The Parenteral Drug Association Presents: Pharmaceutical Quality System ...€¦ · the...

The Parenteral Drug Association Presents:

Pharmaceutical Quality System

(ICH Q10) Conference

November 5-6, 2012 Keio Plaza Hotel | Tokyo, Japan

www.pda.org/japanICHQ10

Thisconference

is supported by


Program Planning Committee

A Message from the Program Chairs

Co-Chairs:

Richard L. Friedman U.S. Food and Drug Administration

Yukio Hiyama, PhDNational Institute of Health Sciences

Masashi ImamuraNichi-iko Pharmaceutical Ltd.

Junko Sasaki Dainippon Sumitomo Pharma

David ChesneyPAREXEL Consulting

Richard Johnson PDA

Wanda Neal, CMPPDA

Janeen Skutnik-Wilkinson Pfizer, Inc.

Tetsuhito TakaradaMochida Pharmaceutical Co. Ltd.

Anders Vinther, PhDGenentech, Inc.

Neil Wilkinson David Begg Associates

Do you have a current understanding of how to build a quality system that ensures better processes and product quality? Are you aware of current regulatory expectations? Do you know the total cost of poor quality to your operations? If you are a technical experts, supervisor, senior leader or responsible for the bottom line in a pharmaceutical manufacturing business and want to maintain a competitive quality and business advantage, the Pharmaceutical Quality System (ICH Q10) Conference is the conference to attend in 2012.

PDA and U.S. FDA have created a special joint conference dedicated to teaching the principles of ICH Q10. This will be a unique opportunity to learn these principles from companies that have implemented a Pharmaceutical Quality System across the product lifecycle according to the ICH Q10 model. Those companies are reaping the benefits that come from establishing and maintaining a state of control, continual improvement, enhancing regulatory compliance and meeting quality objectives every day.

While this conference is intended to explain the principles of ICH Q10, it is not a conference that only tells you what ICH Q10 says. It is an event where you can learn the practicalities of how to implement Q10 based on real-life case studies. It will show you how senior management commitment and involvement is vital. This conference has already been held in the U.S. and in Brussels drawing on the best industry and regulator contributors on this topic from both the United States and Europe and now from Japan. This time, we are pleased to share the Japan view that is supported by PMDA and JPMA. Moreover, key regulators from these areas will also share their views on the necessity of a Pharmaceutical Quality System.

You should attend this conference if you are a decision-maker at mid-level or senior level, or a professional working at site or corporate level in the following areas:

• Quality Assurance• Manufacturing, Operations and

Engineering• 6-sigma and Quality Risk Management

• Supply chain• Pharmaceutical Development and CMC• Regulatory Affairs

Sincerely,

Co-Chairs, Pharmaceutical Quality System (ICH Q10) Conference Program Planning Committee

Richard L. Friedman U.S. Food and Drug Administration

Masashi ImamuraNichi-iko Pharmaceutical Ltd.

Yukio Hiyama, PhDNational Institute of Health Sciences

Junko Sasaki Dainippon Sumitomo Pharma


Pharmaceutical Quality System (ICH Q10) ConferenceNovember 5-6, 2012 | Keio Plaza Hotel | Tokyo, Japan

Monday, November 5, 2012 Agenda7:00 a.m. – 5:00 p.m.Registration Open

7:00 a.m. – 8:30 a.m.Continental Breakfast

8:30 a.m. – 8:40 a.m. Welcome and Opening Remarks from Co-Chair of the Planning Committee Richard Friedman, Associate Director, OMPQ, CDER, FDA and Co-Chair, Program Planning Committee

8:40 a.m. – 10:00 a.m.P1: Pharmaceutical Quality System Moderator: Junko Sasaki, QA Principal, Dainippon Sumitomo and Co-Chair, Program Planning Committee

Session Description: Why is a strong Quality System so fundamental to achieving and maintaining operational excellence? What can we learn from other industries? What are the cost benefits of more effective and efficient manufacturing? In the opening session, senior leaders will discuss how the industry and consumers benefit when science-based risk management is used throughout the lifecycle to assure a robust state of control. The session will address the tangible quality-business synergy reaped by “learning organizations” who proactively seek out sources of variability through daily vigilance and take advantage of contemporary technological solutions to improve product quality.

