This course gives you insight into CEP procedures sequentially from submission to approval in a simpler way. It covers introduction, approval process & certification, inspection program, suspension withdrawal & closure. It also discusses how to address changes in CEP. This knowledge will give you the confidence to face interviews successfully.
B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.
- Section 1: CEP submission
- EDQM, CEP, Application form, QOS, Evaluation, approval, certification database, validity, inspections 151 minutes
- CEP: Suspension, withdrawal, closure, revision & renewal 95 minutes