Tuesday April 16, 2019
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules have historically been minimal when compared to aseptic manufacturing. These rules have included the handling and evaluation of non-sterile components, the environment and final product, but not to the extent of sterile products.
This 90 minute Executive Conference Corp. (ECC) webinar discusses various regulations and requirements and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Water Activity, which was out of vogue until recently, will also be reviewed. The “Art of Troubleshooting, Finding What Occurred”, will also be highlighted.
Products that are sold as sterile, but include a non-sterile phase within their manufacturing cycle will be reviewed since the Regulators often have concerns regarding these in-process materials. Thoughts about in-house microorganisms that may be considered as “specified” vs. “objectionable” to include the B. cepacia Complex will also be discussed. Warning Letters, Recalls and USP Chapters will be used to highlight the various discussion points.
The objective of this live, interactive Executive Conference Corp. webinar is to explore the regulatory and USP interaction between microbiology and a non-sterile cGMP environment and how finished products may be released – even though they may contain microorganisms. Please plan to attend this with an interdisciplinary team to share this information.
By Participating in this Webinar, you will learn:
- Of the various Regulations pertaining to non-sterile raw materials, in-process materials and final product.
- Examine the various USP documents that discuss the elements associated with the concept of non-sterile manufacturing.
- Gather information regarding the impact of process hold times, preservation issues, cleaning, sanitization, and the requirements for the testing of recovered microorganism.
- Understand when recovered microorganisms require testing.
- Learn why Warning Letters and Recalls are issued for non-sterility.
Who Should Attend:
- Quality Assurance
- Quality Control
- Manufacturing
- Validation
- In-Coming Materials
- Project Managers
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-102