8:40 a.m. – 9:10 a.m.Introduction to Quality Systems ICH Q10MHLW Presenter Invited

9:10 a.m. – 9:40 a.m.Industry Keynote Anders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Roche

9:40 a.m. – 10:00 a.m. The Cost of Non-Compliance and Other IndustriesG.K. Raju, PhD, CEO, Light Pharma, Inc. (invited)

10:00 a.m. – 10:30 a.m.Refreshment Break

10:30 a.m. – 12:00 p.m. P2: Pharmaceutical Quality System – ContinuedModerator: Anders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Roche

Session Description: Why is a strong Quality System so fundamental to achieving and maintaining operational excellence? What can we learn from other industries? What are the cost benefits of more effective and efficient manufacturing? In the opening session, senior leaders will discuss how the industry and consumers benefit when science-based risk management is used throughout the lifecycle to assure a robust state of control. The session will address the tangible quality-business synergy reaped by “learning organizations” who proactively seek out sources of variability through daily vigilance and take advantage of contemporary technological solutions to improve product quality.

P2: Pharmaceutical Quality System – Continued (continued)

10:30 a.m. – 11:00 a.m.U.S. Regulatory PerspectivesRichard Friedman, Associate Director, OMPQ, CDER, FDA

11:00 a.m. – 11:30 a.m.Japan Regulatory PerspectivesTakao Kiyohara, PhD, Advisory Expert, Pharmaceuticals and Medical Devices Agency (PMDA)

11:30 a.m. – 12:00 p.m.Q&A – Panel Discussion P1 & P2

12:00 p.m. – 1:00 p.m.Lunch

1:00 p.m. – 2:30 p.m. P3: Management ResponsibilityModerator: Neil Wilkinson, Senior Partner, NSF-DBA

Session Description: ICH Q10 deliberately brings to the forefront the criti-cal area of management responsibility within a Pharmaceutical Quality System (PQS). Deming recognized this 50 years ago, and it subsequently became a key part of the ISO 9000 series of Quality Management stan-dards. ICH Q10 aims to reinforce the importance of management in establishing and maintaining a companywide quality culture and an effective PQS that assures a state of control and drives improvement. In this session we will hear how these concepts are used in practice within companies, and throughout their supply chains for outsourced activities and purchased materials. We will also hear the regulators’ current ex-pectations as to how management should oversee the PQS.

1:00 p.m. – 1:30 p.m.What QS Means to Regulators and How Management Should Oversee the SystemEU Regulatory Presenter Invited

1:30 p.m. – 2:00 p.m.Case Study: Role of Management to Drive Industry ImprovementAnders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Roche

2:00 p.m. – 2:30 p.m.Case Study: Use of Management Review to Drive Quality and Business ImprovementXiao Zhijian, Regional Quality Director, Astra Zeneca

2:30 p.m. – 3:00 p.m.Refreshment Break


Monday, November 5, 2012 – Tuesday, November 6, 2012 Agenda (continued)

Tuesday, November 6, 2012

7:00 a.m. – 5:00 p.m.Registration Open

7:00 a.m. – 8:00 a.m. Continental Breakfast

8:00 a.m. – 9:30 a.m. P6: Quality System Enablers: Knowledge Management and Quality Risk ManagementModerator: Barbara Mary Allen, Director Global Quality Systems, Eli Lilly & Company

Session Description: The lifecycle of a product can extend over many decades and so it is important that product and process knowledge is acquired, analyzed, stored and disseminated in a systematic manner. Having knowledge enables confident quality risk management to assure quality. Use of structured, formal risk management methodology facilitates consistent science-based decision-making related to products and process controls. Speakers at this session will share how these key topics relate to their quality management system and achievement of quality objectives.

8:00 a.m. – 8:30 a.m.Case Study: Knowledge Management: An Iterative Process Marty Lipa, Director, Knowledge Management Leader, Global Science, Merck & Co., Inc.

