FDA-Regulated Computers CSV 2018

Overview:

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Why should you Attend: This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.

Areas Covered in the Session:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good"Variable" Practice (GxP) (Good Manufacturing
Practice (GMP), Good Laboratory Practice, Good Clinical Practice (GCP)
• Validation Planning
• GAMP 5 System Classification

Who Will Benefit:

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors

Speaker Profile
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.