Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2 In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same and highlights five

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-session Finished medical devices can create a lot of surprises when they are added to combination product kits. A needle, vial adapter, filter, or transfer device may

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one

In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework. Rather

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances and drug products.Learn more:https://www.letscombinate.comSchedule a call:https://calendly.com/letscombinate/let-s-combinate-intro-sessionIn

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled. He

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery   Course Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-course   In this episode, Subhi explains why selecting the right auditing strategy matters when

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10