|This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.|
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.
Participants will receive a complimentary copy of the Commissioning and Qualification Baseline® Guide.
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.
This training course is of particular interest to existing and future members of the ISPE Commissioning and Qualification (COP).
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.
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.