21 CFR Part 11 Fundamentals
The FDA has communicated the intention to step up enforcement on many regulations including those for electronic records and signatures. Even if you missed the first wave of Part 11 fever in the late 1990's, it's not too late to catch up now!
In this free webinar, you will learn why 21 CFR Part 11 was legislated in the first place, and how the FDA's enforcement has changed over time.
You will come to understand the detailed requirements within Part 11 for electronic records, electronic signatures, and open systems.
We will also provide a step-by-step approach for how to launch and execute your own Part 11 compliance initiative.
And finally, we will review recent FDA Warning Letters for electronic record issues, so you can prevent your company from making the same mistakes.
Part 11 Webinar Topics
- The history of 21 CFR Part 11: When and why was this regulation enacted?
- What records and signatures does Part 11 apply to? And, what records and signatures are outside the scope of the regulations?
- Part 11 technical, procedural, and documentation requirements for electronic records, electronic signatures, and open systems
- FDA Guidance on compliance with Part 11
- Step by step methodology for executing your Part 11 compliance project
- Metrics and trends in the FDA's enforcement of 21 CFR Part 11
- Examples of recent FDA Warning Letters for electronic records violations
- Thoughts on the future of Part 11