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  4. 2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality - 09/14/2021 - 09/15/2021
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Event Title
2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality
September 14 - 15, 2021

September 14 - 15, 2021
- ET
- ET

The virtual conference will bring 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.


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)


September 14-15, 2021

An optional pre-conference session geared toward first time attendees will be held on September 13, 2021.


The 2021 Compounding Quality Center of Excellence will take place virtually. Find registration information below.


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


Registration is tentative until approved. Conference registration is free and includes access to our interactive platform as well as live sessions and presentations. Early registration is recommended.

Register Here

We will update the schedule closer to the conference date with a more detailed view of the agenda that includes educational sessions, presentations and ways to engage the industry. Some sessions may be subject to change.

All times listed below are in Eastern Time (ET).

DAY 1: Tuesday, September 14



11:00 am – 11:15 am

Opening Plenary: Welcome & Opening Remarks 


11:15 am – 12:15 pm Opening Plenary: Keynote – Promoting Culture of Quality 

12:15 p.m. – 12:45 p.m.


12:45 p.m. –  2:00 p.m.

What to Expect on a 503B Inspection - From Initiation to Closeout


2:00 p.m. – 2:15 p.m.


2:15 p.m. – 3:15 p.m.

FDA Approvals: 505(b)(2) and ANDA Pathways


3:15 p.m. – 3:45 p.m.


3:45 p.m. – 4:45 p.m.

Stability/BUDS: Science and Guidance

Elevating SOPs and Work Aids 


4:50 p.m. – 5:35 p.m.

Compounding Policy Updates


DAY 2: Wednesday, September 15



11:00 a.m. – 12:00 p.m.

Cross-Sector Panel: Outsourcing Facilities and Purchasers


12:00 p.m. – 12:30 p.m.


12:30 p.m. – 1:30 p.m.

FDA Form 483, Responses and Beyond


1:30 p.m. – 2:00 p.m.


2:00 p.m. – 3:00 p.m.

Quality Management Systems 


Analytical Testing for Compounded Drugs

3:00 p.m. – 3:30 p.m.


3:30 p.m. – 4:45 p.m.

Closing Plenary: The Future of Outsourcing Facility Compounding


We will also offer an optional pre-conference session the day before the conference begins to provide a background on federal law and policy applicable to compounded drugs, geared towards first-time attendees.

Pre-Conference Session: Monday, September 13



 2:00 p.m. – 4:00 p.m.

Compounding Law and Policy

Continuing Education Credits

Continuing education credits will be available. More information on receiving continuing education credits will be available prior to the conference.


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.

Event Materials

Title File Type/Size
Agenda: COE_2021_Conference Agenda>pdf pdf (83.78 KB)
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