Agenda - Parenteral Drug Association

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Agenda

Sept 13Sept 14Sept 15Sept 16Sept 17Sept 18

Monday, September 14, 2009

7:00 a.m. – 6:00 p.m.
Registration Open

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

8:00 a.m. – 8:15 a.m.
Welcome/Opening Remarks

John Shabushnig, PhD, Senior Manager/Team Leader, Pfizer, Inc, and Chair, PDA Board of Directors
Richard M. Johnson, President, PDA
Richard Friedman, Director, Division of Manufacturing and Product Quality, CDER, FDA
Martin VanTrieste, Vice President of Quality and Commercial Operations, Amgen, Inc.
Co-chairs, 2009 PDA/FDA Joint Regulatory Conference Program Planning Committee

Opening Plenary Session
8:15 a.m. – 10:45 a.m.
Moderator: Martin VanTrieste, Vice President of Quality and Commercial Operations, Amgen, Inc. and Co-chair, 2009 PDA/FDA Joint Regulatory Conference Program Planning Committee

What will the year 2020 look like for the pharmaceutical industry and what challenges must be overcome for the pharmaceutical industry and specifically the manufacturing segment of the pharmaceutical industry to be successful?

8:15 a.m. – 8:45 a.m.
Keynote Presenter
FDA's Perspective
Joshua Sharfstein, MD, Deputy Commissioner, FDA

8:45 a.m. – 9:15 a.m.
Views on Public Policy as it Pertains to 2020
Jacqueline R. Scott, J.D., M.L., Senior Program Director, National Academy for State Health Policy

9:15 a.m. – 9:45 a.m.
Financial Analyst Perspective on the Pharmaceutical Industry
Barbara Ryan, Managing Director, Research Analyst, Deutsche Bank Securities, Inc

9:45 a.m. – 10:15 a.m.
A CEO's Pespective
Michael W. Bonney, President and CEO, Cubist Pharmaceuticals, Inc.

10:15 a.m. – 10:45 a.m.
Question & Answer

10:45 a.m. – 11:30 a.m.
Grand Opening of Exhibit Area and Refreshment Break

Plenary Session 2 – Effective Pharmaceutical Quality Systems
11:30 a.m. – 1:00 p.m.
Moderator: Steve Mahoney, Attorney at Law, Hogan and Hartson, LLP

What's the current state of pharmaceutical quality systems? Hear FDA and industry experts discuss the importance of establishing, implementing and maintaining an effective pharmaceutical quality system throughout the drug product lifecycle.

11:30 a.m. – 12:00 p.m.
Management Responsibility: How it Made us More Compliant and Efficient
Swroop Sahota, PhD, Vice President, Global Quality Services, Schering-Plough Corporation

12:00 p.m. – 12:30 p.m.
International Working Group: The Path Forward
Stephan Roenninger, Global Quality Manager, F. Hoffmann-La Roche, Ltd.

12:30 p.m. – 1:00 p.m.
A Regulatory Perspective
Joseph Famulare, Deputy Director, CDER, FDA

1:00 p.m. – 2:00 p.m.
Lunch on your own
Regulatory Affairs and Quality Committee (RAQC) Meeting

2:15 p.m. – 5:00 p.m.
Science Advisory Board (SAB) Meeting

2:00 p.m. – 4:00 p.m.
Concurrent Sessions

Quality Systems

A1: Management Review

Moderator: Marsha Major, Director, Quality and Compliance, Johnson & Johnson Corporate

Quality is not and cannot be the sole responsibility of the Quality Unit. An effective enterprise wide Pharmaceutical Quality System requires the visible commitment of management. Learn FDA expectations of Sr. Management and hear experiences and best practices from industry Sr. Management

2:00 p.m. – 2:30 p.m.
FDA Expectations
David Jaworski, Consumer Safety Officer, Division of Manufacturing and Product Quality, CDER, FDA

2:30 pm – 3:00 pm
Applications
Kirk Huber, Executive Director of Regulatory Compliance, Novartis

3:00 pm- 3:30 pm
Case Study
Shane Killian, Sr., Sr. Analyst, Johnson & Johnson Pharmaceutical Supply Chain

