Computer System Validation and Part 11 Compliance

Why Should You Attend:

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.

Areas Covered in the Webinar:

• 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 Will Benefit:

This CSV 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, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications. Employees who will benefit include:

• Regulatory Affairs Professionals
• QA/ QC Personnel
• IT/IS Personnel
• Software Managers
• Project Managers
• Software Vendors and Suppliers

Joy McElroy
Principle Consultant, Maynard Consulting Company

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the 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. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, equipment qualifications, and performing technical writing.

With over 30 years total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing. Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device and biologics companies around the world.

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