North Texas Chapter: Knock, Knock, FDA is Here; Be Prepared for a Regulatory Inspection

When:  Nov 7, 2020 from 8:30 AM to 11:00 AM (CT)
Associated with  ACRP North Texas Chapter

North Texas Chapter: Knock, Knock, FDA is Here; Be Prepared for a Regulatory Inspection


PLEASE CLICK HERE TO PURCHASE CONTACT HOURS.


Speaker:
  • 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
Program Agenda:
  • 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.


Learning Objectives:                                                                                  
  • 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
Target Audience:
  • CRCs
  • CRAs
  • Investigators
  • Auditors
  • 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

Registration Cost: 

  • $0 for all attendees

Refund Policy: Not applicable

Level: Basic to Intermediate

Location

Dial-in Instructions:
Instructions to be provided to all registered attendees prior to the event.