Single-Use Systems for Manufacturing of Parenteral Products

Location: PDA Training and Research Institute, Bethesda, Maryland
Date: October 22-23, 2014
Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

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 September 05, 2014  $2,350 $2,595 $1,500 $1,600
Price After September 05, 2014 $2,595 $2,895 $1,500 $1,600

All rates in US dollars.

Class Schedule

All lab courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.

Location

The course will be held at the PDA Training and Research Institute:

PDA Training and Research Institute
4350 East West Highway, Suite 150
Bethesda, MD 20814

Contact

For more information, please contact:

James Wamsley
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137

Email: wamsley@pda.org

ACPE 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

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