Regulatory groups have responded by providing guidance documents such as ICH Q9: “Quality Risk Management” which encourages a level of risk appropriate to safety and efficacy and provides a toolbox of risk management methods. ICH Q8: “Pharmaceutical Development” encourages the use of scientific methods to mitigate risk through concepts such as Design Space, Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Verification.
Industry groups have responded with approaches such as the ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment provides an industry consensus framework to modify many of the cumbersome validation practices. The new standard strives to simplify the verification process by leveraging commissioning activities, with the engineering designers of equipment playing the key role in its qualification. With qualification activities consuming as much as 25% of the facility cost, a streamlined method for validation has the potential to result in large cost and time savings.
Areas Covered in the seminar:
Who will benefit:
Peter K. Watler, Ph.D, is currently the Chief Technical Officer for Hyde Engineering + Consulting (Hyde) where he is responsible for the strategic direction of Hyde and its expansion into new technical markets. Dr. Watler joined Hyde in 2007 as the Vice President of West Coast Operations. Dr. Watler brings 19 years of process development and GMP manufacturing experience in the biotechnology industry. His areas of expertise include process validation, fermentation, centrifugation, filtration, chromatography, process modeling, capacity planning, economic/COGs analysis, facility validation and manufacturing operations. He has prepared 3 IND and BLA submissions and participated in four FDA inspections and numerous GMP audits.
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