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01:30 hours
USD 249
complianceonline
Barry A. Friedman Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.
Why Should You Attend:
The objective of this interactive webinar is to explore the new Guidance for Industry on Pyrogen and Endotoxins Testing which addresses those issues that may be subject to misinterpretation, and are not covered in compendial procedures or in the currently available Guidance documents and how they impact testing within the typical Quality Control laboratory. It will also discuss the results of Low Endotoxin Recovery (LER).
Quality professionals Regulatory professionals Compliance professionals Manufacturing engineers Quality engineers Quality auditors Quality control personnel Microbiology specialists R & D personnel