21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

Date	Sep 13, 2018
Time	10:30 AM EDT
Cost	$87249.50
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.FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

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.

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

$100 Gift Voucher for next seminar
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

Who Should Attend :
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Laboratory Managers
• Automation Analysts
• Manufacturing and Supply Chain Managers and Analysts
• Computer System Validation Specialists
• GMP Training Specialists