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

Apr 06, 2023
New Orleans, LA

  • Education
  • The Americas
Cancelled

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

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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

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.

Hyatt Regency New Orleans

601 Loyola Avenue
New Orleans, LA

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  • Accommodations

    Rate: $255 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 03 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 16:00
    Check-Out: 11:00

    Reservations

    Online: Click on the reservation link above
    Phone: +1 (504) 561-1234, make sure to give the PDA Group Code, G-PDAA, to receive the discounted conference rate

    Individual Cancellation

    72 hours prior to 23:59 local time of the day of arrival to check-in to avoid one night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    Discover the culture of the Crescent City at Hyatt Regency New Orleans. Centered downtown near Champions Square, Smoothie King Center, and minutes from the historic Mississippi Riverfront. There's no better place from which to explore the eclectic vibrancy of New Orleans.

    Hyatt Regency New Orleans is conveniently located near many popular attractions. They’re only a few minutes walk from the French Quarter and the Arts District. Or hop on the city’s famous streetcars — the Loyola line stops directly outside the hotel.

How to Get Here

By Air

Louis Armstrong New Orleans International Airport (MSY) is approximately 15 miles (24km) from the hotel and all major carriers service this airport. Taxi fares from MSY are approximately $36 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency New Orleans is located at 601 Loyola Avenue, New Orleans, LA 70113. Valet parking is offered at the hotel and there are several nearby parking lots, including the 1301 Girod Parking Garage that connects directly to the hotel. Contact Merit Parking to confirm pricing: +1 (504) 561-0575.

Other Options

Hyatt Regency New Orleans is happy to partner with a local shuttle service to make your trip to and from the Louis Armstrong New Orleans International Airport easy. To learn more and to reserve your spot at least 24 hours prior to your flight arrival time, visit airportshuttleneworleans.com/portals/hyatt-regency-new-orleans.

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Registration Fees

Early Registration
Registration Type Price By February 20, 2023
Member $899
Non-member $1,079
Gov't/Health Auth./Academic $699

Regular Registration
Registration Type Price After February 20, 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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