Mr. Kalpeshkumar R. Vaghela is the CEO of Infra Control Systems and the Founder partner of KVS Technologies. He has 34 years’ experience as an Automation and Software Validation Specialist, Expert Trainer cum Consultant on CSV- Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9 Risk assessment- Proactive CSV Approach-Annex11- GDPR- 483 & Warning Letter Response and Remediation. For the 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 clients for many USFDA, MHRA, ANVISA, MCC, TGA Audits as a CSV- GxP consultant. He also helps the life science industry in GAP Assessment, Data Integrity Audit, and Remediation program.
About 14 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 the Governance Risk and Compliance Seminar for Information Technologies Giants like Wipro, HCL Technologies, MphasiS (Project work), etc.
He has worked with 60% of Most big pharma Companies as a CSV Consultant and Trainer. He has close to a decade of international experience working with companies located in the USA, Canada, Europe, South America, Norway, Africa, China, Japan, the Far East, and the Middle East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.
Since his two Company Infra Control Systems (CEO) & KVS Technologies (Founder Partner) is involved in real life CSV Validation, GAP Assessment, Data Integrity Audits, and remediation there is a chance for all to learn the practical way of doing the work with all problem-solving technics which can help you avoid or reduced 483 – Warning letter and Data Integrity Issues.
He is conducting training and consulting in many parts of the world which include the USA, Europe, China, the Middle East (Oman- Saudi Arabia and Iran), the Far East, Srilanka, Bangladesh.
He has conducted training at Companies like Sun Pharma, Cipla, Glenmark, Fresenius Kabi, Alembic, Biocon Group companies, Emerson Process Management, Horiba Scientific, Muscat Pharmacy, Cigalah, Tabuk and also participated in much international Data Integrity Conference as a lead speaker. many more.
IFSC CODE : KKBK0000203
MICR No.: 110485046
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