Kalpesh Kumar Vaghela

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.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

  • Areas Covered in the Session : 21 CFR Part 11 compliance of a computer system Electronic Records & Electronic Signatures How to develop GxP compliant spreadsheet applications Learn how to use Excel’s built in 21 CFR Part 11 features...
  • Areas Covered in the Session : Understanding Data Integrity and Security Most frequent data integrity issues & their impact Knowing the occurrence of data integrity failures Data Backup, Restoration, Archival & Retrieval, Retention ALCOA+ Maintenance Qualification Data integrity Inspections...
  • Areas Covered in the Session : CSV Components and Deliverables URS, FS & DS TRM, SR, IRA and FRA Risk Based Approach for CSV Understanding Risk Assessment Risk-Based Validation approach to lower costs Regulatory Expectations Examples and Good Practices...
  • Areas Covered in the Session : Formation of Validation Team Writing Effective URS Deliverable SRS and GxP Assessment (Template discuss GxP Assessment) Qualification (IQ, OQ, PQ) and Traceability Matrix Effective Installation and Testing Effective SOPs Validation & Revalidation Qualification...