How to Transition from Traditional CSV to CSA: Practical Migration Plan, Templates & Risk Strategy

Description:

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where newer technologies are becoming prevalent.

It is time to embark on replacing classic CSV with Computer Software Assurance (CSA), the draft guidance from FDA in 2022, to validate our FDA-regulated systems. This transition has the promise of both greater compliance and efficiency, while companies continue to deliver quality products to meet the needs of the consumers by putting newer, more innovative, safer, and more effective products in their hands, all of which are key focus areas for FDA.

We can begin using some of the CSA principles today. This is provided we adequately explain their use and defend the tie-in to Part 11, data integrity, the Quality Management System (QMS) and other relevant documents and programs.

In this webinar, we’ll provide an overview of the transition process in going from CSV to CSA. We’ll then dive into a step-by-step guide for the transition that can be done by any company. The transition steps, related documents and other artifacts and the potential issues to watch out for will be laid out very carefully.

The webinar will include a Q&A session. There is also an Appendix at the end of the slide deck that provides an example of performing this transition for Labware Laboratory Information Management System (LIMS). This is a typical system used by many companies in industry and provides good insight as to the detailed information needed to complete your validation effort, following CSA.

Why Should You Attend:

Providing safe and effective medical devices, drugs, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about projects going on in industry and at FDA that take advantage of newer technologies and innovations.

In this webinar, you will learn just how to transition your validation work from classic Computer System Validation (CSV) to Computer Software Assurance (CSA), based on the 2022 draft guidance from FDA. You can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative products that will drive industry over the coming years.

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 development, implementation or validation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with these technologies quickly and in compliance with FDA.

Areas Covered in the Webinar:

During the webinar, we will discuss the following:

• Understand current regulatory trends in industry for compliance and enforcement
• Understand how to determine whether a computer system requires validation and is “GxP.”
• Understand the true validation principles, first set forth in 1983
• Learn about a strategic approach to performing validation consistently across systems in the enterprise
• Learn step-by-step how to transition your validation program from CSV to CSA
• Learn about the changes in GAMP®5, 2nd Edition vs. the original GAMP®5
• Understand the best practices for planning a validation effort
• Learn about validation testing and how CSA can provide an easier pathway
• Understand the documentation that remains required by FDA
• Learn the concepts about 21 CFR Part 11 compliance for electronic records and electronic signatures
• Understand the concepts of data integrity as expressed in the “ALCOA+” principles
• We’ll cover industry best practices to ensure the transition is smooth
• Q&A

Who Will Benefit:

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.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers & 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
• Risk Management Professionals
• 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
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in internal inspection
• Software company employees, contractors, and consultants engaged in development, testing, and support of computer software used in the life science industries

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects.

Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA’s Guidance for Electronic Records and Electronic Signatures. During her career she has provided training, including CSV, 21 CFR Part 11, Data Integrity, and many other related compliance topics of interest to the life science industries.

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