Trends In FDA Compliance And Enforcement For Regulated Computer Systems
About this course
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Training Duration: 60 Minutes
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Pharmaceutical, biological, vaccine, medical device, animal health, 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. 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 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.
Areas Covered in the Session:
- 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 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 FDA in industry, how companies have responded, and identify the best practices
Why Should You Attend:
Upon completion of this session, attendees 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 the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any computer system governed by FDA regulations, or if you are developing, configuring, maintaining or supporting such a system.
Who Should Attend:
- Computer System Validation Specialists
- Information Technology Professionals
- Data Analysts and Managers
- Automation Analysts and Managers
- QC/QA Analysts and Managers
- Laboratory Analysts and Managers
- Compliance and Audit Managers