USFDA GMP Inspection Approach for Laboratory Control Systems

This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. This online course introduces laboratory controls, breaks down GMP Part 211, reviews method validation and out of specification results, and provides tips for laboratory notebooks. It also reviews requirements of laboratory equipment, gives insight on laboratory-focused, FDA systems-based inspections, and the common finding of non-compliance.

The course includes pre- and post-assessments, a downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all Web links discussed. At the conclusion of this session, participants will be able to:

  • Explain how to stay current and compliant with FDA regulations
  • Describe the Golden Rule on procedures
  • Describe the difference between GMP and GLP
  • Describe the minimum number of qualified personnel and supervisors to run quality control operations
  • Identify the requirements for proper record keeping and documentation in laboratory notebooks
  • Describe the GMP equipment requirements
  • Define method validation

Interactive Course includes:

  • A downloadable presentation for note-taking.
  • Learning reviews/assessments highlighting important points.
  • Reference materials and links to regulatory information.
  • An online resource handout as a quick reference for all the web links discussed.

CEUs are provided once you achieve an 80% passing grade and complete the evaluation.

Attendance suggested for:

  • Professionals who are new to the industry or have new work assignments that need to gain knowledge about the industry, its challenges and regulations.
  • Professionals with industry experience that want a refresher.
  • Suppliers and service providers to the industry, who design, construct, validate and finance facilities.
  • Individuals who support the industry through training, marketing, economic development and personnel placement.
  • Individuals with responsibility for: Analytical Procedures, Clinical / Investigational Products, Research and Development

Instructor

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