Sterilization processes are a critical component in the manufacture of sterile drug products and medical devices. These processes are used to ensure that products are free of microbial contamination and play a crucial role in delivering safe and quality healthcare products for patients. Sterilization of products or components is achieved through a variety of methods.
This webinar by expert speaker Kenneth Christie will review the basic FDA expectations for the most common forms of sterilization. It will review typical variables that need to be controlled for each process and address common deficiencies cited by the FDA for each. The session will weigh the pros and cons for each method and provide common expectations on how to qualify these various methods.
You will get a general oversight as to what each method involves cover and learn about some general sterilization terminologies that are important to be familiar with. In addition, this webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide and the critical parameters for each of the methods. It will highlight recent deficiencies cited by the FDA regarding sterilization methods and their validation.
This is a good basic course for those getting involved with performing and understanding sterilization cycles without going in to the details of determining sterility assurance levels.
Who should attend?
Those who are associated with:
- Dr. David Lim
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities,...
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