Through its Part 11 inspection and enforcement program, the FDA has continued with its enforcement action. 30 warning letters were issued by the FDA related to Part 11 violations in the last three years alone. Most of the citations were related to security, integrity and availability of electronic records while some were related to software and computer systems validation.
However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what FDA assesses in these inspections.
To get a better insight, join expert speaker Angela Bazigos in this live webinar as she helps you get a better understanding of what 21 CFR 11 means and why and how it was implemented. She will also discuss FDA’s view of what is enforced under Part 11 inspections, and how you can prepare your company for the upcoming Part 11 inspection.
Who should attend?
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & Software Validation.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups...
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