11:15 AM – 11:45 AM (30 minutes) | Presentation
11:45 AM – 12:30 PM (45 minutes) | Panel Discussion

Presentation on progress made in the outsourcing facility industry over the past ten years as well as challenges that remain within the industry, with an emphasis on quality. Panel with FDA and industry representatives will follow.

12:45 PM – 1:45 PM (60 minutes) | Presentation
1:45 PM – 2:00 PM (15 minutes) | Open Questions and Discussion

Updates on FDA guidances as well as an overview of the guidance development process and how stakeholder input impacts the development of guidances.

2:15 PM – 3:15 PM (60 minutes) | Panel Discussion

Panel discussion that will explore the benefits and challenges of utilizing 503Bs from both the industry and customer perspectives.

3:45 PM – 4:45 PM (60 minutes) | Panel Discussion

Roundtable discussion on maintaining quality throughout the supply chain. The panel will offer both the supplier perspective, from raw material acquisition through production, and the customer perspective.

3:45 PM – 4:45 PM (60 minutes) | Panel Discussion

Panel to discuss lessons learned from recent shortages during COVID and other acute illness outbreaks and how outsourcing facilities might be utilized to bridge gaps for both short-term and long-term drug shortages.

4:50 PM – 5:20 PM (30 minutes) | Presentation
5:20 PM – 5:35 PM (15 minutes) | Open Questions and Discussion

Presentation to discuss recommendations for navigating varied state regulatory requirements for outsourcing facilities and explore challenges from states’ perspectives in harmonizing regulatory requirements.

11:00 AM – 11:30 AM (30 minutes) | Presentation
11:30 AM – 12:00 PM (30 minutes) | Panel Discussion

Presentation to discuss methods used for demand forecasting and the importance of transparency between purchasers and suppliers. Panel discussion to follow.

12:30 PM – 1:30 PM (60 minutes) | Presentation
1:30 PM – 1:45 PM (15 minutes) | Open Questions and Discussion

Presentation that will include how to address product complaints as well as how to design and conduct robust investigations.

12:30 PM – 1:15 PM (45 minutes) | Presentation
1:15 PM – 1:45 PM (30 minutes) |Open Questions and Discussion

Learn general principles and approaches of Process Validation and the importance of ensuring control in the manufacturing process to produce consistent, quality products for patients. This presentation aligns process validation activities with a product lifecycle concept and existing FDA guidance documents for industry. There will be an industry/FDA panel discussion on the challenges facing our industry as they relate to automation and equipment validation.

2:00 PM – 3:00 PM (60 minutes) | Panel Discussion

FDA panel that will discuss how companies may receive responses from FDA to address their questions and issues, and the ways in which FDA is able to respond. A large portion of the session will be reserved as an open question and answer period with conference participants.

3:30 PM – 4:30 PM (60 minutes) | Panel Discussion

Panel that will provide both industry and stakeholder perspectives on goals and visions for industry in the next ten years.

Panel discussion of what compounding ‘excellence’ means to a diverse group of stakeholders.

Presentation on visual inspection practices and related Current Good Manufacturing Practice (CGMP) regulations.

Presentation on qualifying container closure systems for intended use.

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.

Moderated breakout rooms focused on different topics:

1. Understanding Form FDA 483 Process and Timeline
2. Product Reporting, Registration, and Other Requirements
3. Quality Risk Management
4. Automation

Panel discussion on current Agency topics of interest to outsourcing facilities.

Presentation on revised draft compounding guidance for health systems.

Panel discussion on hospital and health system approaches to evaluating and selecting outsourcing facility partners.

Case study presentation highlighting stakeholder collaboration to address patient needs.

Moderated panel on building cross-sector connections to advance compounding excellence.