Virtual | Virtual
Event Title
2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality
September 14 - 15, 2021
- Date:
- September 14 - 15, 2021
- Day1:
- - ET
- Day2:
- - ET
The virtual conference brings together outsourcing facilities, regulators and industry leadership to engage on emerging industry topics and best practices to improve the overall quality of compounded drugs, focusing on a culture of quality.
Presentation Title and Slides | Presentation Description |
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Pre-conference Session: Compounding Law and Policy
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This session provides an introduction to FDA’s compounding program, including sections 503A and 503B of Federal Food Drug and Cosmetic Act and key FDA policies on compounding. Geared toward first time conference attendees or participants new to the field, this introductory session provides a foundation for conference sessions. |
Keynote Promotion Culture of Quality
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Quality culture within an organization is critical to the production of quality products and to sustained compliance. This session discusses the cultural value base of the industry, emphasizing the importance of leadership and management buy-in to ensure a culture of quality is adopted and implemented. |
The presentations covers the inspection processes and what facilities should expect during a 503B inspection, from initiation to completion. |
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During this session, FDA provides an overview of the 505(b)(2) and ANDA market authorization pathways. Learn about the steps required to pursue an application, the differences between the two market authorization pathways, and the type of data FDA may require to support these applications. |
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This session covers analytical testing related to compounded drugs produced at outsourcing facilities. The presentation focuses on best practices for conducting analytical testing, documenting and reviewing analytical results, and adequately maintaining analytical records.
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This session will provide an overview of the principles of Quality Management Systems and insights to firms seeking to adopt or strengthen these systems internally. |
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Representatives from FDA’s Office of Compounding Quality and Compliance (OCQC) provide updates on current and upcoming regulations, policies, and guidance related to drug compounding. The briefing covers policy updates that occurred in the past year. * Please see update regarding the memorandum of understanding between FDA and states addressing certain distributions of compounded human drug products.
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This session highlights the Form FDA 483, Inspectional Observations, and provides an overview of the considerations for inspection classification and reinspection. This session incorporates real-world case studies.
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Gain essential insights on how to develop effective SOPs and work-aids within the pharmaceutical industry. Participants learn about principles related to designing the work, engaging workers in the development process, and human error reduction. Content also focuses on the role of standardization, and principles for document revision management and training as well as the important role of the supervisor/management in implementing use of SOPs and work aids.
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FDA discusses guiding principles in regulation and guidance related to conducting stability studies and establishing beyond-use dating. Content will also focuses on the science underlying the evaluation of stability and the risks when these evaluations are not conducted in a robust manner. |
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FDA discusses the future and identity of the outsourcing facility industry, and what panelists expect in the compounding world over the coming years. |
The conference will provide opportunities for you to:
- Discuss the importance of having a culture of quality in outsourcing facilities
- Expand knowledge of current good manufacturing practice (CGMP) and key policies
- Enhance understanding of inspectional processes and regulatory requirements
- Listen to diverse stakeholder perspectives on the future of the outsourcing facility sector
- Build knowledge of compounding law and policy, for those new to the industry (pre-conference session)
Date
September 14-15, 2021
An optional pre-conference session geared toward first time attendees will be held on September 13, 2021.
Location
The 2021 Compounding Quality Center of Excellence will take place virtually. Find registration information below.
Agenda
View the Schedule At-A-Glance for a general overview of the conference schedule as well as the types of sessions offered:
Final Agenda (PDF - 77 KB)
Virtual Conference Agenda
This year’s conference sessions relate to the importance of working together to ensure the culture of quality in the compounding industry. All sessions were developed with a focus on improving the quality of compounded drugs to promote patient safety. Hear viewpoints from FDA and industry leaders and gain knowledge of the field’s path forward.
Take advantage of interactive and educational sessions.
Culture of quality
Hear from industry leaders on building and sustaining a culture of quality in outsourcing facilities, including what quality means to them and how they implemented quality in their field.
CGMP sessions
Learn from experts about current good manufacturing practice (CGMP) expectations and best practices, including deep-dive sessions on Quality Management Systems, Stability Evaluation, and establishing robust SOPs.
Compounding policy updates
Hear from FDA about the latest policies applicable to drug compounding, including compounding during COVID-19 and the use of bulk drug substances.
Intended Audience
The virtual conference is recommended for the following audience:
- Outsourcing Facilities
- Compounding pharmacies with interest in the outsourcing facility sector
- State Pharmacy Regulators
- Hospital pharmacies
- Physician specialties using compounded drugs
- Purchasers and insurers
Continuing Education Credits
Continuing education credits will be available. More information on receiving continuing education credits will be available prior to the conference.
Questions
Please contact the Compounding Quality Center of Excellence with any questions.
We look forward to you attending the 2021 Compounding Quality Center of Excellence Virtual Conference.