FDA Trends for Computer System Validation (CSV) Compliance and Enforcement (Virtual Seminar) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement” webinar has been added to from ResearchAndMarkets.com offer.

By the end of this session, participants will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

They will understand how to develop the most robust computer system validation compliance program, focusing on critical areas of concern to the FDA. Participants will have a good understanding of how to identify potential weaknesses and findings, as well as make recommendations to address and correct them through risk mitigation.

In particular, we will focus on best practices for validating FDA-regulated computer systems and achieving compliance with electronic records and electronic signatures (21 CFR Part 11). We will also provide current FDA trends, including a focus on data integrity issues in the industry, which will be illustrated with industry examples.

The seminar will cover what you need to do to prepare for an FDA audit, as well as the importance and steps needed to be certain that you have audited all vendors of regulated systems appropriately.

Why should you attend

Efficient and compliant computer system validation is essential for any organization regulated by the FDA. The FDA has established very specific requirements for achieving compliance and a very prescriptive set of enforcement measures to protect patient and/or consumer safety.

This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits, and gain insight into the level of enforcement associated with various findings, executive orders consent and warning letters. Examples from industry will be used as case studies to illustrate these.

It is vital for regulated companies to keep the pulse of the regulatory environment in order to strengthen system validation efforts, if necessary, to meet FDA expectations. It’s best practice to have a robust computer system validation, keep it running consistently, and document it thoroughly.

By maintaining a strong and consistent computer system validation program, companies can build trust with the FDA and consumers who rely on such oversight for their protection.

Who should attend:

  • Information Technology (IT) Analysts

  • IT developers

  • IT support staff

  • QC/QA managers and analysts

  • Clinical and scientific data managers

  • Compliance officers and auditors

  • Laboratory managers and analysts

  • Computer system validation specialists

  • GMP Training Specialists

  • Business Stakeholders Using FDA Regulated Computer Systems

  • Regulatory Affairs Staff

  • Consultants in the life sciences and tobacco industries

  • Interns working in the companies listed above

  • College students attending schools studying computer systems validation, regulatory affairs/issues (FDA-related), or any other discipline that involves meeting FDA regulatory requirements

Main topics covered:

  • FDA Regulatory Oversight

  • Computer System Validation (CSV)

  • System Development Life Cycle (SDLC) Methodology

  • Good “variable” practices (GxP) (good manufacturing practices (GMP), good laboratory practices (GLP), good clinical practices (GCP))

  • Categorization of GAMP 5 software

  • System Risk Assessment

  • Requirements, design, testing

  • Requirements Traceability Matrix (RTM)

  • Validation documents

  • 21 CFR Part 11 compliance (electronic records/signatures)

  • Preparation for audits

  • Most common problems with CSV

  • Best Practices


Carolyn (McKillop) Troiano has over 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA regulated industries.

She has worked directly or as a consultant for many large pharmaceutical and tobacco companies in the United States 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.

For more information on this webinar, visit https://www.researchandmarkets.com/r/biyir2

Gordon K. Morehouse