8:30 a.m. – 9:00 a.m.Regulatory Perspective on QRM and Knowledge ManagementEU Regulatory Presenter Invited

9:00 a.m. – 9:30 a.m. Q&A/Discussion

9:30 a.m. – 10:00 a.m. Refreshment Break in Exhibit Area

10:00 a.m. – 11:00 a.m. P7: Establishing and Maintaining a State of ControlModerator: Yukio Hiyama, PhD, Visiting Scientist, National Institute of Health Sciences and Co-Chair, Program Planning Committee

Session Description: As defined by Q 10 a state of control is a condition in which the set of controls consistently provides assurance of continued process performance and product quality. This session will discuss the effective monitoring and control systems that can achieve assurance of continued suitability and capability of processes. Featured in this session will be how effective monitoring can support these goals and how they enable lifecycle approaches to validation, i.e., continued process verification. This session applies to both conventionally manufactured products and those that feature advanced manufacturing and control technologies that enable innovations in process validation.

3:00 p.m. – 4:30 p.m. P4: Management Responsibility – ContinuedModerator: Neil Wilkinson, Senior Partner, NSF-DBA

Session Description: ICH Q10 deliberately brings to the forefront the critical area of management responsibility within a Pharmaceutical Quality System (PQS). Deming recognized this 50 years ago, and it subsequently became a key part of the ISO 9000 series of Quality Management standards. ICH Q10 aims to reinforce the importance of senior management in establishing and maintaining a companywide quality culture and an effective PQS that assures a state of control and drives improvement. In this session we will hear how these concepts are used in practice within companies, and throughout their supply chains for outsourced activities and purchased materials. We will also hear the regulators current expectations as to how management should oversee the PQS.

3:00 p.m. – 4:00 p.m.Case Study: Management of Outsourced Activities and Purchased Materials: Addressing the Interfaces and Management of Supply Chain (APIs and Excipients)Janeen Skutnik-Wilkinson, Director, Quality and Regulatory Policy, Pfizer, Inc.

4:00 p.m. – 4:30 p.m.Q&A /P3 & P4 Panel Discussion

4:30 p.m. – 5:30 p.m. P5: Lifecycle GoalsModerator: Richard Johnson, President, PDA

Session Description: While the PQS is applicable from development through to product discontinuation, certain elements of the PQS become more and less relevant over the lifecycle. The principles of Quality by Design can be embraced during development stage to help assure a product can be successfully commercialized using effective manufacturing and testing approaches. This session will look at how the elements and the tools of the PQS can be applied to development of drug substance and drug product, and enhance the potential for smooth technology transfer into commercial launch. Moreover, this session will look at lessons learned through commercialization and post market surveillance to effect continuous improvement of the product.

4:30 p.m. – 4:50 p.m. Technology TransferNeil Wilkinson, Senior Partner, NSF-DBA

4:50 p.m. – 5:20 p.m. Case Study: Commercial Manufacturing Tetsuhito Takarada, Advisory Deputy Director/QA, Mochida Pharmaceutical Co., Ltd

5:20 p.m. – 5:30 p.m. Q&A/Discussion

5:30 p.m. – 6:30 p.m.Networking Reception



Tuesday, November 6, 2012 Agenda (continued)

1:00 p.m. – 2:30 p.m. P9: Pharmaceutical Quality System Elements: Continual Improvement of the Process (CAPA)Moderator: David Chesney, Vice President, Strategic Compliance Services, PAREXEL Consulting

Session Description: An effective CAPA system has been an expectation for many years for companies operating to ISO 9000 Quality Management standards, including Medical Devices operating to ISO 13485. The Pharmaceutical Industry has over last decade put significant effort and resources, in a reactive mode, to managing and investigating deviations, resulting in corrective actions. However, there has been less focus on proactively undertaking preventative actions within the CAPA system. ICH Q10 requires an effective CAPA system that identifies areas that need special attention as product and process understanding expands, and implements and monitors effectiveness of related improvements. It is essential that the CAPA system does not work in isolation and that there are strong linkages with other aspects of the PQS, including Management Review. In this session speakers will present real examples of how a CAPA system can be linked within the PQS to contribute to continual improvement and a reduction in repeat issues.

