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
