Computer System Validation

23-24 January 2019. MUMBAI, INDIA.

Overview

This training course on computer systems validation covers on how to use a risk based approach in Computer Systems Validation (CSV). The course provides compliance with GMP requirements and specifically designed for professionals. By using a risk-based approach and in-depth understanding of various CSV methodologies including GAMP5 guidelines, Validations, Annex 11 and the CFR Part 11.

Two day program in Mumbai, India

What you will learn

After completing this course, participants will:

  • Have a thorough understanding of the Validation and its application to computer systems
  • Be able use the GAMP5 Risk Based approach
  • Understand the major life cycle phases of computerized system
  • Understand Good Documentation Practices
  • Understand software categorization and the Validation efforts required for various computerised systems
  • Understand computerised system validation from a regulator’s perspective
  • Understand CFR Part 11 compliance and Annexure 11 for CSV

Key Topics

GAMP5 Guidelines – Risk based Approach
Validation
21 CFR Part 11 and Annexure 11 for CSV
IT Application
Data Integrity
Risk Assessment Based Approach

Workshop Trainer

Mr. Kalpeshkumar R. Vaghela

Mr. Kalpeshkumar R. Vaghela, CEO of Infra Control Systems has 32 years 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, TGA Customer Audits as a CSV consultant.

About 12 years of work experience on high level CSV Validation in India and abroad has made Mr. Vaghela an 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 Information Technology Companies Etc. He has worked with most big Pharma Companies as a CSV Consultant. 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.

Mr. Kalpeshkumar R. Vaghela

CEO Infra Control Systems

Mr. Kalpeshkumar R. Vaghela, CEO of Infra Control Systems has 30 years 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, TGA Customer Audits as a CSV consultant.

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