Industries: Pharma / BiotechMedical Device

Validation of Computer Systems

Course Director: G. Raymond Miller, Ph.D.

Course Description - Course runs 9:00 to 5:00 both days

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.

Course Agenda

First Day

Computer Validation – General Overview

  • Computer Validation fundamentals – a walk-through of a complete validation of a small example system
  • Who needs to validate?
  • What is Computer Validation?
    • Core principles
    • Brief history of computer validation
  • Why is validation necessary and what regulations guide validation requirements?
  • Review of the computer validation references in regulations and guidances:
    • 21 CFR Part 211
    • 21 CFR Part 810
    • 21 CFR Part 11
    • Annex 11: Computerized Systems
    • Guidance: Q7A GMPs for Active Pharmaceutical Ingredients
    • Guidance: General Principles of Software Validation
    • Guidance: Computerized Systems Used in Clinical Investigations
  • When and how are systems validated?
  • Review of key FDA Warning Letters related to computer validation

Computer Validation Process and Deliverables

  • What is the SDLC (System Development Life Cycle) process?
  • How does computer validation fit into the SDLC?
  • What content must be covered?
  • What are the expected tasks and deliverables?
  • System/software specifications
  • Requirements options and documentation
  • How 21 CFR Part 11 applies to computer validation
  • Design Qualification (DQ) and vendor selection
  • Risk Assessment in computer validation
    • Where does it apply?
    • A walkthrough of the GAMP risk assessment process
  • Validation Plans and Master Validation Plans
  • Installation Qualification (IQ)
    • ­The five topics expected in IQ documents
  • Operational Qualification (OQ) and Performance Qualification (PQ)
    • ­Testing strategies and level of detail
    • How much testing is enough?
    • Examples of effective test cases and system errors discovered
  • SOPs required for system operation and maintenance
    • ­How they related to FDA Warning Letters
  • Validation Summary Reportse

Day 1 wrap-up

  • General questions and answers

Second Day

Overview of 21 CFR Part 11 (Part 11)

  • Background and purpose of Part 11
  • Overview of Part 11 (review regulation)
  • Review of the Part 11 implications in regulations and guidances:
    • 21 CFR Part 58 GLP
    • ­21 CFR Part 211 GMP
    • ­21 CFR Part 312 GCP (IND)
    • 21 CFR Part 810 QSR
    • Guidance: Part 11 scope and application (September 2003)
    • Guidance: Computerized Systems Used in Clinical Investigations
    • Guide to the Inspection of Pharmaceutical Laboratories
  • Review of Part 11-related FDA Warning Letters
  • Discussion of example systems and the evaluation of Part 11 Compliance decisions
  • Industry trends and approaches – the future of Part 11 issues
  • Interactive discussion of Part 11 issues and concerns (bring your questions)
  • Achieving and Maintaining Part 11 Compliance

GAMP-Specific Computer Validation Topics

  • The industry guidance for Good Automated Manufacturing Practice (GAMP)
  • How GAMP addresses the FDA's expectations for computer validation
  • GAMP 5 versus GAMP 4
  • How to transition to GAMP 5 from GAMP 4
  • A review of the supplementary GAMP guidances and where they apply

Auditing Computer Systems

  • Auditing GxP computer systems
  • Auditing suppliers of computer systems for GxP use
  • Auditing developers for customized systems
  • The general process for auditing computer systems
  • Variations that can save time and money
  • Review of an example audit checklist
  • Primary areas of focus (what to look for)
  • Examples of audit findings

Day 2 wrap-up

  • Interactive Discussion / Question and Answer Period
  • Additional CSV topics (TBD during course by attendees, "Parking Lot")
  • General questions and answer

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.

Testimonials

"This is an excellent course for anyone wanting to learn generally accepted validation practices." Sarah L., Document Specialist II, Mallinckrodt
"The Validation of Computer Systems course was very informative and engaging. The instructor was knowledgeable and well spoken." Laura S., Nordion
"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