Customer Testimonials
|
|
Subscribe NewsletterAre you on the correct path to ensure compliance of your Information Systems with 21 CFR Part 11?
Product Id
:
600038
Overview: This Webinar would benefit company personnel that are responsible for the procedural and/or software requirements to ensure compliance with Part 11 of Title 21 of the Code of Federal Regulation.
Do you have a firm understanding of the scope and criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records?
Do you have a firm understanding of the scope and criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records?
Part 11 of Title 21 of the Code of Federal Regulation was passed by the FDA in 1997 and established standards for the use of electronic records and signatures. Many companies in the pharmaceutical, medical device, biotechnology and services industries are finding themselves challenged to ensure regulatory compliance through all their operations due to their lack of understanding the full impact of 21 CFR Part 11 on Information Systems. Once a clear picture of the scope of the CFR is understood, companies will find compliance as not just another regulatory exercise but an opportunity to incorporate technology into the current business processes.
Areas Covered in the Session:
- Why 21 CFR Part 11
- Scope of 21 CFR Part 11
- Software requirements of 21 CFR Part 11
- Importance of system validation
- Roadmap for compliance with 21CFR Part 11
- Framework for system validation
Who Will Benefit: The employee who will benefit include:
- Information Technology personnel who support systems that govern any cGXP process
- Quality Assurance personnel
- Quality system auditors