ISPE CEUs: 1.5
Type: Classroom Training Course
The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.
Through interactive workshops participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification of pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.
Example “case studies” based on real-world projects will be used to provide participants with the opportunity to learn and practice how to develop user requirements, perform risk assessments and develop planning for commissioning and qualification based on the identification of the quality-critical aspects of facilities and equipment and utility systems and controls.
Immediately apply the course objectives using the complimentary copy of the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
At the end of the two-day workshop, attendees will:
This course will be of interest to those following the latest industry and regulatory initiatives, including application product and process understanding within qualification and the science- and risk-based approach with emphasis on commissioning and qualification of equipment and systems.
This training course is of particular interest to existing and future members of the ISPE Commissioning and Qualification Community of Practice (COP).