21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

Date	Oct 18, 2018
Time	11:00 PM EDT
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