Session P1: Applying Quality Risk Management in Sterile Manufacturing - Case Studies

Practical and novel approaches for applying Quality Risk Management are presented in case studies that explore the integration of ICH Q8, Q9, and Q10 to develop, implement and sustain a sterile drug product manufacturing control strategy and utilization of quantitative risk modeling to rapidly assess risk of bioburden ingress during aseptic filling.

Anne Renton, Quality Consultant, Parenteral Quality Assurance, Eli Lilly & Company
Edward Tidswell, PhD Senior Director, Research Sterility Assurance Technology Resources, Baxter Healthcare Corporation

Session P2: Contamination Control and Remediation

Persistent, intermittent low level bioburden recovery from water systems, product transfer piping and production skids may be indicative of biofilm formation.  In vitro models of biofilms can be used to provide valuable information regarding removal [treatment efficacy] of viable microbes.  Potential modalities for prevention of biofilm formation in sterile product processing equipment can also be studied. Treatment efficacy of biofilm in an in vitro biofilm model will be described.  In addition, biofilm mitigation strategy and results for sterile product processing equipment is provided in a detailed case study.

Mark Pasmore, PhD, Senior Principal Engineer, Baxter Healthcare Corporation
Richard Pettijohn, PhD, Staff Scientist, Pharmaceuticals Manufacturing Technology, Bayer HealthCare
Harold Baseman, Chief Operations Officer, ValSource LLC

Session P3: Application of PDA TR No.1 Sterilization Science Concepts

The development of a sterilization cycle needs to take into account several factors relating to the product and process.  During this recording, application of specific concepts taken from PDA TR No.1, using practical examples, are reviewed with a focus on applying these concepts to sterilizer cycle development tailored to a specific product type.

Michael Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare Corporation
Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting

Session P4: Evolving Novel Sterilization Technology

The use of new technologies for sterilization continues to evolve as product and packaging characteristics change.  This recording discusses several new approaches to sterilization and how they can be applied to commercial manufacturing.

Lisa Foster, Principal, Adiuvo QS & SA Consulting
David Opie, PhD, Vice President, R&D, Noxilizer, Inc.

Session P5: Case Studies on Risk Based Approaches for Sterile Product Facility Design

Risk to product quality and patient safety are essential considerations for the design of sterile manufacturing processes and facilities.  Risk based assessments and other related methodologies are tools, which can be used to identify key process variables, and help make decisions in an effort to design and operate more effective manufacturing facilities.  Case studies are presented on approaches used to plan, design, construct, qualify, and operate new sterile product manufacturing facilities utilizing risk based and innovative approaches focused on sterility assurance, including examples from bulk manufacturing, syringe and vial fill finish facilities.

Betty Hannoun, PhD, Technology Management Leader, Global Engineering Services, Merck Sharp & Dohme Corporation
Michael Kelliher, Associate Director, Project Management, Genzyme Corporation (Recording and handout are not authorized for distribution)

Session P6: Trends in Sterile Product Manufacturing Regulatory Expectations

Sterilization and aseptic processing are considered “special processes” since the output of these processes (product sterility) cannot be fully verified through subsequent sampling and testing.  Therefore, these manufacturing processes must be of robust design, rigorously controlled and properly validated.  This recorded session highlights the recent experiences from the complementary perspectives of an FDA Reviewer and an FDA Inspector to provide valuable insight into the regulatory expectations for the development, validation and ongoing control of sterile product manufacturing processes. 

John Metcalfe, PhD, Senior Microbiology Reviewer, New Drug Microbiology, CDER, FDA
Rebeca Rodriguez, National Drug Expert Investigator, ORA, FDA

Session P7: PDA Technical Report: Answers to your Sterile Product Questions

PDA Technical Reports cover a wide variety of subjects relating to pharmaceutical production, validation and quality assurance. These global consensus documents are prepared by member-driven Task Forces comprised of content experts including industry, regulatory and academic scientists and engineers. This recording highlights several technical reports which address areas important to sterile products, such as steam-in-place, dry heat sterilization, and process simulation for aseptically filled products, parametric release as well as an update on the revision of PDA TR No. 27 (container closure integrity).

Kevin Trupp, Principal Consultant, Sterilization Technology and Compliance
Deborah Havlik, Associate Director, R&D Microbiology, Hospira, Inc.
Harold Baseman, Chief Operations Officer, ValSource LLC
Richard V. Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA

Session P8: Ask the Experts Panel Discussion - The Future of Sterile Product Manufacture – Trends, Issues and Solutions

A member of the USP Packaging, Storage & Distribution Expert Committee discusses plans to revise <1207> Sterile Product Packaging Integrity.  A member of the USP Microbiology & Sterility Assurance Expert Committee provides highlights of important updates which serve to advance the microbial quality testing for the sterile product industry.

Presenters:

Diane Paskiet, Associate Director, Scientific Affairs, West Pharmaceuticals
Edward Tidswell, PhD,  Senior Director, Research Sterility Assurance Technology Resources, Baxter Healthcare Corporation

Panelists:

Harold Baseman, Chief Operations Officer, ValSource LLC
Betty Hannoun, PhD, Technology Management Leader, Global Engineering Services, Merck Sharp & Dohme Corporation
John Metcalfe, PhD, Senior Microbiology Reviewer, New Drug Microbiology, CDER,  FDA
Jeanne Moldenhauer, Consultant, Excellent Pharma Consulting
Diane Paskiet, Associate Director, Scientific Affairs, West Pharmaceuticals
Rebeca Rodriguez, National Drug Expert Investigator, ORA, FDA
Edward Tidswell, PhD,  Senior Director, Research Sterility Assurance Technology Resources, Baxter Healthcare Corporation

Contact

Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org