3:30 p.m. – 4:00 p.m.
Question & Answer

Supply Chain

B1: Quality Agreements/Technical Agreements/Cooperative Agreements

Moderator: Martyn Becker, President, Martyn Becker Associates

When working with contract manufacturers, Quality Agreements/Technical Agreements/Cooperative Agreements are critical to clarify and document the responsibilities and expectations between the contract giver/license holder and contract acceptor/CMO regarding quality aspects of the outsourced activity. Understanding the underlying purpose of a Quality Agreement clarifies the functional and quality aspects of a business relationship. It defines, in significant detail, the responsibilities of quality, regulatory and production personnel within each company and improves communication. Learn the key elements and the FDA’s regulatory requirements and expectations for a quality agreement to avoid surprises and misunderstandings that could result in regulatory issues or work of unacceptable quality. Industry and contractor application and case study presentations will corroborate and provide practical advice for complying with FDA requirements for quality agreements

2:00 p.m. – 2:30 p.m.
FDA Expectations
John Eltermann, Jr., Director, Division of Manufacturing and Product Quality, CBER, FDA

2:30 pm – 3:00 pm
Applications
Barbara Zinck, President, Zinck Consulting

3:00 p.m.- 3:30 p.m.
Case Study: Standardized Agreements
James Shirey, Director/Team Leader of Contract Operations Quality Assurance, Pfizer, Inc.

3:30 p.m. – 4:00 p.m.
Question & Answer

Hot Topics

C1: Product Containment

Moderator: Louise Johnson, Senior Vice President, Aptuit

Product containment is a critical element of a firm's quality system that spans product on boarding through distribution, and involves a significant number of functional departments. Having a holistic approach to the design and execution of product containment is a critical success factor. In this session regulatory and industry leaders will discuss key aspects of product containment, including best practices and learning points.

2:00 p.m. – 2:30 p.m.
Regulatory Expectations
Nancy Waites, Biologist, CBER, FDA

2:30 pm – 3:00 pm
Applications and Case Study
James Skrine, Executive Director/Site Head, Quality, Amgen, Inc.

3:00 p.m.- 3:30 p.m.
Applications and Case Study
Nigel Hamilton, Quality Director, Sanofi-Aventis

3:30 p.m. – 4:00 p.m.
Panel Discussion/Q & A
Edwin Melendez, Consumer Safety Officer, CDER, FDA

4:00 p.m. – 4:30 p.m.
Refreshment Break in Exhibit Area

4:30 p.m. – 6:00 p.m.
Concurrent PDA Interest Group Sessions

IG1: Biotechnology Interest Group	IG2: Packaging Science Interest Group	IG3: Filtration and Pharmaceutical Water Interest Groups	IG4: Clinical Trial Materials Interest Group	IG5: Facilities and Engineering Interest Group	IG6: Quality Systems Interest Group
IG Leader: Jill A. Myers, PhD, President, BioPro Consulting	IG Leaders: Edward J. Smith, PhD, Principal Consultant, Packaging Science Resources	IG Leaders: Russell E. Madsen, President, The Williamsburg Group and Theodore H. Meltzer, PhD, Consultant, Capitola Consulting	IG Leader: Vince L. Mathews, Quality Assurance Consultant, Eli Lilly and Company	IG Leader: Christopher J. Smalley, PhD, Director, Global Compliance Operations, Wyeth Pharmaceuticals	IG Leader: Anders Vinther, PhD, Senior Director, Quality Operations, Genentech
The Biotechnology Interest Group provides a forum for technological, regulatory and educational discussions with the challenges facing the biotechnology sector of the industry, including use of recombinant organisms, novel biochemical, technological and regulatory approaches in bringing biotechnology based products to the public. The Biotechnology Interest Group meets the mission of PDA of advancing understanding of existing and cutting edge biotechnology internationally by promoting scientifically sound, practical technical information and education for industry and regulatory agencies. The topic for discussion during this session is “Case Studies from the Pilot QBD Program.”	The PDA Packaging Science Interest Group (PSIG) meetings are open to all those with an interest in the impact of packaging on drug and medical device products. The agenda for the meeting will include an overview of the current and proposed USP packaging-related chapters, and a report on the USP’s proposal on Caps & Overseals in General Chapter 1. This proposal affects all products packaged in vials with a rubber closure. The third presentation will review the certification of sterility of pre-sterilized packaging components obtained by a pharmaceutical company from a supplier. Other topics will be discussed as time permits.	The PDA Filtration Interest Group provides a forum for discussion of topics and issues related to filtration in pharmaceutical and biopharmaceutical applications, including sterilizing filtration of liquids and gases, depth filtration of process streams and process systems, and viral removal and purification. Discussions are held in conjunction with PDA meetings (e.g., the Annual Meeting and PDA/FDA Joint Conference).	The Clinical Trial Materials Interest Group offers members an opportunity to discuss topics of interest associated with the development and manufacture of clinical supplies. This includes the pre-clinical phase (involving pharmaceutical development operations), the manufacture of all phases of clinical supplies (including both API and drug product), and the ultimate transfer of the manufacturing process to the commercial manufacturing site. This group offers a valuable opportunity to interact with professionals and regulators alike to share ideas, discuss opinions, and offer advice to each other in this very complex area of the pharmaceutical business. When deemed appropriate by the group, position papers may be drafted and feedback on proposed regulations may be given. Karen Migliaccio (Migliaccio Consulting, LLC) will be the featured speaker for this session, presenting on “Quality Systems in R&D: How ICH Q8/Q9/Q10 Fit Together.”	The primary focus of the Facilities & Engineering Interest Group will be on “Predictive Maintenance,” featuring Greg Walker of Wyeth Pharmaceuticals. Predictive Maintenance (PdM) utilizes technologies such as vibration analysis, thermal imaging, ultrasonics, oil analysis, laser alignment and dynamic machinery balancing to predict the ability of the facility to meet future production within time, quality and cost commitments by supplying knowledge of equipment operating problems. By anticipating or warning of failure, equipment utilization is increased by resolving issues before they become catastrophic to the equipment, and likely the product.	The PDA Quality Systems Interest Group is a network of QA/QC professionals. Past topics have dealt with diverse subjects ranging from Systems Based Inspections, to QA /QC Organizations, to Risk Analysis. The Quality Systems Interest Group also sponsors a Quality Systems Forum on the PDA Web site for daily networking opportunities. Members participate in Task Forces on Compliance and Quality related topics.
Speaker: Case Studies from the Pilot QBD Program Stephen Notarnicola, Biogen Idec Quality by Design Duncan Low, Amgen	Speaker: “Certification of Sterilization for Pharmaceutical Packaging Components” Robert S. Nase, West Pharmaceutical Services “Status Update on USP General Chapter 1 – Caps & Overseals” Deborah M. Thomas, West Pharmaceutical Services “Recent Changes in USP Packaging Chapters” Desmond G. Hunt, PhD, United States Pharmacopeial Convention	Speaker: Sei-ichi Manabe, Sepa-Sigma, Inc.	Speaker: Karen Migliaccio, Migliaccio Consulting, LLC	Speaker: Greg Walker, Wyeth Pharmaceuticals	Speaker: Tara Gooen, MS, CDER, FDA

