Training Dates: 14 APR 2021 to 16 APR 2021
Batch Timings: 06:00 PM to 09:00 PM IST
Programme Duration: 09 Hours (Daily 3 hours)
Rs 9,000 + (GST 18% extra) = Rs 10,620/- (Including GST)
Note: Please scroll down to know about the trainer, Key Topics and Programme deliverables
25+ years of FDA/EU-related expertise with Good Manufacturing Practice (GMP) regulations, Quality System Regulation (QSR) and Part 11;EU GMP Annex 11 regulations
A combination of work experience as a former FDA Investigator; management positions within pharmaceutical companies in a regulatory compliance role; and as a director/consultant in a business unit of a very large organisation, specializing in GMP regulatory compliance matters.
Extensive experience with preparing companies for FDA Pre-Approval inspections.
Hands-on experience with designing & building Quality Systems.
Experience working a software quality assurance (SQA) role
Authored and co-authored several technical articles.
Frequent industry speaker on a wide variety of topics.
Expert GMP and Quality Systems Consultant skilled to provide timely solutions to clients in the pharmaceutical, biotechnology and medical device industries.
Worked as a Investigator who has also worked in the pharmaceutical and biotech industries as a regulatory compliance professional
***Followed by quiz and question answer session***