Project Management Best Practices for Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment (i.e., the system “touches” product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.

This course will describe the best practices for managing such a project, including “who” should be responsible for tasks, “how” the documentation should be accomplished, and “what” specific criteria will be used to define success. FDA guidelines are very specific in terms of how this is to be done.

Areas Covered in the Session :

• Project planning, execution and management concepts
• GxP Predicate Rules
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC)
• Risk-based approach to validation
• GAMP V approach to system categorization and validation
• Implementation and validation of systems in compliance with FDA
• Roles, responsibilities and training
• Documentation required for FDA compliance
• Maintaining a system in a validated state
• Ratio of system cost to compliance with FDA
• SOPs required for supporting a validated system
• Industry Best Practices
• Interactive Q&A

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. Examples of who will benefit from this webinar include: 

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Consultants

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. 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. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.