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Validity : 21st Apr'24 to 01st May'24
Best Practices for Preparing for an FDA Computer System Validation Audit
- Describe the key components and importance of regulatory audits of validated computer systems
- Discuss best practices for preparing for a computer system validation audit by a regulatory agency
- Provide examples of the documentation you can prepare to minimize risk and ensure your audit is successful
- Discuss best practices for participating in a computer system validation audit by a regulatory agency
- Provide examples of what you can do during the audit to minimize risk, time and overall cost
- Discuss best practices for developing a positive relationship with regulatory agency auditors and building a reputation for preparedness, thoroughness and integrity
- Interactive Q&A Session
Overview of the webinar
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.
Applying best practices will ultimately result in minimizing the time and cost of regulatory audits, and the impact on operations and productivity. While there are many sources of information to help you develop a good validation program, this course will narrow down the most overall cost-effective approach that is tried and true.
It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner.
Who should attend?
- Compliance and Audit Managers
- Data Owners
- Data Stewards
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Any Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Why should you attend?
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations or if you are maintaining or supporting such a system.
Upon completion of this session, attendees will have an understanding of computer system validation audits and the guidance needed to develop an internal program for responsiveness. They will understand the steps for creating one, along with the key documentation associated with managing the process and presenting information and providing responses to agency auditors. The attendees will have a good grasp of how to defend their computer system validation efforts and the confidence needed to successfully prepare for and respond to audit questions.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.