Validation and Part 11 Compliance of Computer Systems – 3 Hours Virtual Seminar

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

Learning Objectives:

Upon completing this seminar, participants will understand what is expected in Part 11 and Annex 11 compliance. You will learn how to plan for an FDA inspection of their software systems and avoid 483s and warning letters. Participants will learn how to implement a computer system using risk-based validation while reducing their costs. Participants will also be familiar with the requirements for local, SaaS, and cloud hosting systems. You will also learn and be informed how to protect their intellectual property and keep their records safe.

Areas Covered in the Session : 

• Understanding what is expected in Part 11 and Annex 11 inspections
• Avoiding 483s and Warning Letters
• Implementing a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
• Requirements for local, SaaS, and cloud hosting
• How to select resources and manage validation projects
• Right size change control methods that allows quick and safe system evolution
• Minimizing the validation documentation to reduce costs without increasing regulatory or business risk
• Writing test cases that trace to elements of risk management
• Protecting intellectual property and keep electronic records safe

Who Should Attend:

This CSV 3 hour webinar will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, bio-pharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

• Regulatory Affairs Departments
• QA/ QC Departments
• IT/IS Departments
• Software Managers
• Project Managers
• Software vendors and suppliers

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.