21 CFR Part 11 and Risk Assessment – Avoid Warning Letters and Reduce Costs

29,500.00

Product Id : INDSEM128
Presenter : Kalpesh Kumar Vaghela
Scheduled On : July 25 – 26, 2019
Duration : 2 Days
 
Price : Rs. 25000 + 18% GST for 1 Delegate

 

SKU: INDSEM128

Our instructor will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation.

Purchase Options

1. Live Session, 2. Recording Access, 3. Live & Recording Combo

Presenter Details

Kalpesh Kumar Vaghela
Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.