Webinar ID:   ICT115

CSV and Data Integrity Virtual Boot Camp

  8.5 Hours (4 Days)

Categories:   Uncategorised,
** Note: You can sign up for entire boot camp at discounted rate (Recommended) or individual sessions (see below)

Session 1:

17 June 2020 | 6 – 8 PM

  • 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 vs Validation
Register for Session 1 only

Session 2:

18 June 2020 | 6 – 8.30 PM

  • 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
  • Benefits of risk in larger project
Register for Session 2 only

Session 3:

19 June 2020 | 6 – 8 PM

  • 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 – How FDA & other Regulatory Authorities Inspect
  • Computerized Systems for Data Integrity
  • Handling Data Integrity issues during a Pandemic
Register for Session 3 only

Session 4:

20 June 2020 | 5.30 – 7.30 PM

  • 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
  • Understand what does and does not need to be validated
  • Avoid 483s and Warning Letters
  • Reduce validation time and costs
Register for Session 4 only


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.

This latest series on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.

There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 60% inspection reports such as 483’s and Warning Letters quote data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Mr. Kalpesh Vaghela’s extensive years of experience in Data Integrity can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters.

Why You Should Attend:

This virtual workshop provides the regulatory background and guides attendees through the complete record lifecycle from data evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA’s Part 11 and the Annex 11.

Our instructor will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learning from this course, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation. The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations.

A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Oral Solid Dosage Form, Contract Laboratories, Clinical research Organizations, Contract Research Organisations, Contract Manufacturing Organisations and Biopharma companies.


  • Quality Control & Quality Assurance
  • Research and Development
  • Laboratory
  • Regulatory Compliance
  • IT/IS & Software Departments
  • Validation
  • Production & Manufacturing
  • Documentation
  • Training Departments

  • Managers and Supervisors
  • Senior Managers and Team Leaders
  • Directors, VP’s, CxO’s, General Managers
  • Analytical Chemists
  • Validation Specialists
  • Laboratory Managers and Supervisors
  • Regulatory Affairs Managers
  • Documentation Specialists & Analysts
  • Consultants and Systems Administrators