21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Reduce the Occurrence of 483s
Duration: 90 Minutes
This webinar will discuss developing procedures for meeting Part 11 and Annex 11 requirements; Standard Operating Procedure for systems development and maintenance; Standard Operating Procedures for step-by-step activities; measure quality and demonstrate compliance to 21 Part 11 and Annex 11; and produce quality records.
During the last several years, the FDA has increased its emphasis on Quality. At the same time New Technologies are changing the way many things are done in the Pharmaceutical, Medical Device industries. This has increased the importance and use of 21 CFR Part 11 and Annex 11. It is vital that the industries keep their procedures and practices up to date.
Why Should you Attend
- The role of the various documentation
- The role of SOPs in the preparation and management of that documentation
- The organization of processes and sub-processes that require SOPs
- How to prepare necessary systems development SOPs
- The content and format of those SOPs
- The responsibilities of the various stakeholders
This course will put you in a position to better comply to 21 Part 11 and Annex 11 Requirements. It will also make it possible to demonstrate compliance.
Objectives of the Presentation
Who can Benefit
- How to organize the development and support of computer systems
- How to develop SOPs that can help this task
- The development of training modules to support the SOPs
- The production of "products" that document systems requirements, design, testing, and others
- How to apply change control
- Who are and what are the roles of the various stakeholders?
- Quality Assurance Staff
- Subject Managers
- IT Staff
- Regulatory Affairs