
PDA 529.1 Technical Report No. 54: Foundations of Quality Risk Management
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Registration Options
Individual Registration
Group Registration
This live eLearning training course will provide an overview of the Quality Risk Management (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.
- Describe the 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
- Build a QRM program at your company
Agenda
Discover What's Happening Each Day
Introduction and Objectives (20 min)
Section 1: What is Risk Management? (55 min)
Break (15 min)
Section 2: Applications of QRM (90 min)
Review and Reflection (20 min)
Section 3: QRM Tools / Section 4: Risk Assessment Outputs: Now What? (55 min)
Break (15 min)
Section 5: Building a QRM Program at Your Company (60 min)
Open Discussion (30 min)
Registration
Pricing Options
Standard Registration
Member Price
$599GovernmentMember Only
$599
Health AuthorityMember Only
$599
Early Career ProfessionalMember Only
$599
StudentMember Only
$599
AcademicMember Only
$599
Non-Member
$599
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Become a Sponsor and/or Exhibitor
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Become a Sponsor
Elevate your brand and maximize your exposure by becoming a sponsor at the PDA 529.1 Technical Report No. 54: Foundations of Quality Risk Management! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
Request InformationBecome an Exhibitor
Boost your brand and visibility by becoming an exhibitor at the PDA 529.1 Technical Report No. 54: Foundations of Quality Risk Management! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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