BioMonitoring Lunch & Learn Seminars are a convenient and enjoyable way for busy QC professionals and personnel responsible for microbiological monitoring in the pharmaceutical industry to stay on top of regulatory and technological advancements.
We will come to your site and provide lunch for all attendees along with in-depth technical presentations. You simply choose any 40 – 60 minute options from the following à la carte menu to customize a Lunch & Learn session specifically for your requirements. If you have room for dessert, you can opt for a 90-minute hands-on session customized by our experts to meet your specific product or application needs.
We offer a range of products and services for bioburden testing, sterility testing and other microbial quality control tests. Many of these products are manufactured according to the same guidelines used in manufacturing pharmaceuticals, including ISO® and GMP regulations.
At Lunch & Learn Seminars, our in-house experts will provide timely information on changing regulations and the latest test methods that affect our jobs.
Note: If this service is not available for your country of choice, please contact your local Millipore Application Specialist or call toll free 1-800-Millipore.
Choose one or two selections:
Session 40 – 60 minutes.
- Rapid Microbiology
Learn the benefits of implementing rapid microbiology for monitoring microbial contamination in raw materials, in-process materials and non-sterile finished products at your facility. The technology and applications of the Milliflex® Rapid Microbiology Detection System will be highlighted. The presentation will also discuss how to evaluate different rapid microbiological methods and develop your own user requirement specification (URS).
- Microbial Limits Testing
Take a look at current British, European and US Pharmacopeia requirements and potential updates or changes. The impact of microbial contamination on drug production will be discussed along with the various test methodologies available today for microbial limits. Discussion will include validation requirements and how to perform microbial limits tests.
- Sterility Testing
Review current sterility testing regulations and guidelines, industry issues and applicable future regulatory changes. Our experts will present an overview of a range of sterility test methods and lead a discussion on the critical aspects of sterility test components, highlighting a basic review of validation requirements. Practical solutions and helpful tips will be offered, based on decades of experience in sterility testing.
- Mycoplasma Testing
Our experts will review the new USP <63> for Mycoplasma to help you understand how this chapter will be enforced. Review of the Ph. Eur. 2.6.7 Nucleic Acid section will also be conducted as an alternative method for mycoplasma detection. They will also go through a brief demonstration of our MilliPROBE System for detecting mycoplasma.
- Aseptic Process Simulations - The Media Fill
Our experts will review the regulations and guidance for compliance with Manufacturing and Quality Control, which will demonstrate the guaranteed sterility of your product, personnel and procedures. We will discuss the design of a media fill and the impact that a positive result can have on your company. We will also present the benefits of granulated dehydrated culture media.
- Monitoring the Quality of Water
Update your knowledge of USP and EP regulations regarding water testing, focusing on FDA inspector guidelines for water. The range of water testing methodologies and their applicability to your applications will be examined. Our experts will highlight the critical components to consider when validating a water system and how to troubleshoot typical challenges involved in water testing.
- Understanding ISO 11133 and the Health & Safety Risks of Dehydrated Culture Media
Learn the crucial and extensive process of compliance with ISO 11133 for QC testing of microbiological media, which can minimize your risk of low performing media. Our experts will also review the health and safety risks of any dehydrated culture media to help ensure that your operators are not only safe but able to continuously produce media of high quality.
- Environmental Monitoring
Review the regulations and guidelines for microbiological monitoring of air. Air monitoring is a critical component of the environmental monitoring program of any pharmaceutical, biotherapeutic or medical device manufacturer as well as a Good Manufacturing Practice (GMP) requirement for both the US and Europe. The key aspects of an environmental monitoring program will be highlighted along with the distinguishing features of various methodologies and validation requirements.
- Selecting the Right Membrane Filter
Acquire the knowledge to select the right membrane filter for the particular characteristics of your product or application. Filter experts will discuss differences between filter matrices, the importance of pore size and the compatibility considerations inherent to specific membranes. They will also demonstrate how a filter works and explain which filters are ideally suited to particular applications.
- USP <797> Overview
As an overview of USP <797>, Pharmaceutical Compounding – Sterile Preparations, you will learn more about the many quality tests that are crucial to preventing contamination for all compounded products regardless of the “risk” level. You will learn more about the risk levels of compounding, antimicrobial effectiveness testing, sterility testing, biological indicators, endotoxin testing, media fill, and environmental monitoring of compounding environments which are measures that can help your compounding facility minimize the risk of contamination.
Click here to schedule a seminar in the US or Canada
If you cannot find a selection to meet your tastes, feel free to suggest a topic. To add a 90-minute hands-on session, please contact your local Millipore Application Specialist or call toll free 1-800-Millipore.