Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

MessageThis Webinar is over
Date Oct 1, 2018
Time 01:00 PM EST
Cost $213.00
Online
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FDA requires all regulated companies to ensure structured data files and unstructured data files are managed in compliance with the Agency’s requirements.  This requires each company to evaluate their computer system vendors for this purpose adequately.  While the vendor is not obligated to provide a system that meets FDA compliance, the company purchasing a system must understand the vendor’s practices and be able to ensure the vendor is suitable for their environment.  The company then has to validate the system in compliance with FDA.

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:

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.

Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing or tracking processes).  Such a system must be validated under FDA guidelines for computerized systems and documented accordingly.

This course will describe the best practices for ensuring that any vendor hired to participate in the development, implementation or maintenance of an FDA-regulated computerized system meets the existing government regulations, along with any policies, procedures, and guidelines in effect at your organization.

We will discuss "who" should be responsible for such tasks and "how" the audit should be conducted.  FDA guidelines are very specific concerning how this is to be done, and a checklist can help ensure you meet them.
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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