6:00 p.m. – 7:30 p.m.
Networking Reception in Exhibit Area

Top

Tuesday, September 15, 2009

7:00 a.m. – 6:00 p.m.
Registration Open

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

7:15 a.m. – 8:15 a.m.
Concurrent PDA Interest Group and Breakfast Sessions (Choose from 6 sessions)

Breakfast Session I IG7: Vaccines Interest Group	Breakfast Session II IG8: Pre-Filled Syringes Interest Group	Breafast Session III IG9: Sterile Processing and Lyophilization Interest Groups (combined session)
IG Leader: Frank S. Kohn, PhD, President, FSK Associates, Inc.	IG Leader: Thomas Schoenknecht, PhD, Director, Drug Product and Device, Amgen, Inc.	IG Leaders: Richard M. Johnson, Consultant, RMJ Consulting and Edward H. Trappler, President, Lyophilization Technology, Inc.
The Vaccines Interest Group (VIG) focuses on issues that affect the biological, biotechnology, and vaccine industry. The interest group has previously discussed regulatory issues, new technologies, and emerging industry trends. Resent issues include vaccine availability and supplies, homeland security, and inspection trends. The group also issues a newletter (VIG). All PDA members are welcome to attend VIG meetings, which are held in conjunction with PDA events.	The Pre-filled Syringe Interest Group provides a forum for discussions of actual topics related to prefillable injection system components such as cartridges or syringes and combinations thereof with injection and safety devices. Members come together to exchange in an open discussion latest information about technological improvements in the universe of prefillable syringes and injection devices, covering production, filling, handling and regulatory aspects. The format of the Interest Group meetings includes formal presentations of experts from industry and government as well as open discussion forums and preparation of upcoming conferences to related topics.	The session will begin with an Introduction and review of ISO 13408-3 Lyophilization of Health Care Products, followed by an open forum on Process Simulation Media Fill, with focus on lyophilized products. Active participation on approaches to conducting Process Simulation Media Fills for lyophilized products is encouraged.
Speaker: Anthony Luttrell, Raland Technology	Speakers: Pharma Perspective Eric Berg, Amgen, Inc. Improvement activities at Gerresheimer (Kimble) for syringes and vials Klaus Wuttke, Gerresheimer Improvement activities at Nuova Ompi for vial and syringe production Howard Drake, Ompi of America Improvements from Schott perspective and featuring Japan quality Christian Helbig, Schott

