How to Prepare for an FDA Audit
Speaker: Astrid Eder, Ph.D., CIP, CCRP
Program Agenda:
- 5:15 – 5:30 pm – Registration
- 5:30 – 6:30 pm – Presentation
- 6:30 – 7 pm – Networking
Registration Cost: There is no cost for attending the meeting. Non-members are welcome to attend the meeting.
Program Description:The presentation will provide an introduction to the FDA Bioresearch Monitoring Program and describe when an FDA inspection is likely to be scheduled. The talk will include the steps of an FDA inspection, expand on what the FDA inspector is evaluating based on the investigator’s responsibilities per 21 CFR 312.60 and Form FDA 1572, describe the forms and letters related to an FDA inspection, and list and expand on common findings of an FDA inspection. Attendees will be offered an approach to write effective Corrective and Preventative Action (CAPA) plans.
Upon completion of this Presentation, attendees will gain an understanding of:
- 1. FDA oversight of drug and device development
- 2. How FDA inspections are conducted
- 3. How to prepare for an FDA Inspection
- 4. How to respond to a Form 483 or Establishment Inspection Report (EIR)
- 5. How to write an effective Corrective and Preventative Action (CAPA) plan
Contact hours: 1 Contact hour has 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 registration desk, and attend the program. Log on to the ACRP website, then “ACRP Learning Portal” 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: No refunds will be provided unless the chapter cancels program.
Level: Core level.
Target Audience: All Clinical Research Professionals.We invite your active participation in our local chapter. Your participation will help our chapter develop into a group that meets the needs of our members. It will also enable us to continue to offer excellent educational programming. If you are interested in presenting or have a suggestion for a program or speaker OR if you are interested in participating on one of our Chapter’s committees OR have information or ideas for the Front Range Newsletter, please contact any Board member. We want to know how we can best meet your interests and needs and also utilize the skills, ideas, and energies of each of our members.