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Webinars

View a selection of webinars discussion the latest news and trends in Pharmaceutical Quality Control.

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Annex 1 and Environmental Monitoring Program

Annex 1 and Environmental Monitoring Program - Implementation And Justification of The Best Practices In Routine - What is new? How to implement the changes? - EM program and Contamination Control Strategy - Example of Risk Analysis Methodology - EM program and Data Management

From Challenge to Change: Implementing Digital and Automation Projects in Pharma

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.

Rapid Implementation of NAT technology for Mycoplasma with AnaBioTec & BIOFIRE Mycoplasma

Rapid Implementation of NAT technology for Mycoplasma with AnaBioTec & BIOFIRE® Mycoplasma

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.

Webinar - Molecular Innovation for Food Pathogen Testing

Next Generation mRNA Vaccine CQA Analytics

✅ Why analytical methods developed for traditional monovalent vaccines are a bottleneck for mRNA vaccine development and manufacturing ✅How InDevR utilizes decades of multiplexed assay development and manufacturing experience to accelerate mRNA vaccine development ✅ The ways InDevR continuously monitors and verifies assay kit performance for new strains ✅ How InDevR’s expert services team can develop custom off-the-shelf assays specific to your vaccine samples

Ultra-rapid microbial detection in cell & gene therapy products

Ultra-rapid Microbial Detection in Cell & Gene Therapy Products: the Closest you can be to Real-time Release

When innovators are focused on shortening manufacturing process to meet patient demand for life saving therapies, there is a need for new quality control analytical method solutions that are fast enough to keep pace with faster manufacturing approaches. This poster explores a new ultra-fast sterility solution for cell and gene therapeutic products.

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High Throughput Endotoxin Testing

Automate your endotoxin testing with bioMérieux's ENDOZYME® II GO on Tecans Fluent automated liquid handling workstation - no manual vortexing and no dilutions.

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Regulatory Submission Strategy for Implementation and Validation of a New PCR-Based Technology for Mycoplasma 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.

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1-hour mycoplasma testing

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.

Current Status and Overview of the Rapid Microbiological Methods and Endotoxin Microbiology USP Chapters under Development

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.

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Leveraging Instrumentation to Accelerate Release Testing & Minimize Human Input

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.

How to implement single temperature incubation in your EM routine?

Environmental Monitoring: Expert Discussion on the Benefits of a Single Incubation Temperature

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.

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BIOBALL^® 3-Part Webinar Series

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.

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Streamlined mRNA Vaccine Characterization with the VaxArray Platform

In this webinar, Dr. Lacey will showcase the utility of the VaxArray platform throughout mRNA vaccine development. He will specifically focus on off-the-shelf VaxArray assays including the recently released 5’ CapQ Assay for assessing mRNA integrity as well as the OmniFlu HA/NA Assay for multiplexed analysis of expressed influenza antigens. Additionally, he will highlight the essential role that Sino Biological plays in ensuring that InDevR has the most up-to-date and effective reagents for testing and updating VaxArray assays.

How can the latest regulatory advances in endotoxin testing support your green agenda?

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.

rFC: from scientific breakthrough to implementation

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.

Webinar Low Endotoxin Recovery

The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.

Validation and Implementation of a Novel, Nearly Fully Automated and Rapid PCR Based Technology Webinar

Regulatory Submission Strategy for Implementation and Validation of a New PCR-Based Technology for Mycoplasma 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.

Reliable and Sustainable Bacterial Endotoxin Testing Webinar

Reliable and Sustainable Bacterial Endotoxin Testing

This webinar will introduce the concept and relevance of bacterial endotoxin, along with a review of established detection methods. Dr Reich will discuss the emergence of recombinant Factor C (rFC) as a consistent and sustainable basis for endotoxin testing, the principles of its use, and performance of endotoxin tests based on rFC in comparison with tests based on limulus amoebocyte lysate (LAL).

503Bs Adopt Strategies to be FDA Audit-Ready Webinar

503Bs Adopt Strategies to be FDA Audit-Ready

Given the FDA’s growing scrutiny over 503B outsourcing facilities (503B) complying with regulatory requirements, many pharmacies are not only preparing for a potential impromptu visit from the FDA, but also building their company culture as an audit-ready organization.

Contamination Control Challenges Webinar

Contamination Control Challenges Facing Cell Therapy Facilities

The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one size fits all approach cannot be taken.

CBER's Perspective on Evaluation and Implementation of Rapid Microbial Methods Webinar

CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods

Listen to CAPT Simleen Kaur, Team Leader for Laboratory of Microbiology In-vivo Testing and Standards at FDA Center for Biologics and Evaluation and Research, and Lori Daane, Sr Director of Scientific Affairs at bioMérieux, discuss CBER’s current thinking concerning validation and implementation of rapid microbial methods.

