RAPS: This course has been pre-approved by RAPS as eligible for up to 4.0 credits towards a participant's RAC recertification upon full completion.
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.
In particular, we will focus on best practices for validating computer systems regulated by FDA and meeting compliance with electronic records and electronic signatures (21 CFR Part 11). We will also provide current FDA trends, including a focus on data integrity issues in industry, which will be illustrated through industry examples.
The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.
Why You Should Attend
Effective and compliant computer system validation is critical to any FDA-regulated organization. FDA has set forth very specific requirements for meeting compliance, and a very prescriptive set of enforcement actions to protect patient and/or consumer safety. This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits, and gain insight to the level of enforcement associated with various findings, consent decrees and warning letters. Examples from industry will be used as case studies to illustrate these.
It is vital for regulated companies to maintain a pulse on the regulatory environment in order to fortify system validation efforts, as necessary, to meet FDA expectations. It is the best practice to have a robust computer system validation, continue executing against it consistently, and documenting it thoroughly. By maintaining a strong and consistent computer system validation program, companies can further build trust with FDA and the consumers who rely on such oversight for protection.
Key Takeaways:
- Understand the latest FDA trends in CSV compliance and enforcement
- Learn risk-based validation strategies for efficient compliance
- Master data integrity principles (ALCOA+) and audit readiness
- Address challenges with cloud-based systems, AI, and automation
- Gain practical insights from real-world case studies
This live training seminar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of participation for attendee training records
- Q/A Session
Course Content
Course Provider
Carolyn (McKillop) Troiano,
IT Program Manager and FDA Compliance Consultant ,
Smart Resources, Inc.Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
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.
Who Should Attend
This training is designed for professionals in FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and healthcare. It is ideal for:
- Quality Assurance (QA) & Compliance Professionals - Ensuring adherence to FDA regulations and industry best practices.
- Regulatory Affairs Specialists - Staying up to date with evolving FDA enforcement trends and expectations.
- IT & Software Validation Teams - Implementing effective CSV strategies for computerized systems.
- GxP System Owners & Administrators - Managing compliance for validated systems in pharmaceutical and medical device environments.
- Auditors & Inspectors - Understanding common FDA findings and preparing for inspections.
- Manufacturing & Operations Managers - Ensuring compliance in automated manufacturing and data-driven environments.
- R&D and Clinical Teams - Maintaining compliance in electronic record-keeping and software validation.
This course is essential for anyone involved in validating, maintaining, or auditing computer systems in regulated industries. Would you like any customization based on a specific audience or industry focus?
