21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

MessageThis Webinar is over
Date Oct 18, 2018
Time (9 AM – 5 PM)
Cost 87230.00
Online
The Seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Why You Should Attend:
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Areas Covered in the Session :
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy
  • System Risk Assessment
  • GAMP 5 “V” Model
  • 21 CFR Part 11
  • Electronic Records/Electronic Signatures (ER/ES)
  • Security, Access, Change Control and Audit Trail
  • Policies and Procedures
  • Training and Organizational Change Management
  • Industry Best Practices and Common Pitfalls

 


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