Basic Principles of Commissioning and Qualification
Applying the Commissioning and Qualification Baseline® Guide Principles

ISPE CEUs*: 1.3
Type: Classroom Training Course

Upcoming Dates and Locations:

Date

Location

Country

Instructor(s)
25-26 Feb 2008 ISPE Conference on Manufacturing Excellence
Tampa, FL		 United States Les Huffman
21-22 May 2008 Brussels Training Series
Brussels		 Belgium Robert Adamson

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.

Complimentary copy of the Commissioning and Qualification Baseline® Guide provided.

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

Who Should Attend

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

Communities of Practice (COPs)
Commissioning and Qualification

Related Technical Documents
Commissioning and Qualification Baseline Guide

Important Course Notes

  • Includes On-line Essentials, a pre-recorded, Web-based session providing a review of basics prior to the classroom course
  • Course contains information related to the Certified Pharmaceutical Industry ProfessionalSM ( CPIPSM ) technical knowledge competency element of Facilities and Equipment - www.ISPE-PCC.org