This new course is designed to teach students the techniques for effective qualification and validation of sterile drug product manufacturing systems. It will use a combination of lecture and hands-on application at the PDA Training and Research Institute and will make extensive use of the Aseptic Processing Suite. Instructors will walk students through the planning, protocol development, execution, and troubleshooting of the qualification of various drug product manufacturing systems, including critical utilities, formulation/compounding, component parts sterilization, filling, and packaging. Lectures and case studies will provide the student the regulatory expectations, industry trends, and best practices for qualification and validation of sterile drug product manufacturing systems utilizing modern risk and science-based decision making approaches.

If you are involved with the planning, documentation, execution, or review of sterile drug product manufacturing system qualification and validation for capital projects or on-going facility operation and remediation, this hands-on course will provide essential knowledge and training in the approaches needed to successfully perform those functions.

Upon the completion of this course, you will be able to:

• Identify the aspects of sterile drug product manufacturing which effect product quality and require qualification and validation
• Discuss the types of and reason for approaches to sterile drug product manufacturing qualification and validation
• Describe the appropriate methodology for making risk and science-based decisions related to the planning and execution of qualification and validation of sterile drug product manufacturing systems
• Explain and demonstrate the best practices for sterile drug product manufacturing system qualification and validation

Walter Henkels, Concordia Valsource
Phil DeSantis

PDA #457 | ACPE #0116-0000-12-457-L04-P | 2.4 CEUs
Type of Activity: Application