Commissioning and Qualification

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning....

The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive classroom 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....

The successful delivery of manufacturing facilities , (including small, large, new, expansion, or renovation type projects) regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. These facilities are required to meet all applicable GxP regulations, and to comply with all other relevant local and international governing codes, laws, and regulations. This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet documented process requirements, control risks within the manufacturing process, produce high-quality products and consistently operate to meet product and process requirements. Course topics....