How to Prepare for a Tag Along Audit of CFR 21 Part 11.
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 familiarise 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 Part 11/Annex 11 related SOPs GDP related 483s and Warning letters Who Will Benefit: Project Managers Lead Engineers Software Engineers Documentation Managers Document System Control Personnel Contractor Consultants QA Regulatory Affairs R&D Manufacturing Engineering and IT personnel
Chinmoy is a seasoned Life Sciences professional. His expertise includes the design, delivery and validation of industry compliant computerised and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Quality by Design (QbD) and Quality Risk Management (QRM).
He has more than 35 years of hands on industry experience in directing the implementation, validation and obtaining "fit for use" certification of large biopharmaceutical manufacturing automation and IT systems. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11. He has a very broad experience in facilitating QRM sessions for large US companies and has provided them with consultant oversight to establish their Quality Risk Management plans.
His training sessions are unique in that he combines his field experience to explain the intricacies of applying the regulations. Such an approach of blending theory with practical applications has provided his trainees the necessary skills to lead regulatory efforts in their respective organisation.
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