Application of Commissioning and Qualification
Applying the Commissioning and Qualification Baseline® Guide Principles (Includes Webinar)

Milan, 6-7 October 2008

Advanced Level
ISPE CEUs*: 1.5
Type: Classroom Training Course and Webinar

Instructor: Bob Adamson, Foster Wheeler Energy Ltd. (UK)

Description
Through interactive workshops, this course will apply the principles of the Commissioning and Qualification Baseline® Guide for a project consisting of process equipment components, classified area, critical utilites, and associated process control. Activities begin with formation of a project team; development of critical requirements for projects based on current good manufacturing practices (cGMPs) and the basis of design; performance of an impact assessment including system impact and component criticality assessments; and performance of enhanced design review. Participants will then develop an outline for the contents of a commissioning plan and validation master plan; develop a test plan toimplement the integration of commissioning and qualification; and develop an outline for the contents of the Commissioning and Qualification Baseline® Guide including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols for one system.

Take Back to Your Job
  • Assemble an effective project team including assignment of roles, responsibilities, and authority
  • Examine the critical requirements for a project based on cGMPs, basis-of-design, and design documents
  • Perform impact assessments including system impact assessment and component criticality assessment based on provided design documents
  • Execute an effective enhanced design review to verify that the critical requirements are incorporated into design
  • Formulate an integrated commissioning and qualification strategy using test plans
  • Develop a content outline of the commissioning and validation master plans
  • Construct test plans for each system to specify how commissioning and qualification will be implemented and use the plans in the development of qualification protocols
  • Prepare an outline of the qualification protocol contents for provided systems and equipment based on actual design

Attendance Suggested For
  • Individuals who have previously attended the Basic Principles of Commissioning and Qualification training course or those who have basic knowledge and understanding of the Commissioning and Qualification Baseline® Guide
  • This Training Course is of particular interest to existing and future members of the ISPE Commissioning and Qualification Community of Practice (COP)

Important Course Notes
  • Receive the training you need to improve your role as a GMP auditor
  • Define project team roles and responsibilities
  • Describe user requirements, system impact assessments, validation master plan issues, the commissioning plan, and project test plan components• Discuss component criticality assessments, project deliverables, enhanced design reviews, and commissioning and validation protocols