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Level: Advanced - Application
Type: Classroom Training Course
ISPE CEUs: 1.5
Includes Webinar

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 utilities, 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.

Course Modules

• Formation of the Project Team
• Development of User Requirements
• Performing System Impact Assessment
• Developing the Validation Master Plan
• Developing the Commissioning Plan
• Development of the Project Test Plan
• Identification of Deliverables
• Performing Component Criticality Assessments
• Performance of Enhanced Design Review
• Development of the Commissioning Protocol
• Development of IQ and OQ Protocols
• Development of the PQ Protocol
• Background Info

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

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

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar two weeks prior to the start of the training event.

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

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.

Community of Practice (COP)

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

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment and Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

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