Conference Description:

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation.

Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated.

Why You Should Attend:

Medical device regulations in the US and the EU are foundational to the remainder of the regulations that are applied to medical devices throughout the world. An inspection by a representative of a regulatory body or a complaint from the market could uncover regulatory violations that may result in sanctions of various levels of seriousness.

Areas Covered in the Session :
By attending this interactive session, you will learn:

>. FDA Regulations and Guidance on Sterility Failure Investigations
>. Stages of Investigation: Lab Investigation vs. Manufacturing Investigation
>. Tools to use to help determine Root Cause
>. How to categorize sterility results
>. How to address impact to lots affected
>. Areas, parameters and variables to investigate as part of the investigation
>. Proper documentation of the Investigation
>. CAPA plans that address root cause

Who Should Attend:

>. Quality Assurance Departments
>. Quality Control Departments
>. Manufacturing Departments
>. Facilities & Engineering Departments
>. Chemistry & Microbiology Departments