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Thursday, November 30, 2017
1:00 PM - 2:30 PM
1:00 PM - 2:30 PM See all dates and Times
http://bit.ly/2hKbKGm
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.
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:
• 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
• What are the requirements for local, SaaS, and cloud hosting
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
• Requirements for local, SaaS, and cloud hosting
• How to select resources and manage validation projects
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.
WHO WILL BENEFIT
• Regulatory Affairs
• QA/ QC
• IT/IS
• Software Managers
• Project Managers
• Software vendors and suppliers
For more details click on this link:
http://bit.ly/2hKbKGm
Email: [email protected]
Toll Free:+1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
PRICE :$199
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:
• 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
• What are the requirements for local, SaaS, and cloud hosting
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
• Requirements for local, SaaS, and cloud hosting
• How to select resources and manage validation projects
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.
WHO WILL BENEFIT
• Regulatory Affairs
• QA/ QC
• IT/IS
• Software Managers
• Project Managers
• Software vendors and suppliers
For more details click on this link:
http://bit.ly/2hKbKGm
Email: [email protected]
Toll Free:+1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
PRICE :$199
