Thursday, March 15, 2018
1:30 pm – 3 pm EDT
Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)
Microbiology plays a role throughout the manufacture of pharmaceutical products. Whether the final product is non-sterile or sterile, the bioburden exists throughout the process and/or within the product’s environment. A critical review of the overall microbiological process will determine whether the critical “in-process” points permit the final product to meet its acceptance criteria. In addition, any “objectionable” or “specified” microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.
With cell culture derived products, an often neglected criteria which “shows up” in the final product specification is endotoxin. Many biotechnology and cell culture manufacturing facilities set extremely low final endotoxin specifications, not expecting to encounter any because the process should be devoid of it, and are suddenly surprised when the final product is out of specification because of the occurrence of endotoxin. What they forget is that they should have had an endotoxin specification within their raw material specification which was never thought of or neglected, and no one bothered to test for it.
Whether you are auditing a raw material supplier, a testing laboratory, or your own facilities, you should be aware of the critical role the microorganisms play throughout. You should be aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, to determine whether the vendors’ SOPs, cleaning and other validations as well as government and other regulatory body documents are maintaining the control required to permit the final product to enter the marketplace as a safe product.
The objective of this Executive Conference Corporation webinar is to explore the areas that a microbiological audit should challenge within your or your vendors’ facilities to assure that your own SOPs, governmental and regulatory guidances and regulations are being met.
By attending, you will learn:
- To understand the breath of microbiological auditing within a pharmaceutical environment
- How microbiology applies to an operation — even before any materials arrive
- Why a Microbiological Plan to include cleaning and other validations should be in place before manufacturing commences
- Why the presence of endotoxin needs to be considered from in-coming raw materials to the final product
- How Microbial Enumeration impacts all microbiological issues
- How the products manufactured within a pharmaceutical facility impacts the Quality Control hiring requirements
- The impact of the environment and utility systems upon a successful microbiological audit
- Laboratory aspects that should be included in a microbiological audit
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-013