Breakfast Session IV	Breakfast Session V	Breakfast Session VI
Ask the FDA about Regulated Products and Standards	"Ask CDER Compliance"	Knowledge Management and PAT
Moderator: David Cummings, OPS Quality System Manager ASQ Certified Manager of Quality/Organizational Excellence ASQ Certified Quality Auditor, CDER, FDA	Moderator: Brian Hasselbalch, Team Leader, Guidance and Policy Development Team, CDER, FDA	Moderator: Vince Mathews, Quality Assurance Consultant, Eli Lilly & Company
There are many definitions for the term standard. The American Society for Quality defines a standard as the metric, specification, gauge, statement, category, segment, grouping, behavior, event or physical product sample against which the outputs of a process are compared and declared acceptable or unacceptable. The White House Office of Management and Budget defines a standard, in part, as common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. FDA regulated products (e.g., biologics, drugs, devices, and combination products) are impacted by a number of different types of standards, including voluntary and consensus standards. This session will address standards employed by FDA and industry and provide for dialogue on standards development opportunities and application for products regulated by CBER, CDER, CVM and CDRH.	Attendees will hear from FDA technical and team leaders on specific topics during a panel discussion that will be open for questions from the conference participants. This breakfast session will provide an excellent opportunity to listen to and directly interact with leaders in the regulatory community on subjects of importance to the pharmaceutical and biopharmaceutical industry.	This session will provide a practical understanding of exploring the potential use and implementation of PAT during the product lifecycle. We will discuss the selection and installation of PAT equipment, utilization of PAT R&D data collected during GMP processing, approaches for analyzing the multitude of data that is collected, and utilization of PAT information during processing. A thought-provoking case study will be presented to demonstrate its implementation. Lessons learned and discussions will play a major role. Although the groundwork has been laid, there are still more questions than answers on how to successfully implement these initiatives. This session will provide potential solutions and facilitate a discussion on best practices.
FDA Perspective on Standards for Regulated Products Jon Clark, Associate Director For Policy, CDER, FDA Panel: Christy Foreman, Deputy Director in the Office of Device Evaluation, CDRH, FDA Charles O’Brien, PhD,Team Leader with the Division of Manufacturing Technologies, CVM, FDA Christopher Joneckis, PhD,Senior Advisor for CMC Issues, Office of the Center Director, CBER, FDA	Panel: "Pre-Approval Issues" Tara Gooen, MS, CDER, FDA "Process Validation" Grace McNally, CDER, FDA "PAT" Vibhakar Shah, CDER, FDA	Wallace Torres, QuaSaR Program Leader, Hoffman-La Roche Inc. Paolomi Mukherji, Manger, Clarkston Consulting

Plenary Session 3 – Pharmaceutical Safety and Good Distribution Practices
8:30 a.m. – 10:30 a.m.
Moderator: Kathleen Greene, Executive Director, Novartis Pharmaceuticals

Is that tablet you are putting in your mouth the real thing or is it a combination of blue road paint, starch and glue? Learn how fragile the global supply chain is and the extent of the counterfeiting problem. Nearly every manufactured product has components from several different countries. Hear industry and regulatory experts discuss current global initiatives and examples of ways to mitigate the problem and how transparency of the supply chain can be achieved.

8:30 a.m. – 9:00 a.m.
The Dark Trade
Katherine Eban, Independent Journalist and Author

9:00 a.m. – 9:30 a.m.
The Current and Emerging Regulations
Edwin Rivera-Martinez, Chief, Manufacturing Assessment and Pre-approval Compliance Branch, Office of Compliance, CDER, FDA

9:30 a.m. – 10:00 a.m.
Janeen Skutnik, Director, Quality and Regulatory Policy, Pfizer, Inc
Eric Berg, Director of Supplier Quality, Amgen, Inc.

