Learn valuable insights and strategies from industry experts.
FDA expects computer systems used in regulated work to be classified, risk-assessed, tested and validated so they do what they claim to do. This 90-minute data governance and computer system validation webinar explains those expectations in detail.
You'll walk through the SDLC approach to CSV, including its phases, sequencing, deliverables and documentation. You'll see how GAMP 5 classification and risk help set the right level of validation effort for in-house, configurable and custom systems, with best practices and pitfalls for laboratory systems.
The session also covers keeping systems validated, archival and retirement, setting up a data governance committee with a charter and clear roles, and applying project and change management throughout.
Validating a GxP system can be expensive, so the effort must match the system's risk and use. Weak governance puts data integrity at risk.
This session suits anyone who plans, runs, maintains or supports a GxP system in pharmaceutical, medical device, biotech or tobacco companies, including data owners and stewards, IT, QA/QC, validation, laboratory and compliance staff, and consultants.
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biotechnology, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling, Quality testing, 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 GxP system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and 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.
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