Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This classroom training course in biopharmaceutical manufacturing facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.
Robert Warn is a Senior project manager and Principal Engineer at Commissioning Agents Inc., with over 14 years in the biotechnology industry. He has extensive project management, process engineering, commissioning, qualification and process validation experience on biotechnology manufacturing systems and equipment. His expertise are focused on process tech-transfer and manufacturing equipment implementation. As well, Robert has consulted on implementing PPQ and C&Q programs for his clients. Robert has a mechanical engineering background and is a current member of the ASME Bioprocessing Equipment (BPE) Standards Committee.
This classroom course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.
Jack Chu is a licensed Professional Engineer. He has designed and implemented many significant projects worldwide since 1985. Jack also successfully led professional teams as expert witness for many complicated legal cases relating to engineering, technology, and operational issues. Mr. Chu is a leading expert in OSD (Oral Solid Dose Form) process development, quality assurance, facility & equipment system design and implementation, including manufacturing and technical operations. Jack is one of the strong advocates for “PAT Implementation”, “Single-use Technology Application” and “Continuous Manufacturing Process” for Pharmaceutical and Biological Manufactures. He brings many successful engineering solutions and recommendations to pharmaceutical industry and academia societies.
This course shows how appropriate quality risk management and specification and verification activities should be an integral part of the normal system life cycle. Many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The course promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.
Through group exercises, this classroom course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.
Stephen Tyler is a Director of Technical Operations for Operations’ Quality Assurance at AbbVie, a biopharmaceutical company, in North Chicago, Illinois, USA. Stephen holds B.S. degrees in Applied Biology and Chemical Engineering and a M.S. in Microbiology. Stephen joined AbbVie (Abbott) in 1984 and the Quality Assurance organization in 2008. He is a former international board member for ISPE, former co-chair of the ISPE PQLI technical committee and current chair for the ISPE PQLI Steering Committee. Stephen was the recipient of the 2013 ISPE Richard B. Purdy Distinguished Achievement Award that recognizes an ISPE member who has made significant, long-term contributions to the society.
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.
Steven Wisniewski is Principal Consultant for CAI Consulting, a highly respected provider of consulting and technical services for biotech and pharmaceutical manufacturers worldwide. CAI Consulting focuses on the manufacturing lifecycle process, with services including commissioning, validation, technology transfer, owner Project Management, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 35 years’ experience in the pharmaceutical, biotech, and device industries.