Friday, October 6

8:00 Morning Coffee

8:30 Chairperson’s Remark

8:45 The Life Cycle of Quality and Compliance in Analytical Laboratories: Discovery, Development, Product Approval and Beyond
Dr. Nadine M. Ritter, Senior Consultant, Biologics Consulting Group, Inc.
The GLP and cGMP regulations define formal quality practices in laboratories conducting tests intended to be in alignment with these compliance requirements. However, there are a vast number of product studies done in laboratories that do not formally require either GLP or cGMP levels of compliance. Nonetheless, a minimum degree of basic quality practices are necessary when data generated in these laboratories are used to support regulatory filings or patent applications. This presentation will clarify the scope of GLP vs cGMP laboratory studies, and outline the basic quality practices recommended for implementation in all laboratories - whether academic, government, or industry - to assure the quality, integrity, and traceability of the data the produce.

9:25 Training: A Requirement for GMPs - But what is Adequate?
Ms. Dorothy Honda, Senior QA Specialist, deCODE Chemistry
What makes a good training program? What makes a training program that meets the demands of a cGMP regulated environment? In the past "read and understood" was the common mode of training, but today's employees must be able to credibly demonstrate an understanding of procedures to say that they are trained.
Decisions must be made to choose modes of training that are best-suited to subject matter. Technical training, compliance-related training, safety training, and general site information training - all of these modes have their place in organizations, but how should training coordinators balance these to create the most effective training programs?

10:05 Networking Coffee Break

10:40 GMP and Investigational Products in the EU - Considerations for a Vaccine at Phase 1
Dr. Cledwyn Davies, Manager, Product Quality & Regulatory Affairs, Health Protection Agency, Centre for Emergency Preparedness & Response, UK (tentatively)

11:20 Ensuring GMP Compliance for Combination Products
Mr. Shawn Cain, Vice President, Operations, Department of Manufacturing, Arbios Systems, Inc.
In this presentation, we will describe how combination product manufacturers can determine which regulations apply to different types of combination products. We will review several examples of manufacturing systems that combine features from both 21 CFR 820 and 21 CFR 210/211. We will further discuss challenges and approaches to ensure compliance in these complex manufacturing environments. Specifically, we will examine a case study using a combination medical device and biologic.

12:00 Disposable Bioreactor for GMP Manufacture of Biologics
Dr. Vijay Singh, President, R&D, Wave Biotech
This presentation will cover the rising usage of single-use bioreactors for the GMP production of human therapeutics. Validation, qualification, and commissioning issues with be addressed.

12:40 End of Conference