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GlobalCompliancePanel, Online Training Webinar
2010-10-07
Cell line development followed by preparation of the master/working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to be adequate and appropriate for commercial production, causing product approval delays and rejections. Why should you attend: 'Secret', according to Merriam-Webster's dictionary, is 'something kept hidden or unexplained.' A variety of reasons why an effective Chemistry Manufacturing & Controls (CMC) regulatory strategy for biopharmaceuticals can be a secret: (1) job security, especially for regulatory affairs personnel and project managers who master the strategy; (2) the infamous proprietary defense, divulging this strategy only to those within one’s own company or group, i.e., the initiated; and (3) not being aware that an effective strategy can be at hand. Insight and practical suggestions into a common sense business approach to develop and manage an effective CMC regulatory strategy for biopharmaceuticals will be provided in a multi-part series. Part 1 discusses the critical importance of the cell banks for biopharmaceuticals. Areas Covered in the Session: - Regulatory definition of biopharmaceutical starting material
- Common cell lines chosen for biopharmaceutical production
- Issue of clonality
- Clinical phase-dependent regulatory requirements of recombinant cell banks
- Pros/cons of changing cell banks during clinical development
- Issue of inadequate documentation for preparation of the master cell bank
- Critical importance of an effective CMC strategy for cell banks - lessons learned from product approval delays and rejections
Who will benefit:This course is designed for managers, supervisors, project planners and professional staff who develop or implement the Chemistry, Manufacturing & Controls (CMC) regulatory strategy for biopharmaceutical products. - Project Management
- Regulatory Affairs
- Manufacturing
- Quality Assurance
- Quality Control
- Process Development
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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John Geigert, Ph.D., RAC, President, BioPharmaceutical Quality Solutions, a consultant for the past 10 years specializing in CMC regulatory strategy for the biopharmaceutical industry.
Dr. Geigert has held senior leadership positions in industry as Vice President of Quality for both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and as Director of Quality Control for Cetus Corporation in Emeryville, CA. He obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.
Dr. Geigert has been a major participant in CMC regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe, and has over 30 years of experience in the biopharmaceutical industry. He is author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, Plenum Press, New York (2004) and has written articles for RAPS, What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products; 4-part series in RAPS Focus; Aug-Nov 2009.
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Deadline for Abstracts:
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2010-10-05
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Registration:
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Live live online training only for one participant Price: $245.00 Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
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E-mail:
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webinars@GlobalCompliancePanel.com
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