Overview
Welcome to BioNetwork’s second training course for freeze drying. In the next 20 minutes, we’ll examine important FDA regulations related to freeze drying. We’ll learn how to design a successful process, and examine ways to prove our equipment and products meet the highest quality standards.
Objectives
Upon completion of this course, you'll be able to:
- Explain FDA regulations and guidelines that apply to the lyophilization of pharmaceutical products.
- Describe the principles of process validation and its application in verifying the reliability of the lyophilization process.
- Define the elements of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Understand how to perform and validate freeze dryer cleaning and sterilization.
eLearning Series
This eLearning module may be associated with more than one Series. Visit or return to an eLearning Series below.
