Effective and Practical use of FMEA For Risk-Based Approach to Computer Systems Validation

Duration: 90 Minutes
Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. One way to avoid these issues is to employ a common risk-prevention tool called Failure Mode and Effects Analysis (FMEA). FMEA will help you focus on your most significant risks, allowing you to more efficiently and effectively validate your computer systems.
FMEA for Risk Prevention
Instructor: Joy McElroy
Product ID: 503901
Objectives of the Presentation
By attending this interactive, 90-minute online session, you will…
  • Understand what Failure Mode and Effects Analysis (FMEA) is and how to conduct one
  • Apply FMEA to customized and "commercial-off-the-shelf" (COTS) systems within a GxP environment
  • Develop software validation strategies that incorporate FMEA as a tool to identify critical compliance items while keeping resource constraints in mind
  • Use FMEA to continuously monitor and improve your systems
Why Should you Attend
Professionals who attend this training will be equipped to present FMEA as a tool for scoping computer systems validation efforts to ensure that resources are focused on the most critical areas of risk. At its core, FMEA is designed as a methodology to evaluate a system, design, process, or service for possible ways in which failures can occur. As such, it is a perfect tool to validate computer systems and ensure compliance. This course will demonstrate how an FMEA can be used to scope computer validation efforts on the most critical business and compliance items.

Who will Benefit
  • Anyone involved the validation, use, and maintenance of regulated computer systems within GxP environments
  • Laboratory Data Systems professionals
  • Quality Assurance teams
  • Regulatory Affairs professionals
  • Validation and IT teams
  • Quality & Regulatory Professionals
  • Quality System Auditors
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Any individual whose job function includes responsibility for the validation, use, and maintenance of regulated computer systems
Topic Background
The FDA requires that software systems used for quality purposes in place of paper records be validated for their intended use [Title 21 CFR Part 820(i)]. This means that when using COTS systems, companies must verify that the software is configured correctly to meet their business needs. Even if you are intending to do a relatively vanilla implementation you need to have documented evidence verifying that the system was correctly installed and configured correctly for your intended use. Performing software validation right the first time will save medical manufacturers both time and money now and in the future.
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Instructor Profile:
Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.


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