Skip To The Main Content

Technical Report No. 54: Foundations of Quality Risk Management

May 04, 2020
Bethesda, MD

  • Education
  • The Americas

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

Agenda

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

Trainers

Amanda M. McFarland
Amanda M. McFarland
ValSource Inc.

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

    Who Should Attend

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

    Departments
    Quality Assurance, Manufacturing, Quality Control

    Roles
    Specialist, Supervisor, Manager

Got a Question? We have answers

Contact Us

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 March 20, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price After March 20, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* 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].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

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]

PDA Members Save Substantially