The Challenges of an Effective Change Control Program and How to Address OOS Results 2017

  • 17-18 Aug 2017
  • DoubleTree by Hilton Hotel San Diego Downtown, CA, United States

Description

Topics
  • When change control needs to be implemented and the main items it should cover
  • Current regulatory requirements for change control
  • What are the typical industry challenges associated with change control procedures?
  • What are the major sections that need to be included in a change control procedure?
  • What are the most common deficiencies cited by regulatory auditors when auditing change control programs?
  • The benefits that a well-controlled change control process can provide
  • When change control needs to be implemented and the main items it should cover
  • Current regulatory requirements for change control
  • What are the typical industry challenges associated with change control procedures?
  • What are the major sections that need to be included in a change control procedure?
  • Typical evaluation methods used for determining probable cause such as fault tree, fish diagrams
  • Current FDA Guidance for the investigation of Out of specification results (OOS)
Who should Attend
  • Quality Control
  • Quality Assurance
  • Production
  • Manufacturing
  • Laboratory Personnel
  • Regulatory
  • Equipment Vendors
  • Management

Past Events

Important

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Event Categories

Business: Operations, Quality assurance
Education: E-learning, Education Technologies & Methods, Higher education, Preschool , Primary and Secondary Education, Training
Health & Medicine: Medical laboratories

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