Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
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 biopharmaceutical manufacturing 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 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 course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography.
Rusty Morrison is an experienced pharmaceutical professional with over 30 consecutive years of experience at all levels in technology transfer, CMC project management, process validation, commissioning, qualification, validation, engineering, and manufacturing. Significant biopharmaceutical experience includes managing a bulk drug substance site-to-site tech transfer; managing early-stage RNA interference CMC activities for multiple products in the development pipeline; multiple assignments managing teams providing risk-based validation, commissioning, and engineering services for mammalian cell culture facilities; and serving as Director of Facilities & Engineering for a startup vaccine manufacturer. Other relevant experience includes leadership of a team responsible for all process validation protocols for the start of commercial operations at one of the largest mammalian cell culture facilities in the U.S.; including protocol generation, execution, deviation resolution, and report preparation.
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
Dr. Perez retired at the end of 2015 from the position of Director, Information Governance and Management for Novartis Pharmaceuticals. His responsibilities at Novartis included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. He served on several global Novartis teams dealing with computer systems compliance issues and authored many of the firm's global GxP compliance policies. During his 32-year tenure at Novartis, he developed a broad range of experience. He was part of the core team that led the development of GAMP® 5, published in 2008. In addition, he initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and he led the team that developed the second edition of this guide that was published in 2017. He was the lead author of the 2014 GAMP® GPG “A Risk-Based Approach to Regulated Mobile Apps,” and was part of the core author team for the 2017 “ISPE/GAMP Guide to Record and Data Integrity.”
This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System. It will provide you with practical application of quality risk management tools in preparation and planning for validation of your manufacturing control strategy. It will deliver statistical approaches and tools which can be used to strengthen and justify your decision-making rationale for defendable process design and process performance.
Shawn Gould is Director of Compliance with Johnson & Johnson’s Regulatory Compliance group. He currently holds responsibilities in the Pharma Segment overseeing compliance issues regarding large molecule products as well as serving on Proactive Compliance and PV Lifecycle Implementation teams. Shawn also served in the US Food and Drug Administration’s Office of Compliance where he worked on the pre-approval process for new and generic drugs with special emphasis on applications involving QbD and PAT concepts. He also served on FDA working groups relating to Quality Systems, the PAI process, Strategic Planning, and Lean Operations within the agency.
Katherine Giacoletti, a partner at SynoloStats LLC, has worked as a statistician in the pharmaceutical industry for over 18 years and has expertise across the product lifecycle, from non-clinical product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. Katherine is highly skilled in a wide range of statistical methodologies, and has the expertise to choose the best methodology to meet both scientific and business demands. She has experience applying modern statistics to biologics (including biosimilars) development and manufacturing - with expertise in complex, modern statistical tools, but always choosing the simplest statistical approach that protects the patient, based on the context of the application. Katherine lives in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.
This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Jack Chu has more than (30) years business experiences in Bio-pharm and Life Sciences Industries. After about (25) year services at Merck, Jack joined CAI (Commissioning Agents, Inc.) as Senior Consultant in 2017. He is a licensed Professional Engineer who 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.