Project management principles can be used to ensure that all efforts to develop, configure, implement, test, validate and maintain a computer system is compliant-specific in terms of how this is to be done.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.specific in terms of how this is to be done.
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. specific in terms of how this is to be done.
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.
Why Should You Attend?
You should attend this seminar if you are responsible for planning or executing the implementation, validation, and/or ongoing management of a computer system governed by FDA regulations. It is critical that the project is managed in line with the system development life cycle (SDLC) requirements that FDA has set forth for all computer systems used in the manufacturing, testing, distribution and tracking of a regulated product, such as a drug or biologic.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized, and exercising good project management principles is at the core of achieving the appropriate compliance to cost ratio.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available for managing projects related to systems regulated by FDA.
- 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
Business Systems Analyst ,
Estes Express Lines
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.
- Information technology managers and analysts
- Production managers and analysts
- QC/QA managers and analysts
- Clinical data managers and scientists
- Compliance managers
- Lab managers and staff
- Automation analysts
- Computer system validation specialists
- GMP training specialists
- Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, training and audit
- Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
Professionals in the following industries may also benefit from the content:
- Medical Diagnostics
- Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
- Animal Health
- Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm