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FDA’S Perspective on Auditing Investigator Sponsored Studies



 
Our Price: $395.00

Product Code: WB-7071
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About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.


In order to evaluate the trial conduct and compliance with quality systems, SOPs, protocols, good clinical practices, and other applicable regulatory requirements, the FDA reserves the ability to audit or examine an investigator study at any time. Anxious anticipation has begun to spread throughout the industry due to the many recent modifications to the applicable regulatory and compliance guidelines. When, how, and why these audits will take place are necessary considerations in ensuring proper preparation for what may be an increase in future FDA auditing in investigator initiated research.
  • Outlining the various types of audits and their applicability
  • Current FDA inspection trends and findings
  • Proactive measures for industry to ensure studies and sites are audit ready
  • Post-inspection processes and follow-up

Speaker:

Irfan Khan
Operations and Outreach Lead Consumer Safety Officer
DBM | OC | CDRH | FDA


Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Investigator Initiated Research
  • Medical Affairs
  • Clinical Affairs & Operations
  • Auditors
  • Quality Assurance
  • Regulatory Affairs

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