Thursday May 9, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished product, it has become increasingly important for Companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of microbiology — regardless of the Department in which they work. Every individual within varying Departments from Facilities to Manufacturing to Quality Control should understand the basics of microbiology and the issues that non-compliance can create. Recently, a large multi-national pharmaceutical company was cited for the second time by the FDA for not determining that mold was growing on the “clean side” of the HEPA filters in an ISO Class 5 environment after it had been identified by mechanics several years previously.
In addition, a Form FDA 483 (January 2011) which was subsequently followed by an extensive recall (January 2011), a seizure and ultimately a Consent Decree for the Triad Group, Hartland, WI, a manufacturer of non-sterile and sterile alcohol prep pads, swabs, and swabsticks, illustrate the importance of having knowledgeable personnel regarding microbiological procedures within your manufacturing and laboratories facilities. This facility received multiple Observations for not providing its personnel with adequate microbiological training and ultimately closed.
The objective of this live, interactive Executive Conference Corp. webinar is to provide for the non-microbiologist an introduction and background to enable this individual to understand the basics of microbiology as well as provide to the microbiologist who may have moved on to other areas a refresher course which addresses selected issues and answers facing those that may have microbiological concerns within their facilities. Plan to bring a cross-functional group of your personnel to attend this invaluable seminar.
THE PRESENTATION WILL COVER
- Introduction to Industrial Microbiology
- Definitions Commonly Used in Microbiology
- Common Contaminants Based upon USP <60> and <62> and In-House Microorganisms
- Environmental Contamination and What it Means to You
- Cross Contamination within A Manufacturing Facility
- Environmental Testing and Associated Challenges
- Management of Your Environmental/Water Utility Systems
WHO WILL BENEFIT FROM THIS WEBINAR
- Facilities
- Manufacturing
- Quality Assurance
- Regulatory Compliance
- Quality Control
- Validation
- Metrology
- R & D
- Project Management
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-599