Pre-Conference Quality Essentials

• Quality Culture
• Quality Essentials
• Inspectional Coverage

Pre-Conference Quality Essentials time: 2:31:13

FDA presentations followed by questions and discussion that will explore fundamental concepts in quality, including Quality Unit formation and operation, as well as an overview of quality management systems, quality risk management, and their integration into firms’ practices.

Opening Plenary: Ten Years of Regulated Outsourcing Facilities: A Decade of Progress, But More To Do  

Opening Plenary time: 1:23:54

In this session, our presenter, moderator and panelists discuss progress in the outsourcing facility industry over the past ten years as well as challenges that remain within the industry, with an emphasis on quality.

Guidance: FDA Updates and Impact of Stakeholder Input on FDA Guidance Development

• Wholesaling
• FDA Guidance
• Stakeholder Feedback

Updates on FDA Guidance for Industry time: 1:00:26

In this session, members of the Division of Compounding Policy and Outreach provide updates on FDA guidance pertaining to compounded drugs. They also give an overview of the guidance development process and discuss how stakeholder input impacts the development of FDA guidance.

503Bs as Partners to Providers (no slides)

503Bs as Partners to Providers time: 58:27

This session, Stakeholder Perspective: 503Bs as Partners to Providers: Benefits and Challenges, is a panel discussion exploring the benefits and challenges of utilizing 503Bs from industry and customer perspectives.

Quality Throughout the Supply Chain (no slides)

Quality Throughout the Supply Chain time: 58:17

In this session of the Compounding Quality Center of Excellence 2023 Conference, Quality Throughout the Supply Chain, we host a roundtable discussion on maintaining quality throughout the supply chain. The panel offered perspectives of suppliers, from raw material acquisition through production, and of customers.

Shortages and Lessons Learned (no slides)

Shortages and Lessons Learned time: 58:25

In this session of the Compounding Quality Center of Excellence 2023 Conference, Shortages and Lessons Learned, a panel of FDA and industry experts discuss lessons learned through recent shortages during COVID and other acute illness outbreaks and how outsourcing facilities might be utilized to bridge gaps for both short-term and long-term drug shortages.

Managing State Regulatory Challenges

Managing State Regulatory Challenges time: 53:31

In this session of the Compounding Quality Center of Excellence 2023 Conference, Managing State Regulatory Challenges, Gregg Jones of the National Association of Boards of Pharmacy, gives a presentation on recommendations for navigating varied state regulatory requirements for outsourcing facilities and explore challenges from states’ perspectives in harmonizing regulatory requirements.

Stakeholder Perspective: Purchasing and Forecasting: How it Works

Purchasing and Forecasting time: 55:49

In this session of the Compounding Quality Center of Excellence 2023 Conference, Stakeholder Perspective: Purchasing and Forecasting: How it Works, Kevin Hansen of Premier Inc., gives a presentation on methods used for demand forecasting and the importance of transparency between purchasers and suppliers. A panel discussion follows the presentation.

Product Complaints and Investigations

• Incident Management
• Complaint Investigations

Product Complaints and Investigations time: 1:15:37

In this session of the Compounding Quality Center of Excellence 2023 Conference, Product Complaints and Investigations, three FDA staff give a presentation on how to address product complaints and how to design and conduct robust investigations.

Process Validation and Automation

Process Validation and Automation 1:14:32

In this session of the Compounding Quality Center of Excellence 2023 Conference, Process Validation and Automation, FDA gives a presentation on general principles and approaches of process validation and the importance of ensuring control in the manufacturing process to produce consistent, quality products for patients. This presentation aligns process validation activities with a product lifecycle concept and existing FDA guidance documents for industry. There will be an industry/FDA panel discussion on the challenges facing our industry as they relate to automation and equipment validation.

Questions and Discussion With FDA (no slides)

Questions and Discussion With FDA time 59:47

In this session of the Compounding Quality Center of Excellence 2023 Conference, Questions and Discussion With FDA, several FDA compounded drug experts discuss how companies may receive responses from FDA to address their questions and issues, and the ways in which FDA is able to respond. A large portion of the session was reserved as an open question and answer period with conference participants.

Closing Plenary: The Next Ten Years (no slides)

The Next Ten Years time: 1:05:25

In this session of the Compounding Quality Center of Excellence 2023 Conference, Closing Plenary: The Next Ten Years, a panel of FDA and industry experts provides industry and stakeholder perspectives on goals and visions for industry in the next ten years. Closing remarks by Gail Bormel follow the panel discussion.