Commercial Cell Therapy Webinar

Commercial Cell Therapy Experience Using Mycoplasma NAT for Product Release

Access the webinar to learn why rapid detection of mycoplasma is essential for product release testing of autologous cell therapy products such as MACI® (autologous cultured chondrocytes on porcine collagen membrane).

Value of the QC Testing in ATMP Webinar

Value of QC Testing in ATMP

Learn more about improving the time to result of QC testing with rapid and automated solutions, advance safety testing of ATMP from raw materials to product release, & bringing flow cytometry analysis to point-of-need

The Truth and Fallacies of Recombinant Endotoxin Assays Webinar

The Truth and Fallacies of Recombinant Endotoxin Assays

The comparability and equivalence of recombinant Factor C (rFC) to LAL has been proven with over 10 peer-reviewed studies by government and pharmaceutical facilities. Some articles and papers with limited scientific proof have been recently published, attempting to raise doubt with users and authorities regarding the use of these recombinant methods. Because science matters, we invite you to participate in this webinar series to take a look at the truths and fallacies of recombinant endotoxin assays. Our experts will be happy to answer your questions.

Overcoming LER Webinar

Overcoming LER

The phenomenon of low endotoxin recovery (LER) has gained renewed attention in the scientific community in recent years, as the FDA requires that all new BLAs are able to successfully unmask endotoxin if LER occurs. In this webinar, endotoxin experts demystify LER and discuss a “toolbox” for effective endotoxin detection.

Mycoplasma Testing Webinar

Mycoplasma Testing

For nearly 30 years, mycoplasma testing for biologics has been performed using cell culture-based methods. The compendial mycoplasma detection method has been the gold standard in the biopharma industry. Its high sensitivity (0.1 CFU/mL detection) is achieved through multiple subcultures and observations of culture media and agar plates over the course of 28 days.

Evolution of an Automated Rapid Microbial Testing Technology Webinar

Evolution of an Automated Rapid Microbial Testing Technology

Dr. Lori Daane will discuss the evolution of an automated rapid microbial detection technology to meet pharmaceutical industry needs, including how a specialized culture medium and temperature combination might optimize fungal detection.

Regulatory Strategies and Case Studies Webinar

Rapid Sterility Testing

Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients, and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.

The Effect of B-Glucans on LAL Activity Webinar

The Effect of Β-Glucans on LAL Activity in Pre-Treatment Water

The efficacy of recombinant Factor C (rFC) for bacterial endotoxin testing (BET) has been proven with multiple peer-reviewed papers comparing rFC with LAL. Non peer-reviewed data has been circulating looking at the Limulus amebocyte lysate (LAL) and rFC reactivity of pre-treatment deionized water.

Evaluation of Large Volume Delayed Sampling Webinar

Evaluation of Large Volume Delayed Sampling and Pathogen Reduction Technology Strategies

Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are two strategies for platelet processing to control risk of contamination prior to transfusion. LVDS and PRT have different processing methods, risks, and impact on platelet shelf life that can affect platelet costs and availability to the healthcare system.

Just in Time Release of CAR-T Cell Therapies During COVID-19 Webinar

Just in Time Release of CAR T-Cell Therapies During COVID-19

Listen to Irving Ford, Head of Quality at Adaptimmune*, and Lori Daane, Sr Director of Scientific Affairs at bioMérieux, discuss rapid microbial methods like the BACT/ALERT® and the BIOFIRE® Mycoplasma for testing short shelf-life products.

Beyond the Status Quo: Making the Case for Single Temperature Incubation

Explore the science, compliance considerations, and practical benefits of Single Temperature Incubation.

BACT/ALERT® 3D: From Alternative to Routine for Testing Cell and Gene Therapy 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!

On Demand: Mycoplasma Testing

The standard test for mycoplasma contamination is evolving. As macromolecule drugs derived from mammalian cells become more commonplace, reducing the turnaround time for testing has become essential for manufacturers to ensure productivity.

We are Going Back to the Future with Rapid Methods Webinar

We are Going Back to the Future With Rapid Methods

Rapid methods have been available to the pharmaceutical industry for decades. Although global regulations have changed to encourage their use (especially for rapid sterility testing) and the compendia have enhanced their chapters to promote the validation and implementation of these technologies, only a handful of firms have embraced rapid methods to their fullest potential.

True Cost of Quality in Pharma QC Webinar

How to Optimise Your EM Programme

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.

Endotoxin Testing With Sustainable rFC

Endotoxin Testing with Sustainable rFC: New Pharmacopoeia Developments and Implementation for Routine Use

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.