Do's and Don'ts during FDA Inspections
03:00 PM ET | 12:00 PM PT | 04:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"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"
How to change and improve your ways of preparing for and getting ready for an FDA inspection
This webinar will provide useful and practical information for you to consider and implement for your organization, significantly contributing to hosting successful FDA inspections. At the end of the webinar, you will learn what and how to change and improve your ways of preparing for and getting ready for an FDA inspection.
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.
• 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
Who will Benefit
• Internal / External Auditors
• Regulatory Management
• Quality Assurance Professionals
• Sales/Marketing Management
• Senior and mid-level Management
• Regulatory Affairs
• Operations and Manufacturing
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.