This 21 CFR part11 virtual conference will discuss the scope and how to pass a part 11 inspection and how to best use and implement audit trails for part 11 compliance.
Why Should You Attend:
FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. The number of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready - we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best use and implement Audit Trails and certainly we have challenges with internal and external auditing for Part 11 compliance.
This webinar will address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails - especially since Audit Trails play major role in Part 11 compliance - they can be your best friends and/or worst enemies at the same time.
How It Works:
This 21 Cfr Part 11 webinar has 4 modules, 2 modules 55 minutes each and 2 modules 25 minutes each. Our speaker will deliver the modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants can ask questions and clarify information. The modules also include multiple-choice questions to help participants assure they understand the material. Some of the modules contain exercises for participants that help illustrate the points covered and further increase learning. The interactive portion includes a discussion of the questions and exercises.
- 2:00 PM EST - 2:55 PM EST - Module 1 (includes 5-10 min Q&A)
- 2:55 PM EST - 3:00 PM EST - Break
- 3:00 PM EST - 3:55 PM EST - Module 2 (includes 5-10 min Q&A)
- 3:55 PM EST - 4:00 PM EST - Break
- 4:00 PM EST - 4:55 PM EST - Module 3 (includes 5-10 min Q&A)
- 4:55 PM EST - 5:00 PM EST - Break
- 5:00 PM EST - 5:25 PM EST - Module 4 (includes 5 min Q&A)
- 5:25 PM EST - 5:30 PM EST - Break
- 5:30 PM EST - 5:55 PM EST - Module 4 (includes 5-10 min Q&A)
- 5:55 PM EST - 6:00 PM EST - Final Q&A
Who Will Benefit:
- Quality Managers
- Quality Engineers
- Small business owners
- CAPA investigators
- Six Sigma specialists
For More Information: