PDA 621 Introduction to the Quality Risk Management Master Plan

Edmonds, WA
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This training course will provide an overview of the QRM process with an emphasis on the principles in ICH Q9 (R1) 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. The concept of the Quality Risk Management Master Plan will also be introduced, as a mechanism to build a new risk program, align with evolving expectations, and strategize.

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.

Upon completion of this training course, the attendee will be able to:

  1. Identify and explain all facets of the ICH Q9(R1) Quality Risk Management life cycle
  2. Attendees will gain exposure to QRM tools available to perform risk assessments as well as an overview of heuristics that one might encounter during performance of an assessment
  3. Attendees will gain tactical knowledge on how to organize and streamline their organization’s risk portfolio to align with new expectations of the revised ICH Q9 (R1) and how to build a QRM Master Plan in support of that goal
  4. Attendees will learn how to leverage the QRM Master Plan to aid innovation and benefit from efficiencies gained through manufacturing process improvement
  5. Attendees will gain insight on contamination control strategy supporting risk assessments to align with the revised Annex 1 with suggested risk questions and tools

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

Standard Registration

Member Price

$399

GovernmentMember Only

$279

Health AuthorityMember Only

$279

AcademicMember Only

$279

Non-Member

$479

See Qualifying Criteria for Member Types.

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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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.

Accommodations

The following hotels are located near the training course location:

Embassy Suites by Hilton Seattle North Lynnwood
20610 44th Ave W
Lynnwood, WA 98036

Hilton Garden Inn Seattle/Lynnwood
3801 Alderwood Mall Blvd
Lynnwood, WA 98036

Hampton Inn & Suites Seattle-North/Lynnwood
19324 Alderwood Mall Pkwy
Lynnwood, WA 98036

How to Get Here
By Air The nearest airport to the training course location is the Seattle-Tacoma International Airport (SEA).
By Car There is a parking lot available at the training course location.