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Computer System Validation

Speaker: Nitesh Shrivastava

MakroCare Consulting organizing an Interactive Webinar on “Best practices – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5)”


In ever changing business set-up, it is a challenge to develop an appropriate Validation Program that meets business, technology and compliance needs of the industry.

It takes a lot more than just a single technology to make computer systems comply with GxP/21 CFR Part 11 requirements. It involves, good quality processes and controls to have the systems comply with regulations and hold them in a validated state.

MakroCare Consulting is presenting a webinar that focus on some of the challenges faced by industry in conceptualizing and implementing a validation program. This webinar explores with the audience the challenges in general and provides an advanced approach to Computer System Validation and compliance to 21 CFR Part 11.

Industry Speakers:
Nitesh Shrivastava (USA):
BE, MS, ASQ CQA, has over 10 years of experience in providing Regulatory and CSV consulting to US FDA regulated Industries. He has been providing compliance solutions for Computer Systems used in Manufacturing, Laboratories, and IT. He has held senior consultant positions in Validation, Quality and IT Compliance. He routinely performs Compliance and Risk Assessments, and GMP/Part11 Audits.
Udaya Kumar Chandrashekar (USA):
MS, PMP, ASQ CQA is a practicing consultant with over 16 years of experience in Healthcare, IT and Distribution domains. He has held positions including that of Sr Manager and Vice President and has provided consulting services from medium sized to Fortune 500 companies. He specializes in providing validation strategy, development of validation program and, multi-site/multi-shore IT project management

Tinoy Abraham (USA):
BS, MBA, has over 8 years of experience in the FDA-regulated industries of pharmaceuticals, medical devices, clinical trials, and drug development specializing in Computer System Validation. He has been providing the expert guidance and consulting services to top executives of various companies across the industries.

Key Topics:

  • Overview on CSV and 21 CFR Part 11
  • Risk Management and GAMP5 Risk Based approach
  • Keeping the computer system in validated state – Change Management
  • General challenges in building an effective validation program
  • Selling a Validation Program to higher Management – Business returns
  • Managing Validation Projects
The First Step

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