Basic Principles of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline® Guide Principles (T15)

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Level: Fundamental
Type: Classroom Training Course
ISPE CEUs: 1.3

Date Location Country Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.

Description

With extensive processes to ensure compliance, operational safety and efficiency, commissioning and qualification procedures play a critical role in equipment and facility maintenance. A well-conceived and correctly executed commissioning and qualification plan can save time and money on validation. ISPE's Commissioning and Qualification Baseline® Guide was published to give professionals advice and guidance for developing and carrying out an effective commissioning and qualification plan.

The Baseline Guide will form the basis for this course, covering topics such as philosophy/concepts, impact assessment, good engineering practices (GEPs), commissioning versus qualification, and methods of integrating commissioning and validation activities. Participants will discuss the typical components of qualification protocols: installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), enhanced design review (EDR), and failure mode analysis.

In addition to classroom lectures, participants will take part in several interactive exercises that allow application of learned content and familiarity with the structure and content of the guide.

Course Modules

  • Philosophy/Key Concepts
  • FDA Feedback
  • Requirements Definition
  • Good Engineering Practice (GEP)
  • Impact Assessment
  • Impact Assessment Workshop
  • Enhanced Design Review (EDR)
  • Component Criticality Assessment Workshop
  • Commissioning
  • Qualification Practices
  • Related Topics
  • Impact Assessment Worksheets
  • Component Criticality Assessment Worksheets
  • FDA C&Q Guide Comments
  • C&Q Course Abbreviations and Acronyms

Commissioning and Qualification Cover Image

Participants will receive a complimentary copy of the Commissioning and Qualification Baseline® Guide.

Take Back to Your Job

  • The ability to describe Commissioning and Qualification Baseline® Guide content and concepts, and discuss the difference between commissioning and qualification and when to apply each as well as GEP fundamentals
  • How to develop, manage, and execute commissioning and validation master plans
  • Understand critical activities related to a successfully integrated commissioning and qualification project including change control, training, turnover packages, and standard operating procedures 
  • How to evaluate the impact of a system on product quality, identify critical components within that system, and integrate critical activities including failure mode analysis

Attendance Suggested For

  • Equipment engineers, quality assurance specialists, and management personnel who require a fundamental and thorough understanding of the commissioning and qualification process. Also those with a fundamental knowledge but wish to sharpen their skills and learn how to use the Commissioning and Qualification Baseline® Guide as a resource

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Commissioning and Qualification (COP).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses.  CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.  Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials.  Statements of credit will be available for download in your ISPE account within four weeks of the completion of training.  Instruction for download will be sent when the CEUs are available.  One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 21 February 2014

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