Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
GAMP 5 "V" Model
System Risk Assessment
Electronic Records/Electronic Signatures (ER/ES)
CFR Part 11
Policies and Procedures
Security, Access, Change Control and Audit Trail
Industry Best Practices and Common Pitfalls
Training and Organizational Change Management
Who should Attend
Information Technology Developers and Testers
Information Technology Analysts
Clinical Data Managers and Scientists
QC/QA Managers and Analysts
Laboratory Managers
Analytical Chemists
Manufacturing and Supply Chain Managers and Analysts
Automation Analysts
GMP Training Specialists
Computer System Validation Specialists
Business System/Application Testers in FDA-Regulated Functional Areas
Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
This seminar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.
Past Events
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018 - 18-19 Oct 2018, Courtyard by Marriott Richmond Downtown, Virginia, United States (77461)
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018 - 13-14 Sep 2018, San Diego, California, United States (76687)
Important
Please, check "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" official website for possible changes, before making any traveling arrangements
