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Sterilization of Pharmaceutical Products and Medical Devices
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This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
- Types of sterilization methods.
- Predominant uses of sterilization within the Medical Device and Pharmaceutical/Biotech industries.
- Product interactions with Various Modes of Sterilization.
- When to Use one Sterilization Mode vs. Another.
- Parametric Release – What is it?
- How to Use Parametric Methods
- Development of the Techniques – Issues and Answers.
- Considerations of cost of sterilization.
- Use of contract sterilization vs. in-house.
- Manufacturing companies
- Quality system auditors
- Microbiology analysts and technicians
- Regulatory and Compliance Management
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Auditing Professionals
- Microbiology Professionals
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California.
(Contact us : 844-267-7299 | 954-947-5671
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