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End-to-End Pharmaceutical Manufacturing Training

Jan 23 - Feb 03, 2017
Bethesda, Maryland

This unique training opportunity will provide hands-on experience through the entire manufacturing process. You will receive an introduction to all phases of the manufacturing process and have the chance operate the machinery through all phases (Upstream, Downstream, Analytical and Fill/Finish) of the process, from start to finish.

  • Education
Duration:  10 days
Time: 8:30 a.m. - 4:00 p.m.

Overview

This unique training opportunity will provide hands-on experience through the entire manufacturing process. You will receive an introduction to all phases of the manufacturing process and have the chance to operate the machinery through all phases (Upstream, Downstream, Analytical and Fill/Finish) of the process, from start to finish.

Upstream/Cell Culture

The session features hands-on instruction with various cell culture expression systems and introduces attendees to the techniques, methodologies, principles and applications of anchorage-dependent and suspension-adapted cell lines. Participants will track their own anchorage-dependent and suspension-adapted cell lines over a two day period. Attendees will also prepare, inoculate and harvest a cell culture bioreactor.

Downstream

The session will provide hands-on laboratory exercises and classroom instruction on recovery and purification strategies for biotechnology products, especially proteins. Participants will integrate theory with practice in areas such as cell separation, cell disruption, chromatography theory and systems, sample preparation, columns and packing, adsorptive chromatography and elution optimization.

Analytical

This industry-driven and application-focused laboratory session offers an avenue for training the next generation of biopharmaceutical analytical scientists. Laboratory experience utilizing NIST reference materials will provide an unparalleled simulation of industry-relevant characterization technologies. In addition to exposure and hands-on experience with state-of-the-art equipment, a series of lectures will be given to provide the requisite theory and industrial applicability of the methods.

Aseptic Filling

This session provides individuals with an understanding of the fundamental principles governing aseptic processing. The training will cover the systems associated with aseptic processing and how they work together to help ensure a sterile product. Participants will benefit from hands-on aseptically filling activities, equipment and instrument demonstrations and group projects designed to complement the content presented in the lectures.

Who Should Attend

This course is only open to U.S. FDA employees.

Agenda

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

    • Examine and test bench and pilot scale cell culture equipment
    • Apply recovery and purification strategies for biotechnology products
    • Demonstrate separation science in ensuring therapeutic protein quality by utilizing ultrahigh-performance liquid chromatography and capillary electrophoresis
    • Identify risks of product contamination using airflow visualization techniques
    • Examine the media fill operation to ensure appropriate observations and interventions

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway, Suite 150
Bethesda, Maryland

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Government/Health Authority/Academic

Member | Non-member

$4,995

All rates in U.S. dollars. REFUND FOR COURSES: If your written request is received by December 24, 2016, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELATION: PDA/UMD/NIST reserves the right to modify the material or instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA/UMD/NIST will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA/UMD/NIST at [email protected] or +1 (301) 656-5900.

Class Schedule

This course will 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 30 minutes before the start of the course to sign in. Be sure to bring your confirmation letter as proof of registration. PDA/UMD/NIST 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 first part of the training will take place at the University of Maryland’s Institute for Bioscience and Biotechnology Research/Shady Grove. The second part will be a hands-on fill/finish training at PDA’s Training and Research Institute (TRI) facility in Bethesda, MD.

Contact

For more information, please contact:

David Talmage
Director, Education
Parenteral Drug Association
Tel: +1 (301) 656-5900 x137
Email: [email protected]

Ben Woodard
Program Director
Biotechnology Research and Education Program, University of Maryland
Tel: +1 (301) 641-0621
Email: [email protected]

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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