|This course is not currently scheduled, but may be offered at your company site. 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 one week 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).
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.