Join us after the 2018 ISPE Annual Meeting & Expo for an in-depth education experience on the following topics:
This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication. Additional content includes elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes and establishment of scientific rationales acceptable to regulatory inspectors. For mature cleaning validation programs, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation program and documentation will be essential takeaways.
Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. She began work with Quality Executive Partners, a boutique consultancy to make a difference in pharmaceutical consulting in 2013.
This interactive course provides more than the usual project basics. It develops the concept of project lifecycle from initiation through delivery of business benefits, along with tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of "good practice" project management. Trends in regulatory compliance, environmental, health and safety legislations, project delivery methodologies, and product speed-to-market expectations all impact how pharmaceutical facility projects are managed. Each course module introduces key project management concepts and tools as well as methodologies that specifically support successful project delivery.
Dr. Trish Melton is Managing Director of MIME Solutions Ltd., an engineering and management consultancy providing project, programme & risk management, business change & improvement management, regulatory, validation and GMP consulting for pharmaceutical, chemical, and healthcare clients. She has previously worked for Eli Lilly and GSK, amongst others. Trish has worked as a project manager and project management consultant on engineering and non-engineering projects worldwide, predominantly within the global pharmaceutical & biopharmaceutical industry. She is a chartered Chemical Engineer and a Fellow of the Institution of Chemical Engineers (IChemE), where she was the founder Chair of the IChemE Project Management Subject Group and authored a series of IChemE publications, the Project Management Toolkit.
This interactive course will provide tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program. Through interactive workshops participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8(R2), Q9, and Q10) to the documented verification of pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.
Mr. Michael Westerman has over 15 years of experience providing project management, equipment, software, process validation, and quality / operational management in regulated industries. His Industry experience is backed up with a strong educational background in biology, technical quality engineering and business that uniquely positions him to assist his clients and colleagues for find innovative solutions for their CQV projects and challenges.
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.
Bruce Davis is a professional engineer, and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and reducing Human Error. He is an Associate to NSF-DBA, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities.