GlobalCompliancePanel

- 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

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. Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901789SEMINAR?xprt

GlobalCompliancePanel Seminar

Day 1 Schedule

Lecture 1 (90 Mins):

'GxP' Computer Systems and FDA Oversight

Lecture 2 (90 Mins):

Computer System Validation (CSV)

Lecture 3 (90 Mins):

System Development Life Cycle Management (SDLC) Methodology

Lecture 4 (90 Mins):

FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance

Day 2 Schedule

Lecture 1 (90 Mins):

Strategic Approach to ER/ES Compliance

Lecture 2 (90 Mins):

Policies and Procedures to Support GxP Compliance with 21 CFR Part 11

Lecture 3 (90 Mins):

Training and Organizational Change Management Best Practices

Lecture 4 (90 Mins):

Industry Best Practices and Common Pitfalls