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Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems Option 2

Nov 15, 2019
Bethesda, MD

  • Education
  • The Americas

Overview

This new training course will provide guidance and practical knowledge on how to manage quality risks throughout the manufacturing system lifecycle, as described in Technical Report TR 54-5: Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems. Through a combination of lecture, workshops, and case studies, attendees will learn and apply a variety of tools and techniques to ensure appropriate management of quality risks for facilities, utilities, equipment, and other manufacturing systems.

PREREQUISITES

Participants enrolling in this training course must have completed the following PDA training courses:

  • Foundations of Quality Risk Management or any offerings of the prior PDA training course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
  • Practical Application of Quality Risk Assessment Tools

Agenda

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

Trainers

Kelly Waldron
Kelly Waldron
Valsource LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain how Quality Risk Management is applied in the lifecycle of manufacturing systems
    2. Apply Quality Risk Management principles and tools during the Design phase of a Manufacturing System
    3. Apply Quality Risk Management principles and tools during the Qualification phase of a Manufacturing System
    4. Apply Quality Risk Management principles and tools during the Operation, Maintenance and Retirement phases of a Manufacturing System lifecycle
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are responsible for quality risk management in manufacturing.

    Departments
    Quality, Regulatory Affairs, Manufacturing, Validation, Engineering

    Roles
    Supervisor, Manager, Specialist, Analyst, Technician

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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 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 September 27, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839



Regular Registration
Registration Type Price After September 27, 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).

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 Oct 12, 2019, no fee will be charged. After Oct 12, 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 Oct 12, 2019, a full refund will be given minus a $200 fee. After Oct 12, 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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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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