independet parameters that are measured and controlled during the cycle – Dependent parameters linked to the freeze-drying cycle▶ Part III: Critical attributes linked to freeze-drying process▶ Part IV: Ancillary Function – SIP

15:30 Coffee Break

15:45 Practical Part▶ Part IV (continued): Ancillary Function – CIP▶ Part V: Aseptic Level

16:30 Conclusions• – Q&A• – Feedback about the approach

17:00 End of Training Course

ONE-DAY TRAINING COURSE



Development of a Freeze-Drying ProcessOverviewThis workshop will give a thorough introduction into the Physics and Thermodynamics of Freeze-Drying. This seminar comes with an additional overview about technical aspects to be considered and gives an overview about current technologies available on the market. It is creat-ed to introduce all people who are professionally linked to Freeze-Drying and might be of special interest for cycle developers (R&D), upscale & transfer specialists, project managers & engineers, process & site engineers, qualification & validation specialists. Open problem examination allows you to bring in a current problem linked to Freeze-Drying. The group will discuss and evaluate possible approaches for troubleshooting.

Georg Frinke, Bayer Pharma

Georg holds a degree in Engineering from UAS, Cologne, Germany. He is Process Engineer at Bayer Pharma and responsible for the technical operation of the parenteral facility. Previously, he worked as Process Engi-neer for Optima (Klee) and GEA Lyophil / Steris. Among others he is specialized in the development of custom-ized Freeze-Drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.

TWO-DAY WORKSHOP

Who Should Attend:

• Cycle Developers (R&D)

• Upscale & Transfer Specialists

• Project Managers & Engineers

• Process & Site Engineers

• Qualification & Validation Specialists

• Members of Parenteral Production Teams

Learning Objectives:

Upon completion of this course participants will know the basic principles of all Freeze Drying aspects:

• Physical/Thermodynamic Theory of Nucleation, Subli-mation and Desorption

• Technical & Technological Solutions to accomplish a standard process

• Based on the prior theory, several Hands-on-sessions provide practical knowledge to design a freeze-drying process

• Basics of qualification of a freeze Dryer



TWO-DAY WORKSHOP

Thursday, 29 September 2016 9:00 – 18:30

THEO R Y

9:00 Introduction• Introduction into Drying Technologies• Overview of the Freeze Drying Process• Properties of Water• Properties of Heat Transfer during

Lyophilization

10:00 Nucleation• Scientific Basics• Freezing Process• Sensors & PAT• Hands-on

11:00 Coffee Break

11:30 Nucleation (Cont.)• Hands-on: Freezing of Sucrose in a Lyo with

integrated thermos resistant measurement

13:00 Lunch Break

14:00 Sublimation• Scientific Basics• Drying Process• Sensors & PAT• Hands-on

16:00 Coffee Break

16:30 Desorption• Scientific Basics• Residual Moisture• Sensors & PAT• Hands-on

Bring in your Questions:Real problems of Freeze Drying can be presented and will be discussed as a group

18:30 End of Day 1

Friday, 30 September 2016 8:30 – 17:00

TECHN O LO G IE S & PR AC TI CE

8:30 Repetition of Previous Day Theory & Transfer of a Freeze Drying Cycle

9:00 Hands-On: Recipe Development

11:00 Coffee Break

11:30 Module Structure of a Freeze Dryer• Chamber & Shelf System• Condenser & Main Valve• Venting System / Filter Test• Refrigeration• Vacuum System• CIP / SIP Systems

12:30 Lunch Break

14:00 Module Structure of a Freeze Dryer (Cont.)• System Benchmarks• Performance Criteria• Installation vs. Process• Design Criteria & Engineering Aspects

15:00 Coffee Break

15:30 Hands-on: • Evaluation of the Lyo experiment & samples

of collapsed probe

16:30 Qualification Validation Hints for the SAT

17:00 End of Workshop



V E N U EHilton Strasbourg 1 Avenue Herrenschmidt Strasbourg, F - 67000 France Tel +33-388-371-010 Fax +33-388-255-503 www.placeshilton.com/strasbourg

Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.

