This course is available for onsite or custom training. Please contact us if you are interested in scheduling this class for your group.
The FDA has recently 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 session, you will learn why 21 CFR Part 11 was legislated in the first place, and how the FDA’s enforcement has changed over time. Then you’ll come to understand the detailed requirements within Part 11 for electronic records, electronic signatures, and open systems. For each requirement, you’ll receive practical advice on how to achieve compliance. For example, did you know that system modifications are not necessarily the best approach for complying with many sections of Part 11? You will also review the step-by-step details for how to launch and execute your own Part 11 compliance initiative. And finally, you will review recent FDA Warning Letters for electronic record issues, so you can prevent your company from making the same mistakes.
- Step by step methodology for executing your Part 11 compliance project
- Practical approaches for compliance with Part 11 requirements
- Which records and signatures Part 11 applies to? And, which 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
- The history of 21 CFR Part 11: When and why was this regulation enacted?
- Metrics and trends in the FDA’s enforcement of 21 CFR Part 11
- Examples of recent FDA Warning Letters for electronic records violations