This course presents a systematic methodology for the project management of aseptic pharmaceutical manufacturing processes. This includes the associated equipment and the integration of the preliminary design, detailed design, construction, and validation phases of a project to minimize the challenges, and cost and schedule overruns typically associated with implementing these complex processes. The content includes selection of the project team, defining the process requirements the equipment is required to meet, preparation of the equipment user requirements specifications, preparation of the equipment layout, preparation of the equipment budget, preparation of the project schedule, managing the construction of the equipment, managing the testing of the equipment, and installation of the equipment and site acceptance testing. Also addressed will be selection of and dealing with equipment vendors, planning for validation success, and regulatory acceptance.An aseptic manufacturing process case study is used as a basis for the lecture series. The process will be followed from the preparation of the raw data used to determine the process requirements through to final installation and acceptance of the aseptic processing equipment on site.
Schaefer School of Engineering & Science
Department:
Mechanical Engineering
Austin McDonald is a Senior Engineer and Partner at GL Engineering a provider of specialized engineering services to the pharmaceutical industry, supporting clients with the design, procurement, testing and facility integration of aseptic filling equipment and isolator systems. Austin has extensive experience implementing processes in Europe and the United States, specializing in sterilization systems, sterile component handling, filling of vials & syringes, lyophilization, lyophilizer loading systems, automated inspection systems and the handling of complex materials including, cytotoxic substances, carcinogenic substances, biological hazards & radioactive pharmaceuticals. Prior to co-founding GL Engineering, he was Director of Barrier Technology at Kvaerner Process, Bridgewater NJ, and a Director at the Tanshire Group, Elstead, Surrey, UK (now Bovis Lend Lease). He has spoken at numerous conferences on sterile processing and isolation technology and is a member of ISPE.
Experience & Service
Professional Service
Austin McDonald is a Senior Engineer and Partner at GL Engineering a provider of specialized engineering services to the pharmaceutical industry, supporting clients with the design, procurement, testing and facility integration of aseptic filling equipment and isolator systems.
Experience
Austinhas extensive experience implementing processes in Europe and the United States, specializing in sterilization systems, sterile component handling, filling of vials & syringes, lyophilization, lyophilizer loading systems, automated inspection systems and the handling of complex materials including, cytotoxic substances, carcinogenic substances, biological hazards & radioactive pharmaceuticals.
Prior to co-founding GL Engineering, he was Director of Barrier Technology at Kvaerner Process, Bridgewater NJ, and a Director at the Tanshire Group, Elstead, Surrey, UK (now Bovis Lend Lease).
Achievements & Professional Societies
Professional Societies
He has spoken at numerous conferences on sterile processing and isolation technology and is a member of ISPE.
