This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
Pharmaceutical products and medical devices are required to be sterile to be used in patients. Sterilization of these crucial products can be done in several ways depending on the characteristics of the product being sterilized. There are four typical ways a product can be sterilized. These are sterilization by Ethylene Oxide, Gamma irradiation, Steam and Pressure, and filtration. Knowing the characteristics of your product will determine what method will be used. This webinar will go over the four methods of sterilization and why one method would be chosen over the other.
Areas Covered in the Webinar:
Carl PattersonQA Team Lead, Bachem
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.
To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector.
Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.
Medical devices and Pharmaceutical products are used by patients who may be compromised in terms of developing an infection if an opportunistic microorganism is introduced into the patient’s body. Sterilizing pharmaceutical products and medical devices prevents this from occurring, by using various methods (heat, pressure, radiation, etc.) to destroy the microorganisms. In order for a medical device or pharmaceutical product to be approved there must be an assurance of its sterility.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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