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PDA 529 Technical Report No. 54: Foundations of Quality Risk Management

Sep 21, 2023
Washington, DC

  • Education
  • The Americas
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Overview

This training course will provide an overview of the QRM process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.

This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.

Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

This training course is a prerequisite for all of the QRM Certificate Program tracks. For more information on PDA's QRM Certificate Program, please visit the "PDA Quality Risk Management Training Courses" page below.

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

PDA Quality Risk Management Training Courses
PDA Regulatory Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast and lunch will be provided.

Trainers

Virginia Andreotti-Jones
Virginia Andreotti-Jones
ValSource
Bio
Virginia Andreotti-Jones
ValSource

Virginia Andreotti-Jones is a consultant with ValSource, focused on providing innovative approaches to Quality Risk Management (QRM). Throughout her career, Virginia has played a crucial role in Quality Risk Management, Quality Event Investigations, and Quality Systems. Virginia is highly skilled with a well-rounded expertise in the Quality organization. In addition to QRM, her expertise specifically includes Quality Event Investigations, Quality Systems, Human Error Reduction (Human Performance), QC Equipment Qualification, Change Control, and Project Management. Virginia is also an active volunteer with PDA and currently serves on the Board of the Pacific Northwest Chapter of PDA. She holds a BS in Chemistry from Gonzaga University.
Tiffany A. Baker
Tiffany A. Baker
ValSource Inc.
Bio
Tiffany A. Baker
ValSource Inc.
Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the Quality Risk Management (QRM) process and explain the roles and responsibilities
    2. Describe when, where and how to apply risk management throughout the product lifecycle
    3. Plan and prepare for quality risk management activities
    4. Describe the formality associated with QRM tools
    5. Build a QRM program at your company
  • Who Should Attend

    This training course is intended for professionals who are new to quality risk management.

    Departments
    Quality Control, Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Validation

    Roles
    Analyst, Specialist, Operator/Technician, 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.

Renaissance Washington, DC Downtown

999 9th Street, NW
Washington, DC

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  • Accommodations
    The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA/FDA Joint Regulatory Conference!

    Rate: $331 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 18 August 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 15:00
    Check-Out: 12:00

    Reservations

    Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
    Online:     Click on the reservation link above

    Individual Cancellation

    All cancellations must be received by 23:59 local time 72-hours before arrival to avoid a penalty of one night room and tax. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. From museums to entertainment, this is the perfect base for exploring downtown DC. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi. Steps from shopping, dining, nightlife and sports, this hotel places the best of DC at your doorstep. Expect the extraordinary at Renaissance Washington, DC Downtown Hotel.

How to Get Here

By Air

The airports closest to the Renaissance Washington, DC Downtown hotel are Reagan National Airport (DCA, 4.6m/7.4km), Dulles International Airport (IAD, 27.8m/46.2km), and Baltimore-Washington International Airport (BWI, 32.1m/51.7km).

By Car

The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($35+/day) and valet parking ($61+/day) are available.

Other Options

The metro stations closest to the Renaissance Washington, DC Downtown hotel are Mount Vernon Square (yellow/green line, 0.4m/0.6km), Gallery Place (red/yellow/green, 0.3m/0.5km), and Metro Center (red/blue/orange/silver, 0.4m/0.6km). Please visit www.wmata.com for fare and schedule information.

Directions

Registration Fees

Early Registration
Registration Type Price By August 7, 2023
Member $899
Non-member $1,079
Gov't/Health Auth./Academic $699
Regular Registration
Registration Type Price After August 7, 2023
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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