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PDA 547 Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

May 20, 2022
Bethesda, MD

  • Education
  • The Americas
Cancelled

Overview

This training course will provide guidance and practical knowledge on how to manage quality risks throughout the manufacturing system lifecycle, as described in PDA Technical Report No. 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.

Participants will also receive a free copy of PDA Technical Report No. 54-5: Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems.

PREREQUISITES

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

  • PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management or any offerings of the prior PDA training course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
  • PDA 531/531.1 Technical Report No. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools

Additionally, participants should have read PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

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

PDA Quality Risk Management Training Courses

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Agenda

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

Trainers

Kelly Waldron
Kelly Waldron
ValSource Inc.
Bio
Kelly Waldron
ValSource Inc.

Dr. Kelly Waldron is currently the Business Unit Manager (Quality and Manufacturing Science) and a Senior Consultant with ValSource, as well as a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Dr. Waldron’s expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a PhD in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA and can be reached at [email protected].

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

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

    Departments
    Quality Control, Quality Systems, Engineering, Manufacturing, Quality Assurance Operations, Regulatory Affairs, Validation

    Roles
    Analyst, Specialist, Supervisor, Manager

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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 following airports are near the training course location: 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 take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

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.

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Registration Fees

Early Registration
Registration Type Price By April 5, 2022
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699


Regular Registration
Registration Type Price After April 5, 2022
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699


* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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