ComplianceOnline, Online Event
2012-06-21
Description
This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance. This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation. Areas Covered in the Seminar: - How to prepare for an FDA inspection?
- Development and contents of an SOP for FDA inspection.
- Reliance of FDA inspectors on compliance program guide manuals.
- Reliance of FDA inspectors on other external sources.
- Personnel training before inspection.
- In depth review and summary of QSIT.
- Use of QSIT for internal auditing.
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Invited Speakers:
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Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
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