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

View Course Agenda




Past Participants' Comments

“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

“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, 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