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Trends In FDA Compliance And Enforcement For Regulated Computer Systems
This Webinar is over| Date | Nov 5, 2018 |
| Time | 01:00 PM EDT |
| Cost | $213.00 |
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Online
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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 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.
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and 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 implementation of any computer system governed by FDA regulations, or if you are developing, configuring, maintaining or supporting such a system.
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Why 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.
Who Can Also Attend:
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.
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and 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 implementation of any computer system governed by FDA regulations, or if you are developing, configuring, maintaining or supporting such a system.
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Why 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.
Who Can Also Attend:
- Data “Owners”
- Data “Stewards”
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors of Computer Systems Regulated by FDA (hardware and software)
- Anyone in the pharmaceutical, biotechnology, medical device, e-liquid, e-cigarette, cigar or other FDA-regulated industries.
- Any vendor of hardware or software that serves the above industries.
- Any company involved in FDA-regulated company audits or compliance (consultants).
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