Reduce Costs for Compliance with Data Integrity:  21CFR Part 11, SaaS/Cloud, EU GDPR

FCSL would like to announce the following GRC 2-day seminar:

Reduce Costs for Compliance with Data Integrity:  21CFR Part 11, SaaS/Cloud, EU GDPR

David Nettleton, FDA Compliance Specialist, Computer System Validation

Philadelphia, PA, June 13-14, 2019

David Nettleton is an industry leader, author and teacher.  He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.  His popular book, Risk Based Software Validation- Ten Easy Steps, provides guidance and fill-in the blank templates for completing a COTS software validation project.   This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.


The learning objectives of this seminar include:

  • Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483s and Warning Letters
  • Learn how to buy COTS software and qualify vendors
  • Implement a computer system using risk-based validation to gain

maximum productivity and reduce cost by as much as two thirds

  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects

“Right size” change control methods that allows quick and safe system Evolution

  • Minimize the validation documentation to reduce costs without increasing

regulatory or business risk

  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe

The course is expected to benefit the following industry professionals:

  • GMP, GCP, GLP, regulatory professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors, SaaS hosting providers

For more information contact