Join us as we take a deep dive into critical areas of pharmaceutical manufacturing.
This classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing 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 in the regulated pharmaceutical environment. Trends in regulatory compliance, environmental, health and safety legislation, project delivery methodologies and product speed to market expectations all impact how pharmaceutical facility projects are managed. Each course module introduces key generic project management concepts and tools as well as methodologies which specifically support successful project delivery within the regulated pharmaceutical industry. This course is structured around a typical facility project lifecycle of Project Initiation, Delivery Planning, Design Planning and Delivery, Procurement, Construction, Commissioning and Qualification and Project Close-Out & Review and uses case study examples throughout to illustrate key points.
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.
The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. 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.
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. (FR Brussels 2012)
This course will trace the evolution of Process Validation from it’s infancy in the 1980’s to its current state of maturity. The level of evolution is evidenced with so many relevant guidance documents: ICH Q8, Q9, Q10 and Q11, the upcoming Q12, the 2011 US FDA guideline on Process Validation, EMA’s Process Validation documentation (general PV guideline, Annex 15, and biotech products). Now more than ever, there is a need to understand that process validation should be considered a science- and risk-based, life cycle activity rather than a one-time event of manufacture of three commercial scale batches. Companies should demonstrate that processes in the commercial phase of the lifecycle are maintained in a state of control using these techniques.
Tara Scherder has over 30 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, master black belt, and educator. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for small and large molecule platforms. Tara’s formal education includes a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University. Her current passion as partner at SynoloStats is the implementation of statistical methods for lifecycle process validation, with a keen focus on business context and value.
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.