Validation of Microbiological Methods – Expectations for Regulatory Compliance
22nd May 2015 | 9PM ET (05/21/2015) / 2AM BST / 3AM CEST | Dr. Rajesh K. Gupta Scientific & Compliance Consultant and Alan Hoffmeister, Global Field Technical Manager for Charles River |WATCH FOR FREE
Rajesh K. Gupta has a Ph.D. in microbiology and is Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years’ experience in the development, production, testing and regulation of biologics, working at both the regulatory agencies and the industry. At FDA, CBER, he was a Deputy Director and Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods. In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH), in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and made numerous presentations at scientific and regulatory meetings.
Sponsored by Charles River Laboratories
Charles River is a global provider of comprehensive and innovative microbial QC products and testing solutions. Our portfolio of rapid Endosafe® endotoxin testing systems and FDA-licensed LAL cartridge technology improves operational efficiencies by enhancing ease of use and accelerating testing times. The handheld Endosafe®-PTS™ system simplifies endotoxin testing to deliver real-time, point-of-sample results in 15 minutes. All necessary LAL reagents are condensed into a single disposable cartridge for easy, one-button operation. We can also support your environmental monitoring program with cost-effective microbial identification and strain typing with our Accugenix® services. All microbial identifications are conducted in an FDA-registered lab using Accugenix® DNA sequence and MALDI-TOF reference libraries, which profile more relevant microorganisms than any other service laboratory or database in the industry. Whether faced with critical timelines or stringent regulations, you can rely on Charles River to ensure the safe manufacture and timely release of your product.
Alan Hoffmeister is the Global Field Technical Manager for Charles River, Endotoxin and Microbial Detection (EMD). Alan’s experience with the Bacterial Endotoxins Test (BET) dates back to 1988, since then he has been involved in all aspects of the assay. Alan has directed workshops and training courses and lectured internationally on a variety of BET topics including LAL Methodologies, Product Validations, and BET Regulatory Affairs. He has also contributed to the development of BET protocols, technical guides and fact sheets for domestic and international organisations.