Quality by Design (QbD) is a concept that has become mainstream in the pharmaceutical manufacturing space in recent years. QbD is a science- and risk-based approach to quality that identifies, measures and defines the critical processes that impact quality and provides a pathway to introduce quality and risk management into the design process. This webinar will discuss the Quality by Design process as it relates to logistics and evaluate its benefits.
The QbD concept within logistics cannot be implemented without an in-depth understanding of the equipment and processes by which critical pharmaceutical commodities are packaged and shipped. The key to QbD implementation is the ability to measure and preemptively control variation in real time using modern tools such as GPS-enabled data loggers. In addition to providing the ability to measure and understand the in-transit variation that exists, GPS data loggers collect critical data to help forecast, analyze and design process controls to eliminate the deleterious effects of the observed variation, using three basic activities:
- Evaluate the actual performance of the equipment and in-transit processes
- Compare the actual performance of the equipment and in-transit processes with goals
- Act on any discrepancies observed during the in-transit process
Automating the risk management process through effective use of QbD using real-time informatics is a critical consideration when contemplating support of any commercial pharmaceutical product. Informatics that can capture, interpret and provide automated alerts and pre-defined escalation protocols based on the nature of the data captured for hundreds if not thousands of concurrent shipments will be critical in the effective launch of next generation therapies. QbD processes provide the foundation enabling such an approach to be effective.
Mark W. Sawicki, Ph.D., Chief Commercial Officer, Cryoport
Mark Sawicki is chief commercial officer of Cryoport, a provider of end-to-end cold chain logistics solutions to the life sciences industry. Sawicki, who has more than 15 years’ experience in the pharmaceutical and biotechnology industries, holds a bachelor’s in biochemistry from the State University of New York at Buffalo and a Ph.D. in biochemistry from the State University of New York at Buffalo, School of Medicine and Biomedical Sciences. He also received graduate training at the Hauptman Woodard Medical Research Institute. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology
Who Should Attend?
Senior professionals from Pharmaceutical, Biotechnology & Life Sciences companies, Clinical & Health Care organizations, and CMOs
Relevant areas include:
- Clinical Operations
- Laboratory Management
- Materials Management
- Research & Development
- Supply Chain / Logistics / Shipping / Transportation
- Procurement & Purchasing
- Quality Assurance / Quality Control
- Program Management
- Product Management
Cryoport is the life sciences industry’s most trusted global provider of cold chain logistics solutions for temperature-sensitive life sciences commodities, serving the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as regenerative medicine, including immunotherapies, stem cells and CAR-T cells. Cryoport’s solutions are used by points-of-care, CROs, central laboratories, pharmaceutical companies, manufacturers, university researchers, et al; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproduction. Cryoport’s proprietary Cryoport Express® shippers, Cryoportal™ logistics management system, leading-edge SmartPak II™ condition monitoring system and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end cold chain logistics partner that the industry trusts.