This Computer System Validation Training 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.
WHY SHOULD YOU ATTEND
Upon completing this course participants should:
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.
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