North Texas Chapter: Knock, Knock, FDA is Here; Be Prepared for a Regulatory Inspection
- Eric S. Pittman, Program Division Director, Bioresearch Monitoring, West, Office of Regulatory Affairs/FDA
- Iris MacInnes, Consumer Safety Officer, Bioresearch Monitoring, West, Office of Regulatory Affairs/FDA
- 8:30-9:00 am Log on and ensure connectivity
- 9:00-11:00 am - Presentation, Questions and Answers
Program Description: This program is intended to help participants know how to be prepared for a regulatory inspection and learn about voluntary responses to an FDA-483 and what to include.
- Know how to be prepared for a regulatory inspection:
- Learn about Program Alignment and changes from a geographical-based inspectional force to a programmatic-based inspectional force.
- Know FDA reference material such as Compliance Programs and the FDA Investigations Operations Manual
- Know where to find FDA statistics such as common observations and inspectional breakdown.
- Learn about voluntary responses to an FDA-483 and what to include
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Contact hours: 2 contact hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Not applicable
Level: Basic to Intermediate