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:
Government / Health Authority / Academic
|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.
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.
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
For more information, please contact:
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137
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