Faculty: Kenneth Christie
The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents that address other issues such as closure integrity and sterility test methods that were recently revised.
Today, the regulatory requirements for sterile products are found in a “Guidance for Industry” document that was published in 2004. In addition, there are requirements found in 21 CFR 210-211 and 820. In all of these documents, the areas of importance and audit focus are:
This webinar will discuss the most important issues that apply to sterile products in order to provide an overview for attendees to evaluate their own processes and procedures. It will not go into detail on the various sterilization methods that are used within the industry, nor will it detail how best to establish process simulations. Recent 483 observations will be reviewed to help highlight common industry deficiencies and as a reference to compare attendees current practices.
Areas Covered in the Session :
Who Should Attend: