Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Join us as we take a deep dive into critical areas of pharmaceutical manufacturing at the ISPE Bethesda Training Facility located at 6110 Executive Blvd, Suite 600, North Bethesda, MD 20852.
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 and Qualification to one that incorporates a science and risk-based approach will be discussed.
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. 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. Wisniewski served four years as chairman of the ISPE Community of Practice for Commissioning and Qualification, and was on the ISPE task team that developed the ASTM E2500 Verification Standard.
This Classroom training course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.
This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scalable and efficient system lifecycle, Quality Risk Management, GAMP® categories, the role of the supplier, and the selection of appropriate specification and verification activities.
Winnie Cappucci retired from the position of Associate Director Product Supply IT Systems Compliance, North America for Bayer HealthCare. She has worked in the pharmaceutical industry for 43 years and in global roles for the last 19 years. Ms. Cappucci has worked as a business process owner, an IT professional and lastly as a quality and compliance specialist in a highly regulated environment. In her last role Ms. Cappucci was responsible for developing and implementing Bayer’s global standards for computerized systems compliance. She is a past member of the ISPE International Board of Directors, Chair of the GAMP Council, member of the GAMP America Steering Committee and the GAMP Editorial Board.
Technology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods between development and manufacturing sites and contract manufacturing organizations (CMOs) has become increasingly important. This classroom course identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and regulators to use when conducting and evaluating technology transfer activities.
Jefferey Jones, Executive Director of Quality at Humacyte, Inc., has over 20 years of experience with development-stage and commercial biopharmaceutical process technology transfer. In his current role, Jefferey oversees Quality aspects of facility, process, and instrumentation design and scale up for a novel biologic process manufacturing bioengineered blood vessels. Prior to his work at Humacyte, Jefferey was responsible for Manufacturing Operations, Quality Assurance/Control, and Validation at Emergent Biodefense in Lansing, Michigan. Jefferey previously held positions overseeing Quality Assurance, Quality Control, and Product Development activities at MedImmune, Inc. and Human Genome Sciences. Jefferey earned a Bachelor of Science degree in Biology from Virginia Polytechnic Institute and State University and a Master of Science degree in Biotechnology from The Johns Hopkins University.
This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
Participants will review global cGMP regulations, including an update of ISO14644-1 & 2 reflecting 2015 changes, as well as common interpretations of those regulations and how they may apply to their facilities. The class will explore critical issues at each stage of the product lifecycle, from R&D to Manufacturing, such as: controlling cross-contamination between products, determining the correct classification of spaces, proper control of storage temperature and humidity, setting acceptance criteria for HVAC systems and using risk assessment to set environmental criteria. Workshops that include templates will be provided to help participants immediately apply what they have learned.
Norman Goldschmidt is President and Sr. Principal at Genesis Engineers. He has over 30 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry. Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing. Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) delegate, Adjunct Professor at the New Jersey Institute of Technology, Lead Author of the ISPE Good Practice Guide for HVAC as well as author, contributor and instructor for ISPE, ASHRAE, David Begg Associates and others.
This classroom course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, air filtration, HVAC design considerations, and a brief introduction to barrier isolation technology.
Mark von Stwolinski is the Vice President of Architectural Services at Clark Richardson & Biskup (CRB) Consulting Engineers. He has over 22 years of experience in the design and construction of biopharmaceutical facilities worldwide. His experience with ISPE guidance documents includes: Steering Committee member and contributing author for five ISPE Guides, Chair and contributing author for the new ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities, issued in 2013, ISPE Course Instructor for the 2-day Sterile Product Manufacturing Training Course in North America, Member of the ISPE Guidance Document Executive Committee (GDEC) and Lead Process Architect for CRB.
Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: am I even focusing on the right questions? Course participants will focus on the practical application of the lifecycle approach to all stages of process validation to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry.
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.