10:00 – 10:30 am
Andrew Jackson, Vice President of Corporate Communication and Aviation, Novartis

9:00 a.m. – 10:00 a.m.
Validation of Manual Aseptic Processes Task Force Meeting

10:00 a.m. – 12:00 p.m.
Early Phase Clinical Trial Materials Task Force Meeting

10:30 a.m. – 4:00 p.m.
Exhibit Hall Open

10:30 a.m. – 11:00 a.m.
Refreshment Break in Exhibit Hall

11:00 a.m. – 1:00 p.m.
Concurrent Sessions

Quality Systems

A2: CAPA

Moderator:
Laurie Norwood, Deputy Director, Division of Manufacturing and Product Quality Office of Compliance and Biologics Quality, CBER, FDA

Corrective actions and preventive actions are important elements of any organization's Quality System. These activities impact the drug product manufacturer's ability to eliminate or reduce the risk of failure to meet the customer's expectations and established product requirements. Industry and regulatory experts will share their knowledge and learning gained through the regulatory approval process and the operational activities defined in the Pharmaceutical Quality System framework. This session will address: product planning, product improvement, product control, and change management as they relate to corrective actions and preventive actions.

11:00 a.m. – 11:30 a.m.
FDA Expectations
Kim Trautman, Medical Device Quality Systems/GMP Expert, CDRH, FDA

11:30 a.m. – 12:00 p.m.
Applications
Marsha Major, Director, Quality and Compliance, Johnson & Johnson Corporate

12:00 p.m. – 12:30 p.m.
Case Study: How CAPA Has Evolved in Biotech
Martin VanTrieste, Vice President of Quality; Commercial Operations, Amgen, Inc. and Co-chair, 2009 PDA/FDA Joint Regulatory Conference Program Planning Committee

12:30 p.m. – 1:00 p.m.
Question & Answer

Supply Chain

B2: Technology Transfer

Moderator:
Mai Huynh, Supervisory Team Leader, Division of Manufacturing Technologies, CVM, FDA

Transferring product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve the desired state where product and process can be manufactured at commercial scale can be a challenge. Achieving a desired state begins with sharing a knowledge base which begins in research and development and continues through technology transfer and commercial manufacturing.

While a lot of progress has been made in the last decade towards achieving improved understanding of pharmaceutical processes via incorporation of elements of the Process Analytical Technology (PAT) and Quality by Design (QbD), problems are still encountered when performing transfer and scale up activities. This session will focus on issues associated with product/process complexities, specifically with biotech and small molecule products.

11:00 a.m. – 11:30 a.m.
FDA Expectations
Steven Wolfgang, PhD, Consumer Safety Officer, CDER, FDA

11:30 a.m. – 12:00 p.m.
Applications
Thomas Friedli, PhD, Managing Director Tectem, University of St. Gallen, Switzerland

12:00 p.m. – 12:30 p.m.
Case Study
Anurag Rathore, Director, Indian Institute of Technology, Delhi

12:30 p.m. – 1:00 p.m.
Question & Answer

Hot Topics

C2: Continual Improvement

Moderator:
John Finkbohner, Director, Regulatory Affairs/Vaccines, MedImmune, Inc.

This session will seek to provide an update on the FDA considerations around continuous improvement and share the experiences of organizations who have implemented such systems in manufacturing. Optimizing process capability through continuous improvement requires management support, both philosophically and financially. The continuous learning that arises from production experience provides product and process understanding so that: appropriate risk models can be optimized; potential weaknesses can be identified and controlled; timely remediation can be made when deviations occur; product quality can be efficiently assessed through ongoing analyses; and, science-based approaches can lead to decision-making based on an understanding of intended product use. As a long term goal, manufacturers with appropriate process knowledge and a robust quality system should be able to implement many types of improvements without the need for prior regulatory filing. In addition, an effective quality system may decrease the length and frequency of inspection coverage by lowering the risk of manufacturing problems.

11:00 a.m. – 11:30 a.m.
FDA Expectations
Robert Sausville, Director of Case Management, CBER, FDA

11:30 a.m. – 12:00 p.m.
Applications
Victor Yamauchi, Director of Supplier Quality, Amgen, Inc.

12:00 p.m. – 12:30 p.m.
Case Study
Ian See, Senior Director, Operational Excellence, MedImmune

12:30 p.m. – 1:00 p.m.
Question & Answer

1:00 p.m. – 2:00 p.m.
Lunch on your own – Exhibit Hall Closed
Interest Group Leaders Meeting

1:00 p.m. – 2:45 p.m.
Biotechnology Advisory Board Meeting

2:00 pm – 3:30 pm
Concurrent Sessions

Quality Systems

A3: Change Management

Moderator: Maria Guazzaroni –Jacobs, Director/Team Leader – Regulatory Monitoring – Quality Operations, Pfizer, Inc

All post approval planned permanent changes that have the potential to impact regulatory filings or the quality of active pharmaceutical ingredients, drug products, medical devices, or biological products are evaluated, reviewed, and approved by the firm, and depending on the change, by the agency. The FDA guidances include recommendations on reporting categories for post approval changes. This session will discuss the FDA expectations on change management and industry will present case studies.

