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Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Aug 03, 2020
Bethesda, MD

  • Education
  • The Americas

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Overview

This training course is designed to provide and evaluate recommendations specific to the operation of Blow-Fill-Seal (BFS) technology for the manufacture of sterile pharmaceuticals, e.g., injectable, ophthalmic, parenteral, and inhalation drugs and medical devices. Supplemental information to assist users with interpretation of international standards and regulatory guidance regarding BFS operations will also be provided.

Basic knowledge of aseptic fill/finish packaging, cGMP and regulatory requirements is desired.

For more options and/or related training courses, please visit the page(s) below.

PDA Packaging Training Course Series

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Andrew W. Goll
Andrew W. Goll
Weiler Engineering, Inc.
Martin   Haerer
Martin Haerer
Rommelag CMO
Tim Kram
Tim Kram
Rommelag USA, Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the recommended requirements necessary to utilize blow-fill-seal (BFS) fill/finish technology
    2. Assess if BFS technology can be applied to new or existing pharma products
    3. Describe the basic principles of BFS: cleanroom facility design, environmental monitoring, and aseptic processing
    4. Explain the process of evaluating product contact materials, extractable profiles and leachable risk
    5. Evaluate the aseptic risk of BFS in comparison to other advanced aseptic fill/finish operations: isolators and closed RABS systems
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in sterile drug manufacturing using blow-fill-seal processes.

    Departments
    Quality Assurance, Quality Control, Manufacturing, Packaging, Development, Technical Support

    Roles
    Analyst, Specialist, Engineer, Scientist, Supervisor, Manager

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By June 19, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979


Regular Registration
Registration Type Price After June 19, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979


* 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 by Jul 04, 2020, no fee will be charged. After Jul 04, 2020, 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 by Jul 04, 2020, a full refund will be given minus a $200 fee. After Jul 04, 2020, 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

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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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