Amanda McFarland

Nov 17, 2023 | bioprocessonline.com | Amanda McFarland |Ryan Murray |Kate Hammeke |Eugenia Petoukhov

What if you could achieve intensified perfusion processes with high cell densities in just 2 mL, saving you precious media and associated costs? With the Mobius® Breez microbioreactor, you can rapidly collect high-quality data sets by running multiple cell culture experiments simultaneously and independently on your benchtop with only 2 mL working volume. Find out how. This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023.

Nov 16, 2023 | biosimilardevelopment.com | Amanda McFarland |Ryan Murray |Peter Alexander |Phillip Ramsey

This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like. The principles of an effective technology transfer can apply at every stage of the drug development life cycle for biotech companies of every size.

Oct 13, 2023 | outsourcedpharma.com | Louis Garguilo |Ryan Murray |Amanda McFarland

Things are moving relatively quickly at NervGen, but CEO Michael Kelly took time to speak about his outsourcing experiences and best practices for "hiring" external partners such as CDMOs.Risk Tool Selection With ICH Q9(R1) In MindThis article focuses on the ‘formality’ concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023.

Sep 19, 2023 | outsourcedpharma.com | Amanda McFarland |Ryan Murray |Louis Garguilo

By Amanda McFarland and Ryan Murray, ValSource, Inc. In January 2023, ICH Q9 Quality Risk Management1 was revised for the first time since its debut in 2005. In the revision, topics like subjectivity, product availability, risk-based decision making, hazard identification and risk assessment formality were elaborated upon. This article will focus on the formality concept.

Jun 2, 2023 | pharmtech.com | James L. Vesper |Amanda McFarland

As mentioned earlier, practitioners of QRM and leadership have an interest in determining if the outcomes of QRM are successful in their organizations as well as finding ways of improving the execution of a risk assessment and ensuring that subjectivity is minimized. Making simple modifications to the Kirkpatrick model and applying those to the risk-management lifecycle is discussed as follows.