Conference | Mixed

Event Title

2024 Compounding Quality Center of Excellence Annual Conference

August 21 - 23, 2024

Learning and Collaborating: Driving Toward the Future of Quality

Date:: August 21 - 23, 2024
Day1:: Wed, Aug 21
Day2:: Thu, Aug 22
Day3:: Fri, Aug 23

Our 2024 conference convened stakeholders from across the compounding industry to discuss emerging trends and best practices through presentations, panels, and interactive sessions. It included In-depth sessions on current good manufacturing (CGMP) topics and leveraging knowledge and building partnerships for the future. Links to recorded videos with captions are available in the table below.

2024 Conference Agenda

Watch the recorded session	Description
Pre-conference session – Developing a New Outsourcing Facility: Lessons Learned Time: 2:37:04	Learn from established outsourcing facility leaders about the challenges of forming a new outsourcing facility and keys for success. Perspectives will include a hospital system-owned outsourcing facility, a 503A pharmacy that transitioned to an outsourcing facility, an outsourcing facility developed within a pharmaceutical company, and an outsourcing facility formed as a start-up. A panel discussion will share experiences interacting with newly formed outsourcing facilities.
Welcome and Opening Remarks Time: 14:45	Day 1 Welcome and Opening Remarks
Opening Plenary – Learning and Growth: Successes and Challenges of a Developing Industry Time: 1:15:43	This session explores the evolution of the outsourcing facility industry, including quality and factors influencing long-term viability.
The Business Case for Quality and Resilience Time: 1:02:50	Panelists discuss perspectives from outsourcing facilities and customers on the benefits of investing in quality and resilience.
Session 1a Risk Assessment in Aseptic Processing Time: 58:45	Learn risk assessment tools for assessing aseptic processing operations that leverage technologies to increase sterility assurance.
Session 1b Investigating Environmental Monitoring Excursions Time: 54:58	Analyze an investigation of an environmental monitoring excursion highlighting critical aspects, such as microbiology and risk evaluation of the facility.
Session 1c Visual Inspection Time: 1:00:57	Learn the importance of visual inspection and review basic concepts illustrated with case studies.
Session 1d Testing: Industry Perspectives Time: 57:26	Explore the advantages and disadvantages of utilizing internal vs. external testing. Examine processes for handling out-of-specification and out-of-trend results.
Pediatric Considerations for Outsourcing Facilities Time: 1:12:54	Discover how outsourcing facilities can be well positioned to meet many of the unique needs of children’s hospitals. Learn how collaboration can ensure pediatric access, quality, and safety.
Assessing Quality Time: 59:25	Gain exposure to strategies and cases studies for internally assessing quality and the state of control within the framework of section 503B and CGMP.
Session 2a Reframing Perspectives via CGMP Training Time: 1:01:40	Gain understanding about how the training provided in pharmacy and other industries may not align with CGMP thinking. Learn how to align the thinking across the disciplines.
Session 2b Data Integrity Time: 57:30	Gain understanding about how the training provided in pharmacy and other industries may not align with CGMP thinking. Learn how to align the thinking across the disciplines.
Session 2c Navigating State Laws and Regulations Time: 1:02:15	Learn about variable state laws and regulations. Get updates on the latest potential state requirements and trends as they pertain to outsourcing facilities.
Session 2d Contamination in Control Operations Time: 59:45	Review contamination control practices for aseptic processing. Consider concepts and strategies for cleaning and disinfection of classified areas, disinfectant efficacy testing, commodity and component packaging, material transfer, and residue mitigation.
Session 3a Developing an Effective Training Program Time: 1:03:48	Learn strategies for developing an effective training program, such as implementation, methodologies, retraining, and connecting initial training to daily work activities.
Session 3b Not Just Blowing Smoke: Why Smoke Studies are Critical Time: 59:49	Explore the concept of airflow visualization and critical considerations to ensure an optimum smoke study. Examine standards, regulations, and guidance for airflow visualization, as well as examples demonstrating poor airflow and good airflow.
Session 3c The Role of the Pharmacist in the Realm of Outsourcing Facilities Time: 1:03:54	Explore the role of the pharmacist in the context of outsourcing facilities and health system pharmacies that interact with outsourcing facilities.
Session 3d Automation: Environment and Facility Considerations Time: 1:03:14	Discover the advantages of incorporating restrictive access barrier (RABs) into aseptic processing operations and when it makes sense to incorporate RABs into a facility. Consider facility design, environmental controls, and aseptic practices considerations.
Impact of Compliance on Product and Patient Time: 1:00:06	Explore the differences and interplay between quality and compliance. Learn from examples that illustrate the impact of non-compliance on the product and patient.
Excipient Quality Time: 44:16	Get an overview of excipients within the context of sterile compounding and understand the importance of excipient quality.
Sustaining and Building the Future of Quality Across Networks Time: 50:15	Learn about tools available to outsourcing facilities and how to leverage knowledge and create partnerships for the future.
Closing Remarks Time: 6:12