Office of Study Integrity and Surveillance Workshop 2022:
CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
July 19-20, 2022
This workshop will:
- Describe the Mission and Vision of the Office of Study Integrity and Surveillance (OSIS)
- Identify the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection
- Provide an overview of compliance programs dealing with inspections of facilities that perform Good Laboratory Practice (GLP), Animal Rule (AR), In Vivo Clinical Bioavailability (BA) -Bioequivalence (BE) , In Vivo Analytical BA/BE
- Engage attendees to work through case studies representative of the above programs.
The agenda may be updated and new versions linked here. The current version is v2, updated on June 21, 2022.
The speaker biographies document contins detailed information on the Workshop speakers.
The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room.
The links below to the Adobe Connect rooms will be activated shortly before the event begins.
Please select the correct room based on the first letter of your LAST NAME.
Select the first room if you require closed captioning.
Download Presentation Slides:
The links above will become active on the day before the workshop.
Evaluation & Certificate:
Evaluation & Certificate of Attendance
The above link will become active near the close of the second day of the Workshop.
The recordings of the Forum sessions will be linked here as soon as they are available.
- pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
- pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This workshop has been:
If you have questions regarding the content of the event or other CDER-specific information, please: