|
An Overview of the Electronic Records and Signature Rule - 21 CFR Part 11
|
Course
0727
-
1
Day
-
.7
CEU
Call for pricing at your location.
Key Session Topics
- Determine when Part 11 does or does not apply to electronic data and documents
- Identify and comply with Part 11 requirements
- Identify and comply with predicate rule requirements related to computerized systems and electronic records
- Apply risk analysis techniques to assess Part 11 applicability for individual computer and software systems
- Develop understanding of Part 11 controls
- Understand validation requirements for computer and software systems, including commercial off-the-shelf (COTS) systems
- Understand internal audit implications
- Anticipate FDA inspectors' expectations for Part 11
|
Why SAI Global?
- Our courses teach real-world business objectives in an
interactive learning environment.
- Our instructors have an average of 20 years industry experience.
- We offer excellent customer service.
- We have maintained a 98.9% approval rating among more than 200,000
training participants.
|
If you have questions about this course,
submit a
Course Information
Request
or call us at 1-800-374-3818.
To learn about the savings and instructional benefits of training five or more participants
at your location, submit an
On-Site Quote Request
or call us at 1-800-374-3818.
To learn how you can save 10% - 30% on course registrations with SAI Global as your preferred training provider, submit a
Customer Rewards Request or call us at 1-800-374-3818.
|
Course Agenda
In August, 1997, the FDA published the regulations for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records. This course discusses why Title 21 of Code of Federal Regulations Part 11, or "21 CFR Part 11" was developed, the evolution of the regulations, the role Part 11 plays in the adherence to other sections of 21 CFR, and explores the impact of compliance for your organization.
Who Should Attend
- Quality Managers or professionals responsible for Part 11 compliance
- Information Technology professionals responsible for computer system validation and or Part 11 compliance issues
- Internal Auditors seeking understanding of how to better audit against 21 CFR Part 11 criteria
- Anyone desiring better understanding of 21 CFR Part 11 requirements
Prerequisites
There are no specific prerequisites for this course
|