Overview:
As a 'GxP'system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.
This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.
We will also cover the importance of maintaining the documentation from every computer system validation effort in a 'current'state.The system must be maintained in a validated state throughout its entire life cycle, and the accompanying validation documentation must also be maintained.
As a 'GxP'system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.
This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.
We will also cover the importance of maintaining the documentation from every computer system validation effort in a 'current'state.The system must be maintained in a validated state throughout its entire life cycle, and the accompanying validation documentation must also be maintained.
Speaker
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 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
- This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
