Validation of Computer Systems

Available Locations


COURSE DETAILS

Course Description

This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.

Topics to be discussed include:

  • The regulatory expectations for computer validation
  • Relevant FDA warning letters
  • The tasks and deliverables expected for computer validation
  • Why validation processes vary so much
  • Strategies for practical, yet defensible computer validation
  • Sops required for system operation and maintenance
  • 21 CFR part 11 and it’s implications for common regulations
  • An active discussion of part 11 examples and audience questions
  • The implications of GAMP 5 on computer validation and how to transition from GAMP 4
  • Auditing GXP computer systems and suppliers

Who Should Attend

This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with FDA regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Learning Objectives

The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. The attendee will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.

Past Participants' Comments

"Ray was an excellent course director.  He made learning about computer systems validation a lot of fun.  I loved the open discussion involved during the course." Tushar G., Production Operator, IBM

"The Course Director managed to turn potentially dull subject into an interesting course.  Good balance between basics and in-depth subjects, accompanied by examples and anecdotes from current practice." Bas K., Senior Mfg Engineer, Brunel

"The Course Director was very knowledgeable and experienced. I would certainly recommend this course for anyone who might be interested in computer validation."
Robert R., Clinical Data Management, BSD Medical
"This course helped me understand the details of computer system validation…the ‘what, how and why.’ It gave me a framework from which to start the validation process." Deena G., Sr. Manager – Data Management Group, Sunesis Pharmaceuticals
"Overall an excellent course. It’s a significant accomplishment to deliver material of this nature in practical everyday terms." Maria L., Consultant, SAS Institute
"I had no background in CSV and I had no idea how to start the documentation of our software validation process according to the FDA compliance. Now I can start when I get back to Germany! Thank you to the Course Director. He spoke slowly and clearly to help me understand him. I am German and my English is not fluent, so this was very important." Brigitte R., Director HR/Project Manager, DoccuWare AG, Germany
"The course covered all the major parts of computer systems validation as well as the "why" of doing them. The Course Director could present to experienced and neophytes and make it interesting to all." Sandra D., LIMS Manager, Centocor R&D
"Validation is new to me and this course gave me an overall view of what it entails. I would recommend this course to others in my company who are in the IT department or others who are directly involved with computer systems." Linda M., Assoc. Product Safety Manager, Eisai
"Wish I had taken this course before I validated a system. The instructor was very knowledgeable." Daniel R., Senior Validation Specialist, Glaxo (GSK)
"The Course was informative and provided a good foundation for Computer Validation. I'd recommend it to anyone new to Computer Validation." Joe Y., Validation Consultant
"Course was superb! The Course Director was knowledgeable and his presentation was flawless. This was my first course with CfPIE and I will certainly look for additional courses relative to my specific expertise." Henri S,. Aventis
"Good Course. Well Presented!" Stewart S,. Optos
"Lot of information to cover but it was clearly articulated and very useful. Specific examples provided to illustrate the ideas were extremely helpful in ease of understanding." Michael H,. Manager IT, Introgen Therapeutics
"The vendor questionnaire for FDA Software application alone paid for the course. Well done!" Romeo P,. Johns Hopkins University

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