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
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
- Quality Assurance
- Regulatory Affairs
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
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Operations and Outreach Lead Consumer Safety Officer
DBM | OC | CDRH | FDA
Irfan Khan is the Operations and Outreach Lead for the Division of Bioresearch Monitoring within the Office of Compliance for the Center for Devices and Radiological Health. Mr. Khan received his B.A. in Computer Science and B.S. in Biology from the George Washington University, and M.S. in Biotechnology with concentration in Regulatory Affairs from the Johns Hopkins University. Mr. Khan has been with the Food and Drug Administration since 2009, and has presented to the industry at various forums. Previously, Mr. Khan worked for Westat, Contract Research Organization, as a Clinical Research Associate (CRA) on various phase I-VI drugs and devices studies.