Mr. Kalpeshkumar R. Vaghela is the CEO of Infra Control Systems and Founder partner of KVS Technologies.
He has 34 years’ experience as Automation and Software Validation Specialist, Expert Trainer on CSV- Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9 Risk assessment- Proactive CSV Approach-Annex11- GDPR- Remediation.
Since last two decades Mr. Kalpeshkumar Vaghela has been helping Indian and International Pharma – Process Companies achieve compliance by training and motivating professionals for QbD, and Right First Time Approach.
He has supported client for many USFDA, MHRA, ANVISA, MCC, TGA Audits as a CSV- GxP consultant.
He also helps in GAP Assessment, Data Integrity Audit and Remediation program.