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Validation of Computer Systems

  March 31, 2016  
Center for Professional Innovation & Education, Inc., Malvern, PA
August 15 & 16, 2016

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
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Dr. G. Raymond Miller is President of Miller Regulatory Consulting (MRC). His company focuses on compliance management and execution in computer system validation and technical services.

Prior to founding MRC, Mr. Miller co-founded Cetan Technologies, Inc. There, he served as Vice President and Chief Technical Officer; developing a practical, yet defensible approach to computer system validation and 21 CFR Part 11 compliance. He also provided primary regulatory oversight and training to consultants, created the firm's product-development department and developed the first automation-assisted, nonintrusive computer-system validation testing.

In addition to this experience, he has also held senior-level computer-validation and information-systems positions with AAI, Alcon Labs and Mary Kay Cosmetics.

Dr. Miller received both his Ph.D. in Chemical Instrumentation and his M.A. in Analytical Chemistry from the University of Cincinnati. He received his B.S. in Chemistry from Florida Atlantic University.

Deadline for Abstracts: n/a
E-mail: info@cfpie.com
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