242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start
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 department? Audit CAPA across the organizat...
17 Kesä 12min
241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?
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 than reviewing the guideline sect...
10 Kesä 10min
240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy
ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances a...
3 Kesä 11min
239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes
In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.The core question behind ICH Q12 is simple: once a ...
27 Touko 10min
239 - ICH Q11 in 6 Minutes
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 places Q11 in context with...
20 Touko 6min
238 - 6 Audit Strategies Every Auditor Should Know
Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode,...
13 Touko 10min
237 - ICH Q10: The Pharmaceutical Quality System
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 is not a certifiable ISO-style...
6 Touko 8min
236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences
ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how i...
29 Huhti 12min
