Technical Report No. 54: Foundations of Quality Risk Management
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Individual Registration
Group Registration
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.
- Describe the Quality Risk Management (QRM) process and explain the roles and responsibilities
- Describe when, where and how to apply risk management throughout the product lifecycle
- Plan and prepare for quality risk management activities
- Describe the formality associated with QRM tools
- Building a QRM program at your company
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Standard Pricing
Standard Member Price
$999GovernmentMember Only
$999
Health AuthorityMember Only
$999
AcademicMember Only
$999
Non-Member
$999
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].
Day 1
An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.
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Raleigh Convention Center
500 South Salisbury StreetRaleigh, NC , USA
Please visit the hotel’s website for more information.