2:00 p.m. – 2:30 p.m.
FDA Expectations
Richard Friedman, Director, Division of Manufacturing and Product Quality, CDER, FDA and Co-chair, 2009 PDA/FDA Joint Regulatory Conference Program Planning Committee

2:30 p.m. – 3:00 p.m.
Applications
Sue Schniepp, Vice President, Quality Assurance, Javelin Pharmaceuticals

3:00 p.m. – 3:30 p.m.
Case Study
Richard Norgard, Executive Director, Pfizer, Inc.

Supply Chain

B3: Supplier Qualification: Auditing/Products and Services

Moderator: Paul Allen, Vice President, Managing Partner Life Sciences, Clarkston Consulting

The reality of a globalization in the pharmaceutical industry is now having a profound impact on various points along the supply chain. Recent activities have highlighted how critical it is becoming to establish standards for suppliers into the manufacturing process. Meeting stricter client and international quality management standards requires some vendors to invest in improving practices, policies and management systems. Aligning those standards and validating them for compliance with multiple vendors impacting many product lines has resulted in an extremely complex matrix of tracking systems. Supporting these activities with an acceptable technology platform and building the setting where data can be accessed and shared is critical to establishing an effective strategy. In this session we will hear real-life case studies on lessons learned and best practices to apply.

2:00 p.m. – 2:30 p.m.
FDA Expectations
Steven Wolfgang, PhD, Consumer Safety Officer, CDER, FDA

2:30 pm – 3:00 pm
Applications: RX360
Eric Berg, Director of Supplier Quality, Amgen, Inc.

3:00 p.m.– 3:30 p.m.
Case Study
Gerard Pearce, Vice President, SQA

Hot Topics

C3: Recall Root Causes

Moderator: Elizabeth Leininger, PhD, Regulatory Affairs and Quality Consultant, Elizabeth Leininger Consulting

In 2008, CDER initiated a research project to determine root causes for Class I and Class II recalls. The goal of this session is to present FDA's findings of a retrospective analysis of the most serious (Class I) recalls, find out about how proactive mistake proofing (Poka Yoke) identifies mistakes and achieves corrections through five remediation strategies. Finally, other modern approaches to prevent recalls will be addressed by learning from past failures, and through a total quality orientation, cause and effects matrix, and isolation of the root causes.

2:00 pm – 2:30 pm
FDA Expectations:
Drill Downs of the Mechanistic Causes of Failures/Product Defects Latest Findings
Lynn Torbeck, Statistician, Torbeck and Associates

2:30 p.m. – 3:00 p.m.
Applications: Good Practices for Failure Root Cause Determination
Wayne Taylor, PhD, Chairman, Taylor Enterprises

3:00 p.m. – 3:30 p.m.
Case Study: "Near Misses in the Pharmaceutical Industry"
Ulku Oktem, PhD, Adjunct Professor, Operations and Information Management Department, Wharton School of the University of Pennsylvania

3:30 p.m. – 4:00 p.m.
Refreshment Break in Exhibit Hall

4:00 p.m. – 5:45 p.m.
Concurrent Sessions

Quality Systems

A4: Knowledge Management

Moderator: Stephan Roenninger, Global Quality Director, F. Hoffmann-La Roche, Ltd.

Beside Quality Risk Management Knowledge Management is an enabler for the Pharmaceutical Quality System according to ICH Q10. It is defined as: ‘Systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components’. As consequence the information gained from data is brought into a framework to support a risk based rationale for continual improvement. It is also important that knowledge is available not only in documentation (e.g. submissions, sop) but also to appropriate personnel, unit(s), companies and/or contractors in order to support risk based decisions.
The presentations during this session will describe the views from FDA which includes the current thinking at the ICH Quality Implementation Working group (Q-IWG). Tools, expertise and resources will be devoted to implement Knowledge Management as enabler into applications. The case study will explain an implementation in a company with global environment.

4:00 p.m. - 4:30 p.m.
FDA Expectations
Joseph Famulare, Deputy Director, CDER, FDA

4:30 p.m. – 5:00 p.m.
Applications
Lothar Hartmann, PhD, Head of External Relations, F. Hoffmann- La Roche, Ltd.

