that this training course will take place in person. Please read our COVID-19 Facility Access Rules
before registering for this training course.
Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a balanced viewpoint with consideration from engineering, regulatory, quality project management and accounting. Balancing risks and rewards of a Single Use System (SUS) over a Multiple Use System (MUS) will help determine the most appropriate manufacturing strategy.
Based on PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing, this training course will provide attendees with critical concepts to consider when implementing an SUS strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized, small molecules and for bioprocesses that produce large-molecule, biopharmaceutical products.
The training course will discuss SUSs that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products.