Compounding Quality Center of Excellence Virtual Conference: Working Together for Patient Safety - 09/21/2020 - 09/22/2020

Bringing together current and future outsourcing facilities, regulators and other compounding experts and stakeholders to learn and engage on key topics and best practices.

Date:

September 21-22, 2020

Location:

The web link to the virtual conference will be sent via email to participants a few days prior to the conference.

Hear viewpoints from FDA and industry on diverse topics including policies and experiences during COVID-19, current good manufacturing practices (CGMP), automation technology and more. The conference will offer a mix of interactive and educational sessions to allow the outsourcing facility and stakeholder community to engage on key issues in the field.

Dr. Stephen M. Hahn, Commissioner of Food and Drugs to provide welcoming remarks.

Take advantage of interactive and educational sessions

Compounding during COVID-19: Focus on patient safety and access
Hear first-hand experiences from the hospital, outsourcing facility and regulatory perspectives on the use of compounded drugs to meet the needs of COVID-19 patients when FDA-approved drugs are not available.

CGMP foundations and deep dive sessions
Learn from experts about current good manufacturing practice (CGMP) expectations for outsourcing facilities, including deep-dive sessions on active pharmaceutical ingredient (API) sourcing and process validation.

Culture of quality
Hear from industry leaders on building and sustaining a culture of quality, including what quality means to them and how they have implemented quality in their field.

Compounding policy updates
Hear from FDA about the latest policies applicable to drug compounding, including the use of bulk drug substances and temporary guidances issued in response to the pandemic.

Intended Audience

Outsourcing facilities and compounders who are considering becoming an outsourcing facility
State and federal regulators
Representatives from related stakeholder groups such as trade and professional associations, purchasers and suppliers.

Continuing Education Credits

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

Agenda: September 21, 2020

Time (EST)	Topic
10:30 a.m. – 10:40 a.m.	Opening remarks from Commissioner Hahn
10:40 a.m. – 10:50 a.m.	Opening remarks from Donald D. Ashley, Director, CDER Office of Compliance
10:50 a.m. – 11:45 a.m.	Compounding during COVID-19: Patient safety and access
12:00 p.m. – 1:00 p.m.	CGMP Foundations
1:15 p.m. – 2:00 p.m.	CGMP: Process validation	CGMP: API sourcing
2:15 p.m. – 3:00 p.m.	Bulk drug substances and FDA evaluation
3:15 p.m. – 4:15 p.m.	FDA policy update: Recent and relevant guidances
4:30 p.m. – 5:30 p.m.	Closing plenary: Instilling a culture of quality

Agenda: September 22, 2020

Time (EST)	Topic
10:30 a.m. – 11:20 a.m.	The future of compounding: Outsourcing facility perspective
11:40 a.m. – 11:50 a.m.	Opening remarks from Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco Operations
11:50 a.m. – 1:00 p.m.	Here and now: Inspectional processes and COVID-19 updates
1:15 p.m. – 2:00 p.m.	Responding to FDA Form 483
2:15 p.m. – 3:05 p.m.	Incorporating automation and technology into compounding
3:15 p.m. – 4:00 p.m.	A case for automation: An outsourcing facility’s journey	GPO Perspectives: Insights for outsourcing facilities
4:15 p.m. – 5:00 p.m.	Closing plenary: Building the future of compounding