Biopharmaceutical QA/QC Strategy for Senior Management

Bethesda, MD
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products.

Biopharmaceutical QA/QC strategies will be examined incorporating science-based, risk-based and phase-appropriate considerations to address challenges from early clinical development through commercialization for recombinant proteins, monoclonal antibodies, genetically engineered viruses and human cells.

This course will provide insights and practical guidance for senior management in evaluating the effectiveness of their QA/QC strategy for biopharmaceuticals.

Who Should Attend

This course is for vice presidents, directors, managers and leaders in quality assurance/quality control, manufacturing, and regulatory affairs.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Oversee an effective and efficient quality risk managed strategy for your biopharmaceutical processes and products
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States

John Geigert, PhD, RAC, President, BioPharmaceutical Quality Solutions

John Geigert is President of BioPharmaceutical Quality Solutions, which for the last 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry. He has over 40 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe. John Geigert has served on the PDA Board of Directors, currently chairs the PDA Biopharmaceutical Advisory Board (BioAB), and has served as an expert member of the USP Biotechnology Committee. He is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics 2nd Edition, and has written extensively for RAPS Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series)), Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series). John Geigert obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.