🎤  Joy McElroy |  📅  November 16, 2022   |  🕒  11 AM Eastern Time US

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


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.

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
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