Do’s and Don’ts during FDA Inspections
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Why Should you Attend
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional – you’re in charge of compliance, usually in the background, and now you’re in the spotlight, and if your performance isn’t good, it’s not the show that may close, it’s your company! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
Objectives of the Presentation
- How to prepare for an FDA inspection
- Development and content of an SOP for FDA inspection
- Personnel training before inspection
- How to behave during an inspection
- What to show FDA during an inspection
- Proper Post-inspection Follow-up
- Limitations and scope of inspection
- Response to investigation findings
- FDA guidance documents used by their inspectors
Many firms use an ad hoc “war room” mentality for managing inspections rather than a pre-established well-planned strategy to guide the firm through an inspection. The managerial option then, is management through high anxiety or management through rational prediction. When an FDA investigator begins inspection, he/she can sense the war room anxiety approach or a defensive posture. That is not a good thing. He/She can sense the firm is fearful of what may happen next rather than sense the firm is forthright and confident about their regulatory profile. You need to discover effective tools to craft a regulatory evolution for the better. There is no reason to rely on a fingers-crossed pre-inspection strategy. You bring yourself out of a failed defensive tact. Hear from an ex-FDA investigator what the FDA looks for so you are not caught off-guard.
Who will Benefit
- Internal / External Auditors
- Regulatory Management
- Quality Assurance Professionals
- Consultants
- Sales/Marketing Management
- Senior and mid-level Management
- QA/QC
- Compliance
- Regulatory Affairs
- Operations and Manufacturing
Instructor Profile:
Jeff Kasoff
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
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Additional information
| Purchase Options | Live Access, Recorded Access, Training CD/DVD, USB Flash Drive, Live+Recorded Access, Live Access+CD/DVD, Live Access+USB Flash Drive |
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