FDA Inspection: From SOP to 483
Duration: 60 Minutes
This FDA Inspection process training 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.
Objectives of the Presentation
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you are in charge of compliance, usually in the background and now you are 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 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.
Who will Benefit
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
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Download Agenda- How to prepare for an FDA inspection
- Development and contents of an SOP for FDA inspection
- Personnel training before inspection
- How to behave during an inspection
- Limitations of the scope of an inspection
- Response to investigation findings
- FDA guidance documents used by their inspectors
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you are in charge of compliance, usually in the background and now you are 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 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.
Who will Benefit
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Executive/senior management
- Regulatory management
- QA management
- Any person who may have direct interaction with FDA officials
- Consultants
- Quality system auditors
- Quality Engineers
- Compliance Specialists
- Compliance Leaders
- CAPA Specialists
- Management Representatives
- Compliance Managers and Directors
- Quality Managers and Directors
- Consultants and Contractors
How it works
Live Session - How it works
- Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
- The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
- Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
- Login to the audio conference on the scheduled date and time
- Get answers to your queries through interactive Q&A sessions via chat at the end of the session
- Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
- Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
- Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
- Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
- Please click on the link to access the Recorded Session
- Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
- Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
- Please share your valuable Feedback at the end of the session
Instructor Profile:
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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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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