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  4. 2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality - 09/14/2021
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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:
Tue, Sep 14 11:00 a.m. - 05:35 p.m. ET
Day2:
Wed, Sep 15 11:00 a.m. - 05:15 p.m. 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.

Agenda and Bios

Presentation Title and Slides Presentation Description

Pre-conference Session: Compounding Law and Policy 

 

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 

 

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.  

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.  

Analytical Testing for Compounded Drugs  

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.  

 

Quality Management Systems (Not FDA)  

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.

Compounding Policy Updates*

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.

 

 

483s Responses and Reinspection  

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.  

 

Elevating SOPs and Work Aids 3 (Not FDA)  

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. 

 

Stability/BUDS: Science and Guidance  

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.

Future of Outsourcing Facility Compounding  

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.

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