CO NTAC T I N FO R M ATI O NConference Inquiries Melanie Decker Director Events & Exhibitions [email protected]

Conference Program Inquiries Sylvia Becker Manager Programs & Events [email protected]

Registration & Customer Care Tel: +49 30 4365508-10 [email protected]

Education Program Inquiries Elke von Laufenberg Manager Training & Education [email protected]

Exhibition/Sponsorship Inquiries Creixell Espilla-Gilart Manager Exhibition & Sponsorship [email protected]

G E N E R A L A D D R E S SPDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66

CO N F E R E N C E R EG I S TR ATI O N H O U R STuesday, 27 September: 8:00h – 16:00h Wednesday, 28 September: 8:00h – 12:00hCO U R S E R EG I S TR ATI O N H O U R SThursday, 29 September: 7:30h – 16:00h

TO E X H I B ITExhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.

S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your

needs with your registration form. Specific questions can be directed to [email protected].

INFORMATION

Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lufthansa.com/event-booking_en and enter the access code DEZZYGH in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to [email protected] and providing the access code as a reference.

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D I R EC TI O N S

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Pharmaceutical Freeze Drying Technology27-28 September 2016 | Strasbourg | France

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ONLINE: pda.org/EU/FreezeDrying2016FAX: +49 30 4365508-66EMAIL: [email protected] MAIL: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

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All fees given in Euro and excluding VAT (20 %)Conference (27-28 September) netPDA Member 1495Nonmember 1745

Two-Day Workshop (29-30 September)Development of a Freeze Drying ProcessAll Participants 1495

One-Day Training Course (29 September)Application of a Risk-Based Approach to Freeze Drying ProcessesAll Participants 695

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Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact us at [email protected]. Other discounts cannot be applied.

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General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 [email protected]

Conference InformationMelanie DeckerDirector Events & ExhibitionsTel: + 49 30 [email protected]

Training Course InformationElke von LaufenbergManager Training & EducationTel: + 49 30 [email protected]

LegendIG – Interest Group MeetingTC – Training CourseWS – Workshop

2 0 1 6 P D A E U R O P E A C T I V I T I E S & E V E N T S 19 September

20-21 September

22 September

22 September

22-23 September

22-23 September

22-23 September

22-23 September

Smart Devices for Improved Clinical Outcomes

9th Workshop on Monoclonal Antibodies

Elastomers

From Gene to Product –

Tailormade Strategies for High Level Expression of Biologicals

CMC Regulatory Compliance for Biopharmaceuticals

Extractables and Leachables

Introduction to Aseptic Processing Principles

The Metrics of Process Monitoring & Understanding the Risks of Variation

WS

WS

TC

TC

WS

TC

TC

Rome, Italy

27-28 September

29 September

29-30 September

Pharmaceutical Freeze Drying Technology | Conference

Application of a Risk-Based Approach to Freeze-Drying Processes

Development of a Freeze Drying Process

TC

WS

Strasbourg, France

5-6 October Current Challenges in Aseptic Processing, Potential Changes in

EMA / PIC / S Annex 1 Revision

WSDublin, Ireland

10 October

11-12 October

13 October

13-14 October

14 October

Schiphol Airport Site Visit & On-Site Workshop “Pharma by Road”

Pharmaceutical Cold & Supply Chain Logistics | Conference

Good Qualification Practice of Pharma Storage & Transportation

Equipment

Secure Cold Chain Practices

Supply Chain Strategies for API and Drug Product

TC

TC

TC

TC

Amsterdam,

The Netherlands

24 October

25-26 October

27-28 October

27 October

Particle Identification in Parenterals

Visual Inspection Forum

An Introduction to Visual Inspection: A Hands-on Course

Testmethoden für vorbefüllte Spritzen (PFS)

TC

TC

TC

Berlin, Germany

8-9 November Data Integrity WS Berlin, Germany

14 November

15-16 November

17 November

17-18 November

17-18 November

17-18 November

17-18 November

Managing Single- and Multi-Source Supply Chain Challenges

Outsourcing & Contract Manufacturing | Conference

Quality by Design for Biopharmaceuticals

Practical Guide for Root Cause Investigations – Methodology & Tool Kit

Outsourcing, Technology Transfer, and CMO-Client Relationships

Risk Management in Technology Transfer

Basics of Successful Auditing

TC

TC

WS

TC

TC

WS

Barcelona, Spain

24-25 November Track und Trace-Implementierung von Serialisierung TC Leipzig, Germany

2 0 1 7 P D A E U R O P E A C T I V I T I E S & E V E N T S14-15 February

Pharmaceutical Microbiology | Conference

Microbiology in Pharmaceutical ManufacturingPorto, Portugal

Subject to change For latest info: europe.pda.org Shortlist 13 Sep 2016

https://www.pda.org/pda-europe/home/

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