This seminar will help you get familiar with the FDA – compliant implementation of 21 CFR Part 11 requirements applicable to the regulated industry.
Mr. Kalpesh R. Vaghela, is the CEO of Infra ControlSystems. He has 30 years experience as SoftwareValidation Specialist, Expert Trainer CSV, cGMP, DataIntegrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9,Risk Assessment. He has also worked in Elecronics andInstrumentation Engineering fields. Since last twodecades Mr. Vaghela has been helping Indian andInternational Pharma Companies achieve Compliance by training and motivating professionals for Right FirstTime Approach. He has supported many USFDA, MHA,ANVISA, MCC, TGA Customer Audits, as a consultant.