Domestic Inspections and Risk Assessment Whats the same and whats Different with the FDAs Resumed Operations?

Michael C Redmond

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The global COVID-19 pandemic forced the FDA to halt domestic and foreign inspections, leaving drug and device manufacturers waiting for pre-approval inspections, missing user-fee approval dates and stuck in official action indicated status. Unless your inspection was deemed “mission critical,” it didn’t happen.

But that’s starting to change. The FDA stated in July that it would resume certain domestic inspections and this webinar can help you prepare.

Our Expert will share how assessments are proceeding and what criteria the organization is using to determine which sites are inspected. Through this webinar, you’ll gain insights into how to prepare for an on-site review, from extended records requests to appropriate personnel access. We’ll also consider how the FDA is deciding on remote inspections and ways to equip your team for this method of assessment.

Key Webinar Takeaways:

  • FDA Criteria for In-Person Inspections
    1. Safety and the COVID-19 Advisory Rating system

 

  • Alternatives to On-Site Inspections
    1. Records requests, including access to electronic databases, screen shots, live-video functions, or long-running documents
    2. Remote and hybrid assessments
    3. Appropriate personnel access

 

  • Preparation for FDA Inspections
    1. Gaining clarity on domestic inspections criteria
    2. Standard approaches to 704(a) requests

 

  • The Likelihood of Foreign Inspections Resuming
    1. Mutual Recognition Agreements (MRA)
    2. Pharmaceutical Inspection Co-Operation Schemes (PIC/S)

Whether your site is chosen for an on-site inspection, will go through a remote review or is awaiting assessment, you need to be prepared. Let us help ensure your team is ready for whatever interactions with the FDA come next.

Join us by registering today.

 

Who Will Benefit

  • Pharmaceutical and biotech companies
  • Medical device companies
  • Regulatory affairs professionals
  • Government affairs professionals
  • Quality unit professionals
  • Inspections and audit staff
  • Post-market safety staff
  • QSR and GMP professionals
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.


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