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Calibration Management: A Robust, Cost Effective Approach U
Calibration Management:  A Robust, Cost Effective Approach U
Calibration Management: A Robust, Cost Effective Approach Using the GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management
Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure success, calibration should be managed effectively, by appropriately qualified and competent personnel. This online course provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance.

The course will describe a system of calibration management, which defines what needs to be done, when, by whom, and why, as well as identify regulatory requirements and business benefits.This course is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their knowledge of GAMP5. The course includes pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and online resource handouts as appropriate for quick reference.

Immediately apply the course learning objectives with an electronic download of the ISPE GPG: Calibration Management, 2nd Ed.

Course Modules/Learning Objectives

Module 1: Introduction to Calibration Management

  • Identify and explain key concepts and terms.
  • Review the GAMP® GPG Guide and discuss regulatory requirements.
  • Demonstrate that the correct management of Calibration will support process to ensure data integrity, product quality and patient safety.
Module 2: A Risk-Based Approach to Calibration Management

  • Review the project activities, roles and responsibilities.
  • Discuss Critical Risk Assessment (CRA) considerations.
  • Identify effective change management techniques that are presented in the guide.
  • Review impact assessments for changes affecting calibrated systems.
  • Review calibration management software details that are an integral part of calibration management.
Module 3: The Project Phase in the ISPE GAMP® Good Practice

  • Review the project activities, roles and responsibilities.
  • Discuss the process and importance of instrument tagging and identification.
  • Identify a recommended process for instrument and supplier selection.
  • Review commissioning and qualification details in the project phase.
Module 4: The Operational Phase in the ISPE GAMP® Good Practice

  • Review the operational phase of the GAMP® GPG Guide.
  • Discuss key documentation requirements in the operational phase.
  • Explore the basics of electronic records and signatures that relate to calibration.
  • Explore training and decommissioning.
Module 5: Documentation and Auditing

  • Discuss key regulatory requirements.
  • Review supplier auditing best practices and procedures.
  • Explore current regulatory expectations.
  • Review calibration certificates.
Module 6: Measurement Uncertainty and Traceability

  • Provide an introduction to basic terminology and concepts in measurement uncertainty and traceability.
  • Review a practice example of application of traceability.
  • Explore the relationship between measurement uncertainty and traceability.
  • Discuss errors of uncertainty.
Attendance Suggested for:

  • Calibration technicians, control engineers, instrument engineers, control technicians. Professionals involved in quality assurance of control systems, and those checking IQ validation documentation.
Community of Practice (COP)

  • This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).
Discounted member price: 700.00
You could save 12.5%
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

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

Approximate Course Duration: 2 Days (this is a self-paced course)

*NOTE* You will have 14 calendar days to access and complete this course from time of purchase

ISPE CEUs: 1.30 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 700.00 / € 574.00
Non Member Price: $ 800.00 / € 656.00