21 CFR Part 11 refers to regulations allowing FDA to accept electronic records and signatures in place of paper records and handwritten signatures. This training program is aimed at providing foundation to 21 CFR Part 11 regulations along with soft skills development in a workshop setting.
- A one-day workshop based training program aimed at providing foundation to 21 CFR Part 11 regulations
- Focus Area:
- 21 CFR Part 11 Electronic Records; Electronic Signatures
- Electronic Data Capture in Clinical Trials (EDC)- The Auditor's View
- Case Studies
- Group discussions, Team Exercise
- On successful completion a certificate is awarded by Catalyst Clinical Services Pvt. Ltd.