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.
Upon completing this webinar, participants will understand what is expected in Part 11 and Annex 11 compliance. The 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. They will also learn and be informed how to protect their intellectual property and keep their records safe.
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
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.
Software vendors and suppliers
Duration: 180 Minutes
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
Upon earning a degree in Zoology at North Carolina State University, Joy 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 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 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy 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.