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

ISPE CEUs*: 1.5 (including Webinar)
Type: Classroom Training Course

Upcoming Dates and Locations

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 an associated automation platform. 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 to implement 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.

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

Webinar Learning Objectives

• 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

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 Introduction to Commissioning and Qualification training course or those who have basic knowledge and understanding of the Commissioning and Qualification Baseline® Guide.