This course will provide students with critical concepts to consider when implementing a single use system (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 course will discuss single use systems that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products.

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.

Upon completion of this courses you will be able to:

• Describe the necessary considerations and steps to accomplish a successful evaluation and implementation of a single use strategy
• Define process operating parameters and requirements necessary when examining single use solutions
• Determine potential impact of a SUS on product quality
• Compare and contrast single use technology and multi-use technology
• Assess risk by considering the potential for the single use system to interact with product or process fluids
• Outline supplier control strategies to ensure successful single use system implementation
• List minimum requirements, impact of different sterilization methods on materials of construction, and validity of testing approach

Robert Repetto, Senior Director, External Affairs,Pfizer, Inc.

Robert’s current position is a Technical Advocacy function focused on industry and regulatory trends that enable the BioTherapeutics and Vaccine portfolio. Robert also leads Pfizer’s contract manufacturing strategy for Biosimilar’s.

Technical Advocacy Topics of interests include: Single Use Systems, QbD, Risk Management, Biosimilars, and Innovative new therapies.

Prior to this position Robert was Director of Technology and Innovation for Wyeth Biotech, where he was responsible for development of strategies focused on new technologies, innovation, risk management, process technology, and real time process monitoring. Robert has over 20 years of process development, manufacturing and clinical production experience with mammalian, insect and bacterial expression systems. He holds a B.E. in Chemical Engineering from Manhattan College, M.S. in Bioengineering from Polytechnic University of New York, and a MBA from Iona College.

Robert is currently Chairman of the PDA’s Global Taskforce for Single Use Systems.

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before July 03, 2013	$2,245	$2,515	$1,500	$1,600
Price After July 03, 2013	$2,495	$2,795	$1,500	$1,600

All rates in US dollars.

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #343 | ACPE #0116-0000-12-343-L04-P | 1.2 CEUs
Type of Activity: Knowledge, Application