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Parenteral Drug Association Connecting People, Science and Regulation ®

Single Use Systems for the Manufacturing of Parenteral Products

May 23 - May 24, 2017 |
May 24, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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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 SUSs 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 an SUS over a Multiple Use System (MUS) will help determine the most appropriate manufacturing strategy.

Who Should Attend

Pharmaceutical and Biopharmaceutical professionals in the following areas: procurement/purchasing, process development, senior management, regulatory, quality, and operations. It will be of significant value to end users, suppliers and regulatory personnel.

Upon completion of this course, you will be able to:

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

Standard

Member

On or Before April 7, 2017
$2,419

After April 7, 2017
$2,699

Nonmember

On or Before April 7, 2017
$2,915

After April 7, 2017
$3,239


Government/Health Authority/Academic

$1,619

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by April 24, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA 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 between 12:00 - 1:00 p.m. Snacks will be provided during breaks throughout the day.

Location

The course will be held at:

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

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Kimberly McIntire
Assistant Manager, Laboratory Operations
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

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 biosimilars.

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 the 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 Task Force for Single Use Systems.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #343 | ACPE #0116-0000-15-033-L04-P | 1.2 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.

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