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

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.

Why You Should 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.

Areas Covered in the Session : 

• 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

Who Should Attend:

• 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
• Everyone whose job function includes responsibility for the validation, use, and maintenance of regulated computer systems within GxP environments

Course Director: JOY MCELROY

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 and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence. Her knowledge, experience, 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, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance. 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. 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.