Alan Hoffmeister is the Senior Product Specialist for the Microbial Solutions division of Charles River Laboratories. His experience with the bacterial endotoxins test dates back to 1988, during which time he has been involved in all aspects of the assay, including the design and development of BET-specific instrumentation and software.
He has directed workshops and training courses and lectured internationally on a variety of BET-related topics, including LAL methodologies, system qualification, product validations, 21 CFR Part 11, process analytical technologies (PAT) and BET regulatory affairs. He has also contributed to the development of many BET protocols, technical sheets and monographs for domestic and international organizations.
- Webinar: Bacterial Endotoxin Testing in the Medical Device Industry
- Blog: Eureka: Recombinant Factor C Under the Microscope
- Journal: American Pharmaceutical Review: QC Micro
- Video: ISPE: A Strategic Approach to Data Integrity Compliance
- Webinar: BioPharma Asia Validation of Microbiological Methods – Expectations for Regulatory Compliance
- Journal: European Pharmaceutical Review: Product Hub: Charles River’s Endosafe® Nexus™