1:00 p.m. – 1:30 p.m.CAPA Steven Mendivil, Executive Director International Quality External Affairs, Amgen, Inc.

1:30 p.m. – 2:00 p.m.Process ImprovementVivianne Arencibia, Vice President, Quality, Novartis

2:00 p.m. – 2:30 p.m. Management Support for Continual ImprovementSusumu Endo, Global Quality Assurance Department, Takeda Pharmaceutical Co., Ltd

2:30 p.m. – 3:00 p.m. Q&A/Discussion

3:00 p.m. – 3:15 p.m.Refreshment Break

3:15 p.m. – 3:45 p.m. P10: Change ManagementModerator: Barbara Mary Allen, Director Global Quality Systems, Eli Lilly & Company

Session Description: The management of change is critical in our business, whether it concerns changes to our facilities, products, processes, equipment, computerized systems, etc. Our change management system has on the one hand to be robust enough to deal with both major change and small incremental change, but also simple and efficient enough on the other hand for people to easily understand and apply correctly. While change management systems are generally well understood and defined, lack of timely and thorough change management can lead to lingering or new quality and compliance issues. This session will reinforce the importance of carefully managing all changes, even if a change appears to be small.

P7: Establishing and Maintaining a State of Control (continued)

10:00 a.m. – 10:30 a.m.State of Control Over the Lifecycle and Process Validation (New and Legacy Products)Richard Friedman, Associate Director, OMPQ, CDER, FDA

10:30 a.m. – 11:00 a.m.Case Study: Conventional and Modernized Process using Knowledge from Development and Lifecycle Monitoring to Support Continued Product Verification Barbara Mary Allen, PhD, Director, Global Quality Systems, Eli Lilly & Company

11:00 a.m. – 12:00 p.m. P8: Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System Moderator: Richard Friedman, Associate Director, OMPQ, CDER, FDA

Session Description: This session will focus on the ability of a company to drive continual improvement of the lifecycle of a product through a robust PPPQM system element. Using sound approaches in development form the basis for a quality product, however implementation of this PQS element captures the rich data and knowledge that is obtained throughout the lifecycle phases of tech transfer, commercial manufacturing, through product discontinuation. Topics will include traditional indicators such as batch data, deviations, complaints, CAPAs, and leading indicators such as the product steward model, evaluating quality across a global network and use of statistical tools. The opportunity exists to provide process capability measurements to have a true state of control in pharmaceutical manufacturing and support modern day approaches to lifecycle validation.

11:00 a.m. – 11:25 a.m.Product Quality Management Zena Kaufman, Senior Vice President, Global Quality, Hospira

11:25 a.m. – 11:45 a.m.Case Study: Use of Statistical Process Control Approaches to Detect Process Drift; Using Process Capability Measurement Industry Presenter Invited

11:45 a.m. – 12:00 p.m.Q&A /P7 & P8 Panel Discussion

12:00 p.m. – 1:00 p.m.Lunch


Tuesday, November 6, 2012 Agenda (continued)

General Informationof the Program Planning Committee

Three Ways to Register

1. Click www.pda.org/japanICHQ102. Fax +1 (301) 986-10933. Mail PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 150 Bethesda, MD 20814 USA

Venue

Keio Plaza Hotel TokyoContact: Mr. Tomoharu Kondo2-2-1 Nishi-Shinjuku, Shinjuku-Ku, Tokyo160-8330 JapanPhone: +1 81-3-5322-8060Fax: +1 81-3-3344-0247Website: http://www.keioplaza.com/

Rate: Single/Double: JPY 22,000 (Approximately $281.00) inclusive of tax, service charge, and breakfast.

Cut Off Date: Friday, September 28, 2012 (Rooms must be secured by this date in order to receive the PDA rate)

Conference Registration Hours

Monday, November 5, 2012: 7:00 am – 5:00pm Tuesday, November 6, 2012: 7:00 am – 5:00 pm

Dress/Attire

Business casual attire is recommended for the Pharmaceutical Quality System (ICH Q10) Conference. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

Special Requirements

If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to [email protected].

