Build an in-depth knowledge of validation through to latest GAMP® 5 guidance, and specific FDA regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures from planning to reporting.

 

FDA’s expectation for Analytical MethodValidation, Verification and Transfer of Analytical Methods including Analyst Qualification, Requalification (Understanding and implementing guidelines from FDA/, USP and ICH)

Know More

With the current ongoing USFDA findings in INDIAN Drugs manufacturing facilities across INDIA
it is now very much suitable to have focus on GMP and regulatory system on the shopfloor.

Know More