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The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics. These methods include analytical procedures that test for identity, purity, potency, and stability of drug substances and drug products. Selecting the right method to validate or if a method is ready for validation starts with the research lab or method development lab. Understanding the requirements for a method to be considered validated helps with the selection process. Also, having a thorough understanding of regulatory agency expectations can prevent unnecessary problems with the acceptance of analytical methods . This 3 hour webinar will describe essential practices for bringing analytical methods from development through validation.
Topics covered include:
This webinar will provide valuable assistance to all personnel in:
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.