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What You Need to Know: FDA Auditing in Medical Device Investigator Sponsored Studies
What You Need to Know: FDA Auditing in Medical Device Investigator Sponsored Studies


 
Our Price: $395.00

Product Code: WB-7069
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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 guide¬lines. 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.
  • Ensuring studies and sites are audit ready
  • Circumstances that can lead to inspections
  • Post-inspection strategies: moving forward

Speaker:
Celeste M. Gonzalez
Senior Clinical Quality Assurance Consultant


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


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