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The Impact of CGMPs on Biomanufacturing Facility Design and Operation - Option 2

Sep 11, 2019
Bethesda, MD

  • Education
  • The Americas

Overview

The global growth of biologic platforms in the manufacturing of human therapeutic products has placed an increased emphasis on understanding the impact of current Good Manufacturing Practice on facility design and operation. New product and technology platforms are pushing the boundaries of our comfort zone in understanding the impact of the GMPs on facility attributes and risk mitigation.

This training course will help you identify the current global landscape of GMPs and focus on the basis of GMP implementation, risk and impact assessment, product-process-facility attributes, and some general considerations in global GMP guidelines. During this training course, you will use case study examples and interactive exercises to interpret and apply the GMPs on biomanufacturing facility design and operation.

Agenda

  • Training courses run from 8:30 to 16:00 each day. An agenda will be provided on the first day of the training course.

Trainers

Jeff Odum
Jeff Odum
NNE

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify key areas of GMP definition that impact facility design, equipment design, operational approach, and facility logistics and compliance
    2. Identify the key areas of risk associated in biomanufacturing related to facility design and operational approach
    3. Apply current regulatory trends and fundamentals to develop concepts for biomanufacturing facility design that meet global regulatory guidelines
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in drug manufacturing.

    Departments
    Engineering, Quality Assurance, Manufacturing, Project Management

    Roles
    Engineers, Facility Managers, Managers, Project Managers

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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 July 26, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839





Regular Registration
Registration Type Price By July 26, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839





* 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).

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SUBSTITUTION: If a substitution request is sent by Aug 10, 2019, no fee will be charged. After Aug 10, 2019, 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 Aug 10, 2019, a full refund will be given minus a $200 fee. After Aug 10, 2019, 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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