Years of Experience: 30+ years
Areas of Expertise: CSV and Data Integrity Audit
Mr. Kalpeshkumar R. Vaghela is the CEO of Infra Control Systems. He has 30 years of experience as Software Validation Specialist, Expert Trainer CSV- Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9, Risk assessment- Proactive CSV Approach . Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve compliance by training and motivating professionals for QbD and Right First Time Approach. He has supported client for many USFDA, MHA, ANVISA, MCC, and TGA Customer Audits as a CSV consultant.
About 11 years of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela a subject matter expert in CSV, Data Integrity Audit for Life Science- Medical Device and Clinical Research Industry. He is also conducting Governance-Risk and Compliance Seminar for IT giants like Wipro, HCL technologies Etc.
He has worked with 80% of most big pharma companies as a CSV Consultant and Trainer. He has close to a decade of international experience of working with companies located in USA, Canada, Europe, South America, Norway, Africa, Middle East, China, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.