Duration: 90 Minutes


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All Regulatory Agencies are entitled to come in to any company involved in clinical trials and review documentation supporting procedures and computerized systems, in as part of an Inspection. The most common regulations that will form the back-ground to an inspection with regards to Clinical Trials, are those released by ICH and FDA. The aspects of a company that need attention in the run up to an inspection are the documentation related to people and their roles, responsibilities and training; procedures their current versions, approval signatories and related dates and computerized systems utilized within the trial processes, and all the documentation that supports their validated state.

This course provides an understanding of the various activities that need to be completed in preparation for a Regulatory Inspection targeting one of the computerized systems that were utilized during a clinical trial. It is vital to prepare adequately for a regulatory inspection to limit the findings documented by the inspectors.

Areas Covered in the Session : 


  • What happens during an inspection?
  • The component parts of an IT system
  • Regulatory Inspection expectations and examples of findings
  • Overview of Computer System Validation
  • Good Document Practice including archiving
  • Inspection preparation
  • Inspection behaviours

Who Should Attend:

  • Quality Assurance Teams
  • Trial Management Teams
  • Data management Teams
  • Clinical Research Associates
  • Project Managers
  • IT staff who may be called upon as System Owners or Programmers
  • Clinical Trial Data Trainers
  • Clinical Trial Data Managers
  • Documentation Teams

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.