- Global Pharma News & Resources
20-May-2019 - 20-May-2019

Current Trends in FDA Compliance and Enforcement for Computer System Validation (CSV)


Pharmaceutical, biological, vaccine, medical device, tobacco and other companies regulated by FDA must be vigilant in understanding compliance and enforcement by the Agency as it relates to computer system validation (CSV). In all cases, regulated companies should do the right thing and have robust computer system validation programs that are well executed and documented in order to meet the strict guidelines set forth by the FDA.
At any given time, there will be areas the FDA focuses on more heavily, usually due to adverse events, or other issues that crop up within the regulated industries. In response, they may come down harder (or softer) in their enforcement practices.
The key is to understand what the compliance requirements for computer system validation entail, how best to meet these strategically and tactically, and how best to position your organization to anticipate actions and enforcement by the Agency.

Why should you attend this webinar?

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to an industry that was initially preventing companies from embracing the technology.
This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Areas Covered in the Session:

This webinar will cover the following key areas:

  • Describe the various components of computer system validation compliance required by FDA

  • Understand the most critical aspects of computer systems to be scrutinized by FDA during reviews and audits

  • Discuss ways to anticipate and prepare for FDA scrutiny

  • Determine how to identify and select the best course of action taken when responding to an FDA finding, warning or consent decree

  • Describe some of the key factors that influence the degree of FDA enforcement for computer system validation programs in the GxP regulated industries

  • Discuss ways to apply basic computer system validation principles to ensure that in all cases a regulated company is prepared for emerging trends

  • Provide examples of enforcement actions by the FDA in industry, how companies have responded, and identify the best practices

  • Q&A

Who can Benefit:

Within FDA-regulated companies, people in the following roles will benefit from this presentation:

  • Computer System Validation Specialists

  • Information Technology Professionals

  • Automation Analysts and Managers

  • QC/QA Analysts and Managers

  • Laboratory Analysts and Managers

  • Clinical Data Analysts and Managers

  • Manufacturing Analysts and Supervisors

  • Supply Chain Managers and Analysts

  • Compliance and Audit Managers

  • GMP Training Specialists

  • Regulatory Affairs Professionals

  • Business Stakeholders/Subject Matter Experts

  • Business System/Application Testers

Anyone who is involved in the development, testing, manufacturing, storage, handling, and distribution of product must understand and conform to FDA requirements for computer system validation.
Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.

Speaker Profile:

Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation.

Contact Info:

Compliance Key



Phone: +1 717-208-8666