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Who should attend A risk based approach to GxP Compliant Laboratory Computerized Systems
VP of IT, Director of IT, Quality Managers, Project Managers (for CSV / IT), Validation Specialists, Database Administrators, System Administrators, Directors / Senior Directors of Discovery, Directors / Senior Directors of Development
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Seminar Summary:

This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation. (see full course description)

 
 
 

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Training Course Syllabus:


Course Description

Laboratory Computerized Systems and data management operations are increasing in variety, sophistication and complexity in the GxP environment. Widespread reliance on these systems, along with their potential impact on data integrity, and the trend towards cost efficiency within companies, means that companies need achieve GxP compliance of laboratory computerized systems– within a reasonable budget and timeline. The wide diversity of these systems, coupled with their capability for networking, makes it impractical and inefficient to have single approach to achieve GxP compliance for all systems. For example, a High Performance Liquid Chromatography (HPLC) with a Photo Diode Array (PDA) detector is much more complex than a pH meter, and will require a correspondingly more detailed and complex implementation, control and maintenance approach.


Learning Objectives:

  • Examining the system life cycle and its applicability for most laboratory computerized systems
  • Identifying characteristics that distinguish various types of laboratory computerized systems
  • Developing a rationale for scaling activities and effort based upon risk, complexity, and novelty
  • Defining a strategy for supplier assessments, and the effective leveraging of supplier knowledge, experience, and documentation
  • Applying the GAMP® 5 Quality Risk Management (QRM) approach
  • Defining necessary operational and maintenance activities
  • Recommending an approach to system retirement
  • Leveraging deliverables and activities for very similar or identical systems

  • DAY 01(8:30 AM - 4:30 PM)

  • Lecture 1: Introduction and Background
  • Lecture 2: Quality Risk Management
  • Lecture 3: Life Cycle Approach
  • Lecture 4: Life Cycle Phases

  • DAY 02(8:30 AM - 4:00 PM)

  • Lecture 5: GxP Compliance
  • Lecture 6: Risks & Implementation of Systems
  • Lecture 7: Supplier Documentation & Services
  • Quiz: Jeopardy!!!!
  • Seminar Summary:

    This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation. (see full course description)

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