PDA 621 Introduction to the Quality Risk Management Master Plan
Registration Options
Individual Registration
Group Registration
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:
- Identify and explain all facets of the ICH Q9(R1) Quality Risk Management life cycle
- 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
- 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
- Attendees will learn how to leverage the QRM Master Plan to aid innovation and benefit from efficiencies gained through manufacturing process improvement
- 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):
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Standard Registration
Member Price
$399GovernmentMember Only
$279
Health AuthorityMember Only
$279
AcademicMember Only
$279
Non-Member
$479
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 registration@pda.org.
Featured Trainers
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Tiffany A. Baker, MBA
ValSource Inc.
Read Bio
Tiffany A. Baker, MBA
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.
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Edmonds Yacht Club
326 Admiral WayEdmonds, WA 98020, USA
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