Overview: Regulatory compliance requirements for CFR 21 Part 11/Annex 11 (also known as ERES) have undergone several revisions since its inception during the late 1990s. While the agencies have endeared themselves to the industry by adopting a flexible audit approach for ERES, they are increasingly requiring companies to comply with the regulations.
Increased number of citations and the recently announced "tag along" audit approach is a gentle reminder of things to come by way of stricter enforcement of Part 11/Annex 11. It is critical that the industry becomes familiar with the intricacies of the regulation so as to ensure that audits of their systems in this area are citation free.
Why should you attend:
It has been close to a decade since the US FDA published their Scope and Application guidance for CFR 21 Part 11. Since then, there have been numerous meetings between industry experts and FDA. These meeting addressed issues stemming from implementing the Part 11 regulations. In 2010 the FDA undertook a review of the inspection status of Part 11. The returned to the industry to reaffirm their audit approach to ensure that their Scope and Application guidance of 2003 will remain in effect and that their auditors would continue to audit for and enforce Part 11 in certain specific areas. Such audits would be known as "tag along audits" with specific audit focus on certain very critical aspects of good electronic documentation to ensure the authenticity and integrity of their data.
Such audits are already in progress and a significant number of citations have been issued in the past 6 months. Attend the webinar to familiarize yourself with this new audit approach for Part 11 and thereby increase your chances for a successful audit. The webinar has been designed to address the subtleties of Part 11 regulations with reference to the items that regulatory agencies are focusing on during their "tag along audit" strategy. Specifically, the 483s and Warning Letters pertaining to such audits will be examined for trends and strategies that your company should adopt will be discussed.
Areas Covered in the Session:
Predicate rules and Part 11/Annex 11 requirements overview
Dependencies between Predicate rules and Part 11/Annex 11
Similarities and differences between Part 11 and Annex 11