Inspection Perspective — Tales from a Recent FDA Inspection

THURSDAY, SEPTEMBER 10th | FREE WEBINAR
30 MINUTES + Q&A | 5pm CEST | 4pm BST | 11am EDT | 8am PDT

ABSTRACT

The expectations of regulatory inspectors are rising over time - requirements are getting tighter and sponsors are expected to make better use of their systems and data. Our speaker has very relevant experience from hosting an FDA inspection (2019) where this reality was clearly illustrated.

LEARN ABOUT:

  • How this sponsor overcame a rough monitoring and documentation situation.
  • What inspectors are seeking about Oversight evidence
  • Their thoughts on the processes and systems used for the Trial Master File and the Investigator Study File (ISF)
  • Practical steps you can take to protect your study / clinical asset even if things go awry
  • Why myClin played a crucial role in "documenting the story of the study" and aiding successful navigation of that inspection.

Lorne Cheeseman

Senior Director Quality, Various Biopharma
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Inspection Perspective — Tales from a Recent FDA Inspection

10/9/20208:00am PDT30 minutes
ABSTRACT:
The expectations of regulatory inspectors are rising over time - requirements are getting tighter and sponsors are expected to make better use of their systems and data. Our speaker has very relevant experience from hosting an FDA inspection (2019) where this reality was clearly illustrated.

Learn about:
* How this sponsor overcame a rough monitoring and documentation situation.
* What inspectors are seeking about Oversight evidence
* Their thoughts on the processes and systems used for the Trial Master File and the Investigator Study File (ISF)
* Practical steps you can take to protect your study / clinical asset even if things go awry
* Why myClin played a crucial role in "documenting the story of the study" and aiding successful navigation of that inspection.