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 L McElroy
Product ID: 503169
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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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off site training to pharmaceutical and biotech companies throughout the United States, Canada, and the world.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
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