4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs

Computer system validation (CSV) 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 has been regulating CSV for more than 30 years now. The requirements ensure that any computerized system used for collection, analyzing and/or reporting data has been taken through a thorough all phases of planning, implementation, integration, testing and management.

Back in the year 1997, the FDA established guidelines on Electronic records and electronic signatures (ER/ES) which were disseminated through 21 CFR Part 11. This code of regulations describes the basic requirements for validating and documenting ER/ES capability in systems used within an FDA-regulated environment.

In the early 2000s, FDA urged industry to take responsibility and begin assessing all regulated computer systems based on risk. This came into being as the FDA recognized they could not inspect every computer system at every regulated company. The level of potential risk would form the basis for each company’s approach to developing a validation approach and rationale as part of the planning process should the system fail to operate properly. The five key components would include: system size, complexity, business criticality, GAMP 5 category and risk rating. These would determine the scope and robustness of testing required ensuring data integrity and product safety.

From the FDA’s CSV inspections and audits given the focus on data integrity in the recent years, the importance for compliance of systems used in regulated industries has become paramount. This would include all systems that “touch” product, meaning they were used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data must be managed and maintained with integrity throughout their entire life cycle. This would include databases, and unstructured data, documents, spreadsheets, presentations, and images, audio and video files, amongst others.

Through this webinar, we will explore the best practices and strategic approach for evaluating computer systems for FDA-regulated activities. We will also learn to determine the level of potential risk or threat, should the system fail with regard to data integrity, process and product quality, and consumer/patient safety. We will take a detailed view of System Development Life Cycle (SDLC) approach to validation. Risk assessment tools will be examined, and will also discuss 21 CFR Part 11. We will gage the importance of managing electronic records and signatures appropriately using relevant examples.

We will evaluate all essential policies and procedures, including supporting documentation and activities that must be established and followed to ensure compliance. This webinar will deliver an overview on best practices to prepare for an FDA inspection. This session will also touch on the significance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Overall, you will learn to leverage industry best practices using risk assessment tools with attention to data integrity to support all your GxP work ensuring compliance.

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.

  • Learn how to identify “GxP” Systems
  • Discuss the Computer System Validation (CSV) approach based on FDA requirements
  • Learn about the System Development Life Cycle (SDLC) approach to validation
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Understand how to maintain a system in a validated state through the system’s entire life cycle
  • Learn how to assure the integrity of data that supports GxP work
  • Discuss the importance of “GxP” documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Know the regulatory influences that lead to FDA’s current thinking at any given time
  • Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
  • Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
  • Learn how to best prepare for an FDA inspection or audit of a GxP computer system
  • Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
  • Interactive Q&A Sesison

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Who should attend this webinar include:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Specialists and Managers
  • Supply Chain Specialists and Managers
  • Regulatory Affairs Specialists
  • Regulatory Submissions Specialists
  • Clinical Data Analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers

membership
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance