Regulated Bioanalysis Workshop:
Requirements and Expectations
June 30, 2020
This training is focused on presenting an overview of how FDA’s Center for Drug Evaluation and Research approaches different issues in bioanalysis. The audience will gain and deeper and broader understanding of how bioanalysis must be performed to adequately support regulated activities and how FDA performs bioanalysis to further the agency’s mission and support regulated industry. Attendees will have the opportunity to learn firsthand how the offices that review and conduct bioanalysis conduct their work in this field.
Continuing Education Credit
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion
- is eligible for SOCRA credit 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. Candidate must provide documentation of participation.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
- Continuing education certificates are available only for those who attend real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.
The agenda may change over time. New versions will be linked here. The current version is version 7, updated on June 29, 2020.
ZIP of Session Slides
The Session Recordings are available on the
CDER SBIA YouTube Page
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