The experts Marie Jorna Bled (Test & Release Excellence Lead Director, MSD) and Alicia Ruiz Mahillo (Group Quality Microbiology Manager, COMPASS by FAMAR ) joined by Arnaud PARIS - Pharma Quality Control (Business Director, bioMérieux Pharma Quality Control) dive into the journey of implementing change, from identifying impactful problems to building a business case and convincing stakeholders.
In this insightful webinar, you'll learn how rapid Nucleic Acid Amplification Techniques (NAATs), such as BIOFIRE ® Mycoplasma, can be seamlessly implemented as an alternative method for Mycoplasma detection in pharmaceutical production.
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
In this 15-minute webinar you will learn how you can maximize operational efficiency and save costs with 1-hour mycoplasma results using the BIOFIRE® Mycoplasma system.
An Overview of Recent USP Bacterial Endotoxins Standards Development.
Detection of bacterial endotoxins is a critical quality attribute of parenteral pharmaceuticals and medical devices. Bacterial endotoxins are cell wall components of Gram-negative bacteria, ubiquitous in nature, difficult to destroy and can cause pyrogenic responses or worse.
Don't miss this webinar with our partners, the National Institute for Bioprocess Research and Training (NIBRT). This session focus on quality control (QC) microbiology in the different types of advanced therapy medicinal products (ATMP) manufacturing.
This talk will focus on the analytical testing needed for the release of cell and gene therapy products. A lot of focus has been on improvements and automation of equipment used in manufacturing of cell therapies such as bioreactors. However, to improve and speed up the release testing, this needs to be done also on the analytical side.
The Environmental Monitoring program (EM) is an important quality control for the pharmaceutical manufacturing operations. The most common usage is doing sequential incubation time and temperature to maximize the range of recovery of the flora. The current practice is to start with the lower temperature (22,5°) to enhance the growth of environmental strains such as molds and to switch to the higher temperature (32,5°C) to recover human skin microorganisms.
In this three-part webinar series, you’ll learn about BIOBALL® from industry experts Dr. Megha Bajaj and Dr. Tony Cundell. Discover BIOBALL® best practices, applications in non-sterile product testing methods, our in-house Isolate service, and more.
This webinar delves into the ground-breaking developments in synthetic Bacterial Endotoxin Test (BET) methods, as well as the implications of the new USP Chapter <86> for Endotoxin Testing.
The detection of Bacterial Endotoxins in parenteral pharmaceuticals and medical devices is critical to patient safety and has traditionally relied on the Limulus Amebocyte Lysate (LAL) method. However, with the introduction of recombinant Factor C (rFC) and the adoption of USP Chapter <86>, the industry is taking a major step towards reducing the reliance on animal-derived materials while simplifying and modernizing endotoxin testing.
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
This webinar explores rapid sterility testing in Cell and Gene therapy, covering the pivotal role of rapid testing and evolving regulations. Discover why the BACT/ALERT® is the trusted choice for microbial contamination testing and optimize your processes for enhanced quality control and compliance!
This webinar, featuring expert insights from Genevieve Greene, James Flynn, from NIBRT, and Florian Morillon, from bioMérieux, explores the evolving landscape of Environmental Monitoring and quality practices within the pharmaceutical industry.
Explore the future of endotoxin testing at your convenience with our on-demand webinar replay. Learn how recombinant Factor C (rFC) technology is transforming quality control practices in the pharmaceutical and medical device industries.
