Bio/Pharmaceutical companies, and companies planning or currently building new facilities require a comprehensive cleaning program that includes, disinfection and environmental monitoring (EM). To comply with FDA 21CFR Part 210 & 211 or other regulations, these processes must be in a state of control. By establishing a rugged and reliable EM program (from EMPQ to routine sampling), the risk of a contamination event is less likely to occur. Product safety depends on the condition of your facility, as well as the team involved. Securing knowledgeable partners to plan and manage your EM program ensures a seamless and simplified process, building confidence that you are adequately prepared for regulatory body facility inspections.

When an EM sample shows growth, it’s critical to understand the impact on your operation. Once excursions are identified, they must then be investigated and appropriate actions taken to mitigate the issue. Demonstrating your facility’s cleaning program is effective by executing disinfectant efficacy studies is an essential part of the plan.

During this webinar, we will dive into:

Recent case studies that resulted in the issuance of 483 observations
Plan (EMPQ) - Do (Sample collection and analysis) - Study (DES, ID, Trend) - Act (On-going monitoring, CAPA, Change Control)
Implementation of rapid microbiological testing methods
Automation of data collection and analysis
Development of robust contamination control strategies
Data integrity and analysis
Continuous microbial monitoring

Presenters:

	Alexis Mathews Site Director Eurofins BioPharma Product Testing
Alexis Mathews, Site Director of Eurofins BioPharma Product Testing in Crown Point, IN, spent the last 10 years working from the bench to her current role, where she leads an efficient and knowledgeable team supporting vast microbiology testing, disinfectant efficacy studies, environmental monitoring, and aerosolization studies. Alexis’ passion is evident as she enjoys working with clients to develop robust protocols with microbiology support spanning the industry in medical device, bio/pharmaceutical, EMPQs, and regulatory response. Alexis and her team provide comprehensive partnership from start to finish, whether assisting with drug product development through commercialization or introducing a new facility. Alexis earned her Bachelor of Science from Indiana University Northwest.
	Diane Lockard Group Leader III Eurofins BioPharma Product Testing
Diane Lockard, Group Leader III with Eurofins BioPharma Product Testing, has over 30 years of experience in FDA regulated industries, including agriculture, food, dietary supplements, and bio/pharmaceutical. She expanded her experience by completing Microbiology courses at Brigham Young University. Much of her knowledge was acquired through hands-on laboratory work and various management roles. Her current role oversees Disinfectant Efficacy Testing.

Moderator:

	Josh Reyer Regional Sales Manager Eurofins BioPharma Product Testing
Josh Reyer is a Regional Sales Manager for Eurofins BioPharma Product Testing, and is based at the Lancaster, PA site. He earned his bachelor’s degree in biology from The Pennsylvania State University. He manages client relationships and projects in the Philadelphia and Delaware region, which he has been supporting since he joined Eurofins 3 years ago.

Event Overview

Biologic manufacturing processes inherently have the potential to become contaminated with a virus. Process inputs, downstream purification, and final substance/product have to be assessed for potential viral contaminations. A well-designed viral clearance study is a complementary part of the overall virus testing and safety strategy for biologics. These are custom for each product and process. This webinar will focus on the downstream purification process and the need to perform viral clearance studies to support the manufacture of biologics.

Presenter:

Name
Title
Eurofins BioPharma Product Testing

Moderator:

Name
Title
Eurofins BioPharma Product Testing

Homepage \| Search \| Careers \| Contact Us
Cookie Notice \| Web Privacy Notice \| Update Preferences		Copyright Eurofins USA © - All Rights Reserved