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Computer System Validation and Part 11 Compliance


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Who should attend?

Regulatory Affairs QA/ QC IT/IS Software Managers Project Managers Software vendors and suppliers

Details

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
  • How to select resources and manage validation projects
  • What are the "Right size" change control methods that allows quick and safe system evolution
  • How to minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • How to write test cases that trace to elements of risk management
  • How to protect intellectual property and keep electronic records safe

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
  • "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

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:

https://goo.gl/FHGoyE

 

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Prices

Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to audio recording of the webinar for 6 months. $219 Training CD MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499

Contact

Training Doyens
support@trainingdoyens.com

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