Thursday August 30, 2018
12:00 pm – 1:30 pm EDT
Instructor: Danielle DeLucy, MS
Overview:
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, the environment and the like. 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. The role of QC Microbiology in the identification and investigation of various results from manufacturing areas and finished product testing is extremely important.
When the need for an investigation arises, it is common for a cross functional team to convene involving all levels of management from various departments:
- Quality Control Chemistry & Microbiology
- Manufacturing
- Quality Assurance
- Facilities & Engineering
Why should one attend this webinar?
This course will describe the actions that should be taken when a sterility test failure occurs. What happens when a suspect microbial result is reported? What does it look like, how do you react? This webinar will review when it is appropriate to investigate a result that may seem out of the ordinary.
Areas Covered in the session?
- 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 will benefit by this webinar:
- QA and Manufacturing staff and management
- QC Lab personnel
- Microbiologists
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-044