HHS has not endorsed any solicitations for this meeting. All donations have been applied exclusively towards defraying the expenses of non-Federal co-sponsors, not HHS. HHS is not asking for any funds in any capacity.

Contact Information

Conference inquiries: Wanda Neal, Sr. Vice President, Programs & Registration Services Phone: +1 (301) 656-5900 ext. 111 | E-mail: [email protected]

Registration inquiries: Tess Birch, Registration and Customer Accounts Phone: +1 (301) 656-5900 ext. 115 | E-mail: [email protected]

Sponsorship inquiries: David Hall, Vice President, Sales Phone: +1 (301) 760-7373 | Cell: +1 (240) 688-4405 | E-mail: [email protected]

P10: Change Management (continued)

3:15 p.m. – 3:45 p.m.Change Management: Enabling Quality ImprovementJaneen Skutnik-Wilkinson, Director, Quality and Regulatory Policy, Pfizer, Inc.

3:45 p.m. – 5:35 p.m. P11: Continual Improvement of the Pharmaceutical Quality SystemModerator: Richard Friedman, Associate Director, OMPQ, CDER, FDA

Session Description: Throughout the conference participants will have been shown how the key elements that make up a successful pharmaceutical quality system can be implemented in a practical way including continual improvement of products and processes. Once the pharmaceutical quality system is established it will need to be maintained and developed. The final session focuses on continual improvement of the pharmaceutical quality system itself. The session will show how the system contributes to its own improvement, and will include discussion of the internal and external factors that must be taken into account to keep the system fit for purpose.

3:45 p.m. – 4:15 p.m.The Importance of Continually Improving Your PQSMasatoshi Morisue, RPh, MSc, Director of GMP Inspection, Office of GMP/QMS Inspection, Pharmaceuticals and Medical Devices Agency (PMDA)

4:15 p.m. – 4:45 p.m.Case Study: How do You Know if Your PQS is a Healthy One?Zena Kaufman, Senior Vice President, Global Quality, Hospira

4:45 p.m. – 5:15 p.m.Complacency is not an OptionBarbara Mary Allen, Director Global Quality Systems, Eli Lilly & Company

5:15 p.m. – 5:35 p.m.Panel Discussion

5:35 p.m. – 5:45 p.m.Closing Remarks from Co-Chair of the Planning Committee Richard Friedman, Associate Director, OMPQ, CDER, FDA and, Co-Chair


Registration is simple and fast... Click, fax or mail: Click: www.pda.org/japanICHQ10 Fax: +1 (301) 986-1093 (USA); Mail: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA

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CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by September 6, 2012 your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are a non-member substituting for a member you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference/Events: If your written request is received on or before September 6, 2012 you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900. PHOTO RELEASE: By registering for Pharmaceutical Quality System (ICH Q10) Conference, I authorize PDA the right to photograph me and to use the photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

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Pharmaceutical Quality System (ICH Q10) ConferenceNovember 5-6, 2012 Keio Plaza Hotel | Tokyo, Japan

Sponsorship Opportunities are Available!

High impact, cost-effective sponsorship packages are available for thePharmaceutical Quality System (ICH Q10) Conference.

Comprehensive sponsorship packages will provide your company with the opportunity to strengthen brand image, increase visibility, and reinforce its commitment to the pharmaceutical industry. Sponsorships are available for lanyards, USBs, notepads, pens, refreshment breaks, lunch, and networking reception.

For more information about exhibit and sponsorship opportunities, please contact:David Hall, Vice President, Sales | Direct: +1 (301) 760-7373 | Cell: +1 (240) 688-4405 | E-mail: [email protected]

PDA Global Headquarters4350 East West HighwaySuite 150Bethesda, MD 20814 USAPhone: +1 (301) 656-5900Fax: +1 (301) 986-0296

Pharmaceutical Quality System (ICH Q10) ConferenceNovember 5-6, 2012 Keio Plaza Hotel Tokyo, Japan

www.pda.org/ japanICHQ10

Register By October 8, 2012 –

the Largest Registration Savings

Deadline!

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