Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies 2012
25 Jul 2012
Webinar
Key Topics
Review current FDA inspection of quality system software, such as complaints, CAPA, etc
Review current FDA inspection of automated manufacturing systems
What are the planning issues for a remediation project?
How do I determine which systems require remediation?
Software validation concerns
Special considerations for multi-site and global systems
Remediation project planning guidelines
21 CFR part 11 (Electronic Records and Electronic Signatures) concerns
Who should Attend
Attendees from Companies that manufacture, sell, or distribute Medical Devices, Pharmaceuticals and Biologics, including:
QA Directors, Managers and personnel
Management responsible for operational and quality systems ("system owners")
Software validation and software quality managers + personnel
IT / IS managers and personnel
Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
Consultants charged with creating or evaluating part 11 programs
Quality auditors responsible for auditing and evaluating part 11 compliance
Past Events
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies 2012 - 25 Jul 2012, Webinar (30077)
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies 2026
Important
Please, check "Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Medical device, Medical laboratories, Pharma
