Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
152 Witherspoon St.
Princeton, NJ 08542
P: 609.683.0756
F: 609.683.0758

Validation Compliance Personnel Training

IVT Conference: Session 26
Validation Compliance Personnel Training: Ignore it at your Own Risk

Len Grunbaum, Partner, Practical Solutions Group, LLC

Someone once said that “The greater the ignorance the greater the dogmatism.”  We see the truth of this every day in the validation compliance arena.  People with little or no knowledge or understanding of business concepts, technology and/or the regulatory environment have incorrect and fixed views on what validation is and how to apply its precepts.  The effect is that impractical decisions are being made and organizations are doing things that they need not do and spending time and money on things they need not spend.  This session will counter these often-seen trends by providing the attendees with practical suggestions regarding the qualifications and training that one should possess before making sound/practical decisions in the validation arena.  The session will also include discussion of the risks that occur when unsound or impractical actions are taken.

I. The first component of the session will

  • Identify the areas of importance – good business practice/risk management, technology, the regulatory environment – when dealing with the subject of computer systems validation;
  • Specify what issues vis-à-vis good business practice/risk management, technology and the regulatory environment are most relevant to the issue of computer system validation;
  • Identify training that can be provided to validation practitioners and supporting staff (e.g., IT, QA) to maximize the soundness and practicality of decisions.

II. The second component of the session will

  • Be an interactive workshop which will provide an opportunity for the attendees to explore the risks and discuss impacts of cases in which unsound/impractical decisions were made due to a lack of understanding of good business practice/risk management, technology, the regulatory environment and/or lack of appropriate qualifications.
  • Quality Assurance Managers and Staff
  • Validation/Validation Compliance Managers and Staff
  • Validation Consultants
  • IT Managers and Staff
  • Data Management personnel
  • Individuals responsible for groups/departments that have frequent validation needs