Fundamentals of Sterile Pharmaceutical Dosage Forms Training Course

Gain knowledge of the basic principles of sterile pharmaceutical dosage forms required to effectively approach formulation design, process development, scale-up, validation, sterility assurance, and regulatory inspection preparation based on current inspection trends for parenteral manufacturing. This introductory two-day training course will address cleanroom design, environmental monitoring and control, sterilization principles, manufacturing unit operations, aseptic filling, dosage form development, primary packaging and stability requirements, validation of aseptic processing (media fills), product specific validation, QA/QC for parenterals, and regulatory trends. The training course will include relevant information as it applies to small molecules, biologics, antibody-drug conjugates (ADCs), vaccines, and cell/gene therapy (CGT) modalities.

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

1. Describe the basic principles of cleanroom facility design, environmental monitoring, and aseptic processing
2. Summarize the design and interpretation of media fills
3. Describe product specific validation for parenteral dosage forms
4. Describe fundamentals of dosage form development, packaging, and stability, and unique aspects for mRNA, CGT and other biologics
5. Describe the chemical composition of endotoxins, their toxic effects, sources, and testing procedures
6. Summarize the CGMP regulatory and inspection trends for parenteral manufacturing

For more options and/or related training courses, please visit the following page(s):

• PDA Biopharmaceuticals Training Courses