Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence
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FDA’s Compounding Quality Center of Excellence supports building networks and fostering a culture of quality within the industry.
Supporting Outsourcing Facilities
Outsourcing facilities that participate in the Center of Excellence help promote quality across the industry by collaborating and learning with other outsourcing facilities and stakeholders who provide valuable insights. Patient safety is our shared responsibility, and industry partners play a role in ensuring that only quality compounded drugs reach patients.
Engaging with other outsourcing facilities and across the broader health care community provides many benefits to the industry, including sharing common issues and practices and finding solutions. We look forward to a productive dialogue as we collaborate to fulfill our shared responsibility to ensure that only quality compounded drugs reach patients.
Opportunities to Collaborate
The Center of Excellence offers two discussion series - one for newly registered outsourcing facilities and one focused on quality, and we encourage outsourcing facilities and related stakeholders to get involved.
New Outsourcing Facility Discussion Series upcoming events
The New Outsourcing Facility Discussion Series is tailored to newly registered outsourcing facilities. The goal of this series is to educate new outsourcing facilities and build a community among all outsourcing facilities to share knowledge across the industry. These discussions will take place several times a year and will provide opportunities for newly registered outsourcing facilities to learn from more experienced outsourcing facilities.
Who should attend:
- Outsourcing facilities management and staff
- Consultants helping newly registered outsourcing facilities
- Compounders interested in becoming outsourcing facilities
August 25, 12-1:30 p.m. ET: Developing a Product Portfolio
Are you a newly registered outsourcing facility deciding which drugs to produce? Developing your portfolio can be challenging yet it is a fundamental part of starting a new outsourcing facility. Join our discussion with outsourcing facility executives and a group purchasing organization about developing a portfolio, including how to maintain and evolve a portfolio and how customer relationships and operational capacity factor into decision making.
November: Automation Basics
Registration information is coming soon.
Are you looking at ways to increase efficiencies? There are several ways to automate your business and operations to increase efficiency and improve quality. Join us to hear from outsourcing facility executives and consultants about these considerations when incorporating automation in your outsourcing facility’s processes and procedures. This discussion will provide an overview of the types of automation that can be incorporated into a facility as well as the potential benefits and challenges to implement these changes.
Quality Discussion Series upcoming events
The Quality Discussion Series is tailored for outsourcing facilities interested in advancing quality and will focus on topics related to quality culture and best practices. These discussions will take place several times a year and aim to build a robust community of outsourcing facilities with a strong commitment to quality and current good manufacturing practice requirements. This series also provides the industry with an opportunity to share quality practices across the industry that positively impact patient safety.
Who should attend:
- Outsourcing facilities management and staff
- Purchasers of compounded drugs
- Pharmacy organizations
September 24, 12-1:30 p.m. ET: Quality Beyond the Quality Unit
Integrating a robust quality system into all aspects of an outsourcing facility improves the quality of drugs and potentially reduces adverse actions at the facility. Join us for a discussion with outsourcing facility executives and consultants on how to embed quality across the organization. This panel will provide insight into how outside entities perceive quality at the facilities they or their customers purchase from. This discussion will help outsourcing facilities gather insight on ways to improve quality throughout their operation.
January: Integrating Automation for Quality Outcomes
Registration information is coming soon.
Are you incorporating automated systems in your facility but concerned about how to increase quality outcomes using automated systems? Automation systems implemented correctly can provide a more robust quality system and improve drug quality. Hear from outsourcing facility executives and consultants who will share their perspectives on how they manage change as they balance incorporating automation with promoting quality and maintaining current good manufacturing practice requirements and the quality considerations of incorporating potential efficiencies.
Cross-Sector Stakeholder Group
Additionally, the Cross-Sector Stakeholder Group is a small group of industry experts who discuss issues impacting outsourcing facilities, such as drug shortages and the future of the industry.