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Computer System Validation and Part 11 Compliance - Webinar


2017, November 30

Clinical, Food » Training, Webinar


Overview: 
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.

Why you should attend: 
Upon completing this course participants should:
• Understand what is expected in Part 11 and Annex 11 inspections
• How to avoid 483s and Warning Letters
• How to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds

Areas covered:
• 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

Who will benefit: 
• Regulatory Affairs
• QA/ QC
• IT/IS
• Software Managers
• Project Managers
• Software vendors and suppliers
Learning objectives: 
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.

For more detail please click on this below link:
www.trainingdoyens.com


Venue

Internet - webinar

Organizer

Phone: +1-720-996-1616
Visit organizer website



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