PDA Compounding Training Courses

In-Person, Instructor-Led Training

These training courses are held at PDA’s Training and Research Institute in Bethesda, MD; Apella by Alexandria in Durham, NC; Open Biopharma Research and Training Institute, Carlsbad, CA; and Biomanufacturing Training and Education Center (BTEC), Raleigh, NC. 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.

Sterile Drug Compounding for Outsourcing Facilitites Training Course
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.

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

Cleanroom for Outsourcing Facilities Training Course
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.

Visual Inspection for Outsourcing Facilities Training Course
Learn the basic principles, processes, and systems related to visual inspection of compounded drug products through a combined teaching approach of lecture, group collaboration, and practical activities including regulatory requirements, manual and automated visual inspection of product, defect classification strategies, training/qualification, and inspection processes and challenges.

Quality Management Systems for Outsourcing Facilities Training Course
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.

Data Integrity for Outsourcing Facilities Training Course
Learn key concepts to consider when designing processes that collect and utilize data and associated metadata. The overall goal is to ensure data is complete, consistent, and accurate through consideration and control of sources of variability stemming from hardware, software, personnel and documentation. The training course combines lecture, discussion, small group breakout exercises, and case studies to evaluate the current regulatory expectations and best practices for data integrity, with an overall focus on safety of the patient through good scientific process design principles.

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.

Investigations and CAPA for Outsourcing Facilities Training Course
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.

Process Validation for Outsourcing Facilities Training Course
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.

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.

Airflow Self-Guided Training Course
Learn about proper cleanroom design, managing airflow within the context of a cleanroom environment, and conducting smoke studies that verify proper airflow management.

Insanitary Conditions and Sterility Assurance Self-Guided Training Course
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.

Investigations and Corrective and Preventive Action (CAPA) Self-Guided Training Course
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.

Outsourcing Facility Guide Self-Guided Training Course
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.

Regulatory Framework for Human Drug Compounding Self-Guided Training Course
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.

Stability and Beyond Use Dates Self-Guided Training Course
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.

Aseptic Process Simulations (Media Fills) Self-Guided Training Course
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.

Supplier/Contractor Qualification and Management Self-Guided Training Course
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.

Personnel Gowning in Sterile Drug Production Self-Guided Training Course
Learn the proper procedures for personnel gowning in sterile drug production through interactive elements, video instruction, and knowledge checks.

Sterility Testing: Common Misconceptions Self-Guided Training Course
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.