FDA Manufacturing Compliance And Inspections For Cell And Gene Therapies And Other Innovative Biologics
Lachman Vice President John McShane and Executive Director Keith Lamb recently hosted a live webinar with Arnold & Porter attorneys Howard Sklamberg and Phillip DeFedele on FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The webinar provides best practices and real-world examples for simplifying the process and addressing unique challenges during product development and commercialization of cell and gene therapy products. It is designed for pharmaceutical companies, academic institutions, and private equity and investment firms seeking to comply with current GMP requirements, FDA inspections, and manufacturing challenges.
This webinar also covers:
- Long-term benefits of making process, equipment, and facility decisions early in the development lifecycle
- The importance of having a robust QMS and framework that can be matured through the lifecycle to ensure it’s ready for licensure
- How to assess your QMS, whether your own internal quality systems or one developed by a third party
- Why you need to consider your supply chain, with tips for establishing an effective approach for each element
- Potential issues associated with Health Authority Inspections and how to avoid them
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