The Seminar will focus on the pivotal realm of 21 CFR Part 11 - electronic record/electronic signature (ER/ES) compliance within FDA-regulated computer systems. Gain insights into crafting a robust company philosophy, seamlessly integrating ER/ES capabilities into your computer system validation program, and formulating tailored plans for individual systems.
Since its inception in the late 1990s, FDA's 21 CFR Part 11 has shaped the landscape of electronic records in regulated industries. However, the path to implementation success has been diverse. Specific limitations come to the forefront when harnessing ER/ES capabilities, including the strategic elimination of print capability to thwart decisions based on paper records. Rigorous user identification processes and stringent password management are imperative, ensuring the security of the electronic signature.
A cornerstone of compliance lies in the precise delineation of the electronic signature's meaning. Whether signifying the execution, recording, review, or approval of work, clarity is paramount. Attestations must confirm appropriate segregation of duties, where individuals responsible for recording results differ from those reviewing or providing final approval.
Recognizing the variability in ER/ES capabilities, our seminar advocates for an approach tailored to each case, aligned with associated guidance risks. Uncover the key to harmonizing your company's policies and procedures, explicitly outlining responsibilities, and offering guidance on ER/ES implementation.
In a dynamic regulatory landscape, adaptability is paramount. As the FDA undergoes transformations influenced by myriad factors, your company must be equipped to evolve. Our seminar arms you with the knowledge to navigate emerging technologies, streamlining operations while mitigating inadvertent complexities that may encumber your computer system validation program.
Since its inception in the late 1990s, FDA's 21 CFR Part 11 has shaped the landscape of electronic records in regulated industries. However, the path to implementation success has been diverse. Specific limitations come to the forefront when harnessing ER/ES capabilities, including the strategic elimination of print capability to thwart decisions based on paper records. Rigorous user identification processes and stringent password management are imperative, ensuring the security of the electronic signature.
A cornerstone of compliance lies in the precise delineation of the electronic signature's meaning. Whether signifying the execution, recording, review, or approval of work, clarity is paramount. Attestations must confirm appropriate segregation of duties, where individuals responsible for recording results differ from those reviewing or providing final approval.
Why Should You Attend
Immerse yourself in a comprehensive exploration of FDA's 21 CFR Part 11 guidance, unravelling the intricacies of ER/ES application in FDA-regulated computer systems. This seminar is your gateway to developing a foolproof validation strategy, substantiating the system's functionality throughout its lifecycle, from conception to retirement.Recognizing the variability in ER/ES capabilities, our seminar advocates for an approach tailored to each case, aligned with associated guidance risks. Uncover the key to harmonizing your company's policies and procedures, explicitly outlining responsibilities, and offering guidance on ER/ES implementation.
In a dynamic regulatory landscape, adaptability is paramount. As the FDA undergoes transformations influenced by myriad factors, your company must be equipped to evolve. Our seminar arms you with the knowledge to navigate emerging technologies, streamlining operations while mitigating inadvertent complexities that may encumber your computer system validation program.
Course Content
DAY 1 (10 AM to 3 PM)- Identifying “GxP” Systems
- Current state of CSV approach based on FDA requirements
- Understanding Computer Software Assurance
- Agile approach to System Development Life Cycle (SDLC)
- Cloud computing and Software as a Service (SaaS) systems
- Agile continuous validation approach
- Policies and procedures needed to support your validation process
- Q&A
- 21 CFR Part 11/Annex 11
- Strategic Approach to ER/ES Compliance
- Policies and Procedures to Support GxP Compliance with 21 CFR Part 11
- Computerized Systems for Data Integrity
- Training and Organizational Change Management Best Practices
- Industry Best Practices and Common Pitfall
- Cost Reduction Without Increasing Regulatory or Business Risk
- Q&A
Speakers
Carolyn TroianoCSV & FDA Compliance Expert
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
