The Calibration in the Pharmaceutical industry; Fundamental, Concept and Risk based calibration approach

Engineering and Validation
Operations
Quality
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  1. Program Description
  2. Target Level
  3. Description
  4. Objectives and Expected Results
  5. Others Training Materials
  6. Target group
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Duration
Course fee
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Program Description

Topics to be covered with this training includes:

  • Calibration Fundamental Definitions
  • Risk-Based Calibration
  • Introduction to Calibration Master Plan
  • Measuring & Test Equipment and Classification (Criticality Assessment)
  • Building effective Calibration Management System (CMS)
  • Calibration Requirement and Change Control
  • Calibration SOP’s and documentation requirements

Target Level

Description

Objectives and Expected Results

  • Participants will take Idea about all definitions and abbreviation used in Calibration and specifically in the Pharmaceutical Industry
  • Participants will be able to build the calibration system and relevant documentation
  • Participants will have good knowledge for traceability of calibration according to reference standards
  • Participants will have an idea for differences between Verification, Testing, and Calibration as different tasks under Validation umbrella
  • Participants will take the idea of how to incorporate Calibration as part of total Quality Management System
  • Participants will have knowledge of how the calibration is critical on the product
  • Participants will have Idea for utilizing a computerized system scheduling program
  • Participants will take an idea about the SOP’s required and cross functioning documents required to achieve proper control and data integrity that may be raised by regulatory Inspecto

Others Training Materials

Workshop, Sheets and case studies paper will be conducted and implemented during training

Target group

  • -

    Trainer Languages English/Arabic

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232