5:00 p.m. – 5:30 p.m.
Case Study
Frank Voehl, Chairman and CEO, Strategy Associates

5:30 p.m. – 5:45 p.m.
Question & Answer

Supply Chain

B4: Good Distribution Practices and Good Importer Practices

Moderator: Peggy Rooks, Director of the Center of Excellence, Abbott Laboratories

Distribution and importation activities can have significant impact on product safety and efficacy. This session will recap the current FDA expectations in this area, discuss the Qualified Trusted Importer Program (QTIP) and share examples of improvements in distribution practices resulting from the implementation of Good Distribution Practices (GDP's).

4:00 p.m. - 4:30 p.m.
Huascar Batista, Consumer Safety Officer, CDER, FDA

4:30 p.m. – 5:00 p.m.
Applications
James Shirey, Director/Team Leader of Contract Operations Quality Assurance, Pfizer

5:00 p.m. – 5:30 p.m.
Case Study
David Ulrich, Director, Quality Assurance, Abbott

5:30 p.m. – 5:45 p.m.
Question & Answer

Hot Topics

C4: Standard Development

Moderator: Paul Balcer, Special Assistant, Division of Product Quality and Manufacuring, CDER, FDA

There are a number of different standards that are relevant to the pharmaceutical indusrty. These include process standards (ANSI, ASTM, ISO), market standards for product quality (USP) and packaging standards (ISO). This session will explore some notable ISO 9000 family of international quality management standards, in particular ISO 9001 which specifies a basic quality management system (QMS) approach for an organization to show its ability to consistently offer products that meet the customers needs. The session will also inform the audience on IPEC’s plans to have their GMP Guide for Pharmaceutical Excipients considered for acceptance by an accredited standard setting organization.

4:00 p.m. - 4:30 p.m.
FDA Expectations/ Applications
Jon Clark, Associate Director for Policy, CDER, FDA

4:30 p.m. – 5:00 p.m.
Applications
Betsy Fritschel, Director, Quality & Compliance Services, Johnson & Johnson

5:00 p.m. – 5:30 p.m.
Case Study: IPEC/IPAC
Janeen Skutnik, Director, Quality and Regulatory Policy, Pfizer, Inc.

5:30 p.m. – 5:45 p.m.
Question & Answer

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Wednesday, September 16, 2009

7:00 a.m. – 12:00 p.m.
Registration Open

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

7:15 a.m. – 8:15 a.m.
Concurrent Breakfast Sessions

Breakfast Session VI IG10: Process Validation and Quality Risk Management Interest Groups (combined session)	Breakfast Session VII IG11: Combination Products Interest Group
IG Leaders: Mike Long, Director, KMP Int. Associates Jeffrey Hartman, IV, Validation Manager, Merck & Co., Inc. Scott Bozzone, Senior Manager, Global QO Validation, Pfizer, Inc.	IG Leader: Michael A. Gross, PhD, Principal Consultant, Chimera Consulting
To provide an on-going forum for the exchange and dissemination of information and ideas for the purpose of education, innovation, and compliance related to the validation of critical processes and those activities which support the validation of critical processes. The interest group should be a forum for presenting and discussing issues and trends in validation. These discussions should result in a better understanding of PDA member needs. This in turn results in better programs, more useful publications, and appropriate areas of advocacy. The Process Validation and the Quality Risk Management Interest Groups will combine to discuss the following initiatives: (1) Brief Updates on both the PV and RM Interest Groups (2) A Risk Management Case Study - Speaker Wallace Torres (3) Panel Discussion on FDA's new Process Validation Guidance document- Panelists Christopher Joneckis & Michael Popek	This meeting will feature a presentation by a representative of FDA’s Office of Combination Products (OCP) on the fundamentals of the regulation of combination products. The presentation will serve as a refresher for those who are experienced in combination products and as an introduction to combination products for those who are not. It is provided in preparation for discussions on advanced topics that will be presented during the Combination Product Conference which immediately follows the PDA-FDA Joint Regulatory Conference.
Speaker: Wallace Torres, QuaSaR Program Leader, Hoffman-La Roche, Inc. Panel: Michael Popek, Center for Veterinary Medicine, FDA Christopher Joneckis, PhD, Office of the Center Director, FDA CBER	Speaker: Patricia Y. Love, MD, Deputy Director, Office of Combination Products, FDA

