Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This two or 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.
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.
The Pharmaceutical Quality System (PQS), supported by ICH Q10, is the key foundation on which product realization depend. Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course. We will be using QMS and PQS terms interchangeably throughout this course to establish a holistic approach.
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.
This classroom course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.
Gary V. Zoccolante is the Technical Director of Plymouth Rock Water Consultants. He was formerly Pharmaceutical Technical Director for Evoqua Water Technologies. Zoccolante has over 40 years of experience in the design, operation and trouble-shooting of pharmaceutical water systems. He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation. Zoccolante, a member of ISPE since 1992 was a committee member of both the original and updated ISPE Baseline® Water and Steam Systems Guide.
This classroom course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes, and the regulatory requirements for their validation.
Andrew Collentro is Technical Director for Water Consulting Specialists, an engineering and consulting firm serving the pharmaceutical and biotechnology industries. He has more than 15 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems. Collentro is a member of the ISPE Training Faculty, and has taught courses for PDA and other industry organizations.
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.
At the completion of this course, attendees will understand how to identify areas of opportunity for applying the First Principle approach and how to present the results and benefits from such an approach. Many of the First Principle applications presented during the course will be made available to the attendees in macro driven Microsoft Excel files that can be used to review the examples and discuss with colleagues within their own organizations. Attendees are encouraged to bring a laptop with Microsoft Excel to gain maximum benefit from this course.
Bernard McGarvey Ph. D., retired as an engineering fellow at Eli Lilly and Company at the end of 2017. He has a B.E. and Ph.D. in Chemical Engineering from University College Dublin, Ireland. He spent 34 years working for Eli Lilly and Company at various locations in Ireland and the USA. He has held a variety of roles in process control and process engineering over this time, as well as time in corporate manufacturing. His main interest is in the application of First Principles thinking to improve engineering decision making and problem solving at Eli Lilly, covering both process development and manufacturing.