The most common CMC deficiency indentified by FDA reviewers is inadequate process validation. A manufacturer needs to establish objective evidence that a process consistently produces a result or product, meeting its predetermined specifications. Validation of all processes involved in manufacture of drug and biologics is essential for meeting FDA’s Good Manufacturing Practices (GMP) requirements. Process validation is considered as the first step in process development for manufacturing biopharmaceuticals. This 90-minute session with our expert speaker Dr. Mukesh Kumar will highlight the latest guidance from FDA regarding process validation. He would summarize the FDA-acceptable 3-step method that can be used for process validation of most manufacturing and testing methods. Attendees will be able to evaluate process validation reports.
This program will discuss key strategic considerations using real-life case studies. At the end of the webinar, attendees will be able to evaluate validation requirements for any given process, the documentation requirements, and the audit issues with regards to FDA acceptability of the same.
FDA’s first guidance on process validation was released almost 25 years ago. Since then, manufacturing technology has come a long way and so has the diversity in the products, technologies and processes used in manufacture of drugs and biologics. Realizing this, FDA released a new guidance in 2011 to address modern process validation methods. This guidance works in conjunction with several other guidance documents, addressed quality system and quality management practices. This session will provide a brief introduction to the history and a detailed analysis of the currently acceptable practices, using case studies and examples.
Highlights of the session are:
Who should attend? Regulatory affairs professionals, personnel in development, manufacturing, QC testing, project managers, CMC writers, technical writers, Regulatory Compliance Associates, managers and people investing in FDA-regulated product development projects.
- Dr. David Lim
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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