PDA Compounding Training Courses

Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounded drugs are not approved by FDA. Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. Drug compounding can be performed in pharmacies, hospitals, clinics, and healthcare facilities, or at outsourcing facilities which provide compounded drugs to healthcare facilities without receiving a patient-specific prescription.

PDA has a four-year collaboration with the U.S. Food and Drug Administration’s (FDA) Compounding Quality Center of Excellence, which aims to help outsourcing facilities improve the quality of compounded drugs for patients who need them. The training provided through this collaboration focuses on current good manufacturing practice (CGMP) requirements.

Training courses are offered as in-person and virtual instructor-led and self-guided online formats. All training courses offer continuing education (CE) credits for pharmacists, pharmacy technicians, physicians, and nurses.

Training Course Registration

Upon clicking on the training course links below, you will be directed to the Train.org website for more information about the training courses and registration. If you have a Train account, please log in and select a session for the training course(s) you request to attend. If you do not have a Train account, please register, and retain the username and password for future access.

All registrations for the instructor-led trainings are pending approval. You will receive updates via email on your registration status. There is limited space for these training courses and attendees will be prioritized utilizing the following criteria:

  • Operations, production and manufacturing personnel
  • Quality personnel, including quality control and quality assurance
  • Pharmacists
  • Facility and engineering personnel
  • Microbiologists
  • Laboratory personnel
  • Pharmacy technicians
  • Management
  • Senior leadership

It is recommended that participants book their travel for in-person training courses after receiving their approval email for the training course. Please contact [email protected] with questions.

Instructor-led training courses are only intended for U.S.-based participants. However, the self-guided online training courses are available to everyone.

In-Person, Instructor-Led Training

These training courses are primarily held at PDA’s Training and Research Institute in Bethesda, MD. You will learn how to better address specific aspects of drug compounding quality with case studies and hands-on activities designed for real-world applications. Training courses run for two to three days depending on the training course content.

PDA 868 Sterile Drug Compounding for Outsourcing Facilities
Learn the basic principles, processes, and systems related to sterile drug production. The training course integrates principles of aseptic processing, sterile filtration, cleanroom operations, facility cleaning and disinfection, aseptic process simulation (media fills), and environmental monitoring – all within the context of regulatory expectations.

PDA 870 Environmental Monitoring for Outsourcing Facilities
Learn how to develop an environmental monitoring program and various sample collection methods through a combined teaching approach of lecture and practical activities.

PDA 898 Cleanroom for Outsourcing Facilities
Learn through practical activities to highlight cleanroom performance tests such as airflow velocity and uniformity, high-efficiency particulate air (HEPA) filter leak testing and repairs and airflow visualization smoke studies.

Virtual, Instructor-Led Training

These training courses provide the opportunity to interact with your instructor to learn more about current good manufacturing practice (CGMP) requirements as they pertain to pharmaceutical compounding, ask real-time questions, and engage with others from across the compounding community. Training courses are conducted on four consecutive half-days.

PDA 869 Investigations & CAPA for Outsourcing Facilities
Learn science-based methodology integrating problem solving techniques from total quality management (TQM), Six Sigma, Kaizen, and other techniques to identify the technical root causes, systemic root causes, corrective and/or preventive actions, and a control plan for preventing recurrence.

PDA 873 Process Validation for Outsourcing Facilities
Learn 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 introductory training course aligns process validation activities with a product lifecycle concept and existing FDA guidance documents for the industry, including Process Validation: General Principles and Practices and the following FDA/International Council on Harmonisation (ICH) guidelines: Q8(R2), Pharmaceutical Development; Q9, Quality Risk Management; and Q10, Pharmaceutical Quality System, all developed to ensure product quality.

PDA 874 Quality Management System for Outsourcing Facilities
Learn the fundamentals of establishing an effective quality management system (QMS) and building a culture of quality within a facility. This training course includes information about the comprehensive QMS approach to quality, the critical role of senior leadership, and building a quality culture mindset throughout the organization. The training course will also explore the concepts of knowledge management, quality risk management, and data integrity. Practical activities will include the use of case studies, responding to inspectional observations and warning letters, conducting quality culture assessments, and evaluating data integrity risks.

Online, Self-Guided Training

These training courses provide an overview of select CGMP requirements and compounding policy topics. Modular self-guided training courses are available to everyone on demand.

PDA 840 Airflow
Learn about proper cleanroom design, managing airflow within the context of a cleanroom environment, and conducting smoke studies that verify proper airflow management.

PDA 841 Insanitary Conditions and Sterility Assurance
Learn how to improve sterility assurance and prevent insanitary conditions to protect patient health. This training 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 identifying, mitigating, and correcting insanitary conditions.

PDA 842 Investigations & Corrective and Preventive Action (CAPA)
Learn how to conduct investigations and formulate corrective and preventive actions (CAPA). Discover elements that trigger investigations, investigative tools, developing and implementing CAPA, verifying effectiveness of CAPA and initiating and completing investigations and CAPA.

PDA 843 Outsourcing Facility Guide
Learn important regulatory information about the requirements specific to outsourcing facilities. Discover practical information for outsourcing facilities 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.

PDA 844 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 the FDA inspection process and compounding oversight, including Form FDA 483s, warning letters, and regulatory meetings.

PDA 845 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 training course include regulatory requirements, the technical aspects of establishing a stability program and BUDs, key concepts in designing a stability program, the test requirements for stability testing methods and acceptance criteria, important aspects of testing compounded drug products, and case studies and special situations.

PDA 871 Aseptic Process Simulations (Media Fills)
Learn about the requirements and rationale needed to design, perform, and evaluate FDA compliant aseptic process simulation (APS) studies. The training course includes textual descriptions, examples with knowledge check questions, graphics, references, and voice overs where such additional emphasis may be of value.

PDA 875 Supplier/Contractor Qualification & Management
Learn how to select, qualify, manage, and audit suppliers / contractors from which an outsourcing facility is acquiring services and supplies. This training course will describe 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.

PDA 876 Personnel Gowning in Sterile Drug Production
Learn the proper procedures for personnel gowning in sterile drug production through interactive elements, video instruction, and knowledge checks.

PDA 877 Sterility Testing: Common Misconceptions
Learn critical aspects 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.

Funding for this training was made possible, in part, by the Food and Drug Administration through grant (1UE5FD008142). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the U.S. government.