Virtual | Virtual
Event Title
Compounding Quality Center of Excellence Annual Conference
September 6 - 8, 2022
- Date:
- September 6 - 8, 2022
Our 2022 conference highlighted how stakeholders can protect patients from unsafe, ineffective, and poor-quality compounded drugs while preserving access to compounded drugs for patients who have a medical need for them. Slide presentations and recorded videos with captions are available on this page.
Presentation Title and slides |
Watch the recorded session |
Description |
Pre-conference session, Sept. 6, 2022
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Outsourcing Facility Nuts and Bolts: Reporting, Registration, and Other Topics, time 2:20:20 |
FDA presents an overview of logistical elements, including product reporting, registration, pre-inspection meeting requests, inspections, and posting to the bulk nomination and general compounding dockets. |
Compounding Quality Center of Excellence 2022 Conference: Opening Plenary, Sept. 7, 2022 |
Opening plenary including panel discussion, Aligning on Compounding Excellence: Understanding Its Meaning Across the Sector, time: 1:02 |
Panel discussion of what compounding ‘excellence’ means to a diverse group of stakeholders. |
Characteristics of Pharmaceutical Elastomers in Container Closure Systems, Sept. 7, 2022
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Container Closure Systems, time: 58:11 |
Presentation on qualifying container closure systems for intended use. |
Visual Inspection of Injectable Products, Sept. 7, 2022 |
Visual Inspection, time: 59:04 |
Presentation on visual inspection practices and related current good manufacturing practice (CGMP) regulations, including examples of FDA Form 483 observations and potential responses. |
Areas of Customer Need for Outsourcing Facility Products, Sept. 7, 2022
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Areas of Need Roundtable, time: 48:33 |
Panel discussion with external stakeholders to discuss the areas of need for drug products compounded by outsourcing facilities, including FDA-sponsored research on stakeholder perspectives. |
Virtual Breakout Sessions, Sept. 7, 2022
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No recording |
Moderated breakout rooms:
|
FDA Hot Topics Panel Discussion, Sept. 8, 2022 |
FDA Hot Topics, time: 50:36 |
Panel discussion on current Agency topics of interest to outsourcing facilities. |
Hospital and Health System Compounding Under Section 503A of the FD&C Act, Sept. 8, 2022
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Hospital and Health System Guidance, time: 39:17 |
Presentation on revised draft compounding guidance for health systems. |
Roundtable Discussion — 503B Hospital Panel: How are Outsourcing Facilities Evaluated by Prospective Customers? Sept. 8, 2022
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503B Hospital Panel; time: 54:20 |
Panel discussion on hospital and health system approaches to evaluating and selecting outsourcing facility partners. |
Building Connections Co-Presentation, Sept. 8, 2022
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Perspectives from the Field, time: 41:24 |
Case study presentation highlighting stakeholder collaboration to address patient needs |
Building Connections: Advancing Our Shared Pursuit of Compounding Quality, Sept. 8, 2022
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Closing panel, time: 1:04:26 |
Moderated panel on building cross-sector connections to advance compounding excellence. |