Breakfast Session VIII IG12: The Visual Inspection of Parenterals Interest Group	Breakfast Session X A Closer Look at Recent Trends in Manufacturing; Shifting to Disposables
IG Leader: John G. Shabushnig, PhD, Senior Manager, Global Quality Operations, Pfizer, Inc	Moderator: Laurie Norwood, Deputy Director, Division of Manufacturing and Product Quality Office of Compliance and Biologics Quality, FDA
The Visual Inspection of Parenterals Interest Group provides a forum to discuss topics related to the visual inspection of injectable products. A brief update on recent regulatory activity in the area will be presented. This will be followed by a discussion on topics of interest as chosen by those in attendance. Past topics have included selection and qualification of human inspectors, validation of automated inspection systems, inspection of difficult products or packages and country specific inspection.	This session will explore the trend to move from traditional manufacturing product contact equipment to the use of disposables in effort to reduce risk of cross contamination as well as costs associated with cleaning validation. Traditional product contact equipment used in the manufacture of legacy biologics include transfer piping, vessels and/or bulk tanks. Some manufacturers are seeking to migrate toward disposable transfer tubing, bags and even column resins in lieu current equipment that is required to be cleaned, sanitized and or sterilized. These case studies will include examples from the cell and gene therapy arena as well as traditional products. Can disposable technologies offer benefits that help manufacturers streamline operations and shorten processing times?
	Speaker: Rabia Ballica, PhD, Product/CMC Reviewer, CBER, FDA

Plenary Session 4 – A Patient's Perspective
8:30 a.m. – 8:50 a.m.
Moderator: Robert Dana, Senior Vice President, Quality and Regulatory Affairs and PDA Training and Research Institute, PDA

Sometimes as we do our daily jobs it is easy to forget the ultimate goal of our companies which is to make safe and effective pharmaceutical products for patients. Patients who have benefited from our efforts will help us focus on our mission by expressing how our products have helped to save their lives.

Speaker: Malcolm Holmes, formerly with GSK

Plenary Session 5 – FDA Center Directors Expectations Going Forward
8:50 a.m. – 10:25 a.m.
Moderator: Robert Dana, Senior Vice President, Quality and Regulatory Affairs and PDA Training and Research Institute, PDA

This session will provide the Directors of the FDA's Centers for Biologics, Drugs, Medical Devices and Veterinary Medicine, as well as the Office of Regulatory Affairs, to make brief presentations on topics of current and future interest in each of their respective organizations. They will be invited to share the status of the various initiatives underway, as well as describing any concerns associated with the completion of these initiatives. Following presentations by the Directors, they will participate in an interactive panel discussion, responding to questions from the Conference attendees. Don't miss this opportunity to hear directly from senior FDA management about the latest hot topics potentially affecting you and your company. Come prepared with your questions!

Panel on Center Initiatives and Q & A

Dennis Bensley, PhD, Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM, FDA
Christopher Joneckis, PhD, Senior Advisor for CMC Issues, Office of the Center Director, CBER, FDA
Jonathan Sackner-Bernstein, MD, Associate Center Director for Post Market Operations, CDRH, FDA
Janet Woodcock, MD, Director, CDER, FDA

10:25 a.m. – 10:40 a.m.
Refreshment Break

Plenary Session 6 – A Patient's Perspective
10:40 a.m. – 11:00 a.m.
Moderator: Sue Schniepp, Vice President, Quality Assurance, Javelin Pharmaceuticals

Speaker: Amy Giertych, Senior Director, Global RA, Baxter

Plenary Session 7 – FDA Compliance Expectations Going Forward
11:00 a.m. – 12:00 p.m.
Moderator: Sue Schniepp, Vice President, Quality Assurance, Javelin Pharmaceuticals

In this session we will hear directly from some of the agency's leaders with regard to current and future compliance initiatives. By understanding the direction the agency is headed we can prepare for these initiatives thereby being able to continue to provide safe and effective medicine to our patients.

Panel on Center Initiatives and Q & A

Joseph C. Famulare, Deputy Director, CDER, FDA
Richard Friedman, Director, Division of Manufacturing and Product Quality, CDER, FDA
Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
Martine Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance, CVM, FDA
Timothy Ulatowski, Director, Office of Compliance, CDRH, FDA
Doug Stern, Director, Division of Compliance Policy, ORA/OE, FDA

12:00 p.m. – 12:15 p.m.
Closing Remarks
Richard Friedman, Director, Division of Manufacturing and Product Quality, CDER, FDA
Martin Van Trieste, Vice President of Quality and Commercial Operations, Amgen, Inc.
Co-chairs, 2009 PDA/FDA Joint Regulatory Conference Program Planning Committee

12:15 p.m. – 1:15 p.m.
Phase Appropriation of GMP's Task Force Meeting

1:00 p.m. - 4:45 p.m.
Assessing Risks of Changing Sterile Drug Manufacturing Sites Workshop

1:00 p.m. - 6:00 p.m.
PDA Combination Products Workshop

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