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Compounding Quality Center of Excellence | On-demand Training

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The FDA Compounding Quality Center of Excellence is providing anytime, anywhere training to support outsourcing facilities and other stakeholders in their efforts to enhance the quality of compounded drugs. FDA offers self-guided online courses offering continuing education, webinar recordings, and presentation slides on compounding topics.

The following categories of training are freely available to the public.

Self-Guided Online Trainings

  • Participants may complete these free courses at their own pace. Some courses are microlearnings, less than an hour and others are more in-depth lasting a few hours. Each course provides continuing education credits for pharmacists, physicians and nurses.

Presentations

  • Select presentations from events such as the annual conference.

Self-Guided Online Trainings

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Training

Description

Format

Continuing Pharmacist, Physician, and Nurse Education Credits

Sterility Testing: Common Misconceptions This course provides an overview of sterility testing, including the impact of loss of sterility on patient safety and product quality, common misconceptions, critical elements of sterility testing, and investigating sterility test failures.
 
Self-Guided .75 hours


Regulatory Framework for Human Drug Compounding

Enhance your understanding of federal law and policies applicable to human drug compounding, including an introduction to human compounding, a brief regulatory history and the differences between sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The course also covers FDA inspection process and compounding oversight, such as FDA Form 483s, warning letters and regulatory meetings.

Self-guided

1.5 hours

Outsourcing Facility Guide

Discover important regulatory information about the requirements specific to outsourcing facilities and practical information for areas such as registration for compounders that want to become outsourcing facilities and adverse event reporting. Other topics include the requirements in section 503B of the FD&C Act and an overview of the major topics covered in key guidance documents.

Self-guided

1.75 hours

Investigations and Corrective and Preventive Actions (CAPA)

Learn how to conduct investigations and formulate CAPAs. Discover elements that trigger investigations, investigative tools, developing and implementing CAPAs, verifying effectiveness of CAPAs and initiating and completing investigations and CAPAs.

Self-guided

5 hours

Supplier/Contractor Qualification and Management

Learn how to select, qualify, manage, and audit suppliers and contractors. Topics covered by this course include regulations, guidance documents, and best practices to improve the production of quality drug products. Participants will also learn about the concept of supplier/contractor qualification and management lifecycles.

Self-guided

4 hours

Insanitary Conditions and Sterility Assurance 

Learn how to improve sterility assurance and prevent insanitary conditions to protect patient health. This course covers how insanitary conditions relate to sterility assurance, the most commonly encountered insanitary conditions in non-sterile and sterile drug production facilities and the consequences of each, the “systems approach” to sterility assurance and preventing insanitary conditions, as well as how to identify, mitigate, and correct insanitary conditions.

Self-guided

4 hours

Personnel Gowning in Sterile Drug Production

Learn the importance of maintaining sterile gowning components. Discover the proper steps to put on a sterile gown safely and review the necessary techniques to minimize contaminating your gown or the aseptic environment.

Self-guided

0.5 hours

Airflow

Learn about proper cleanroom design, managing airflow within the context of a cleanroom environment, and conducting smoke studies that verify proper airflow management. 

Self-guided

4 hours

Aseptic Process Simulations (Media Fills)

Enhance your understanding of the statutory and regulatory requirements and rationale for the design, performance, and evaluation of aseptic process simulations. Topics covered include why integral media-filled units must be incubated and evaluated, and the need to thoroughly investigate failures and implement corrective actions.

Self-guided

2 hours

Stability and Beyond Use Dates

Learn policies, procedures, and processes related to stability studies and beyond use dating (BUD) as they relate to outsourcing facilities. Topics of this course include regulatory requirements, technical aspects of establishing a stability program and BUDs, key concepts in designing a stability program, test requirements for stability testing methods and acceptance criteria, important aspects of testing compounded drug products, case studies, and special situations. 

Self-guided

4 hours

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Save-the-Date: December 14, 2022

What to Expect after an Inspection: 483s, Responses and Beyond

FDA will provide an overview of what to expect after an inspection and discuss the FDA Form 483, inspection closeout, post-inspection expectations and regulatory responses.


Presentations

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Presentation

Description

Event

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. 

2021 Compounding Quality Center of Excellence Annual Conference

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.

2021 Compounding Quality Center of Excellence Annual Conference

FDA Inspections of Outsourcing ORA

What to Expect on a 503B Inspection CDER 

The presentation covers the inspection processes and what facilities should expect during a 503B inspection, from initiation to completion.

2021 Compounding Quality Center of Excellence Annual Conference

ANDA 

FDA Approvals 

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. 

2021 Compounding Quality Center of Excellence Annual Conference

Analytical Testing

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. 

 

2021 Compounding Quality Center of Excellence Annual Conference

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.

2021 Compounding Quality Center of Excellence Annual Conference

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.

 

2021 Compounding Quality Center of Excellence Annual Conference

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.

 

2021 Compounding Quality Center of Excellence Annual Conference

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.

 

2021 Compounding Quality Center of Excellence Annual Conference

Stability BUDs 

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.

2021 Compounding Quality Center of Excellence Annual Conference

Future of OF Compounding 

FDA representatives discuss the future and identity of the outsourcing facility industry, and what panelists expect in the compounding world over the coming years.

2021 Compounding Quality Center of Excellence Annual Conference

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