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
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