Join us after the Quality Manufacturing Conference as we take a deeper dive into critical areas of Quality Manufacturing.
Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.
Robert A. Warn
Commissioning Agents Inc
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 highly interactive course recommends good practices based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP® 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems and the full system lifecycle from concept to retirement. You will learn how appropriate QRM and specification and verification activities should be an integral part of the normal system lifecycle. The course also promotes leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.
James W. John
Sr. Project Manager
JWJ Consulting LLC
James W. (Jim) John, PMP, is a Senior Project Manager with ProPharma Group and has worked with clients in the areas of pharmaceutical project management, validation, and Part 11 remediation in the manufacturing and laboratory environments for the past fifteen years. John began his career working in plant operations and engineering in the chemical industry with BASF followed by several years working in the Manufacturing IT Group at Nabisco. He has served as a featured speaker at conferences in the U.S., Canada, Europe, and Japan. John has been a member of ISPE and the ISPE Midwest Chapter for 22 years. In support of ISPE, John has served on guideline development committees for ISPE (including GAMP®) and PDA, and has had papers published by ISA, Pharmaceutical Online, and ISPE's Pharmaceutical Engineering magazine.
The 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. Using a Process and Production Video Simulation for Unit Ops, including Mixing, Blending, Drying, Sizing, Tableting, Encapsulating and Coating provides participants with a visual demonstration of current manufacturing and engineering practices. The simulation will vividly present real-time experiences for identifying and analyzing the problem identify the root cause and present solutions. A case study for production related issues and concerns will also be utilized.
Jack C. Chu, PE
Senior Consultant- Special Products
Commissioning Agents, Merck & Co., Inc (Retired)
Jack Chu is a licensed Professional Engineer. He has designed and implemented many outstanding projects worldwide since 1985. Jack also successfully leads number of professional task forces as SME (subject matter expert) for many complicated engineering problems and business/technical/operational challenged legal cases. 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.
This interactive course uses group exercises to provide examples of how products and processes can be developed, using QbD with special emphasis on the considerations for implementing these processes in manufacturing. Topics include: understanding the principles of a science-and-risk-based approach, product and process understanding and patient requirements; using tools and techniques provided to understand QRM; implications of relevant ICH, EMA, ASTM E2500, and USFDA Guidelines; QRM tools (FMEA, risk ranking); applying FMEA to Control Strategy selection; and relationship between PQS and GMP and how they link to Control Strategy; considerations when implementing a control strategy derived from enhanced, QbD approaches; and opportunities for continual improvement arising from application of statistical techniques.
Director of Quality Assurance
Stephen Tyler is a Director of 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. The code for how to pull in an dynamically from iMIS can be found on the style guide towards the bottom.
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. Guidance on the transition of an organization’s approach to C&Q to one that incorporates a science and risk-based approach will be discussed including 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 J. Wisniewski
Principal Compliance Consultant
Commissioning Agents, Inc
Steven Wisniewski is Principal Consultant for CAI Consulting, a highly respected provider of consulting and technical services for biotech and pharmaceutical manufacturers worldwide. He has more than 35 years’ experience in the pharmaceutical, biotech, and device industries. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities and upgrades. He holds a BSME from Rensselaer Polytechnic Institute, is an active Member of PDA and has participated on a Technical Report draft team, and an active Member of ISPE. He served on the ISPE board of directors beginning in 1982, and was chairman of the board in 1991.