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.
This Computer System Validation Training course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar instructor will:
Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
Understand what is expected in Part 11 and Annex 11 inspections
Avoid 483s and Warning Letters
Learn how to buy COTS software and qualify vendors
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Who will Benefit:
This CSV Training Course 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.
Software vendors and suppliers
Use coupon code NB5SQH8N and get 10% off on registration.