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A Journey through the Pharmaceutical Regulation and Quality Design

A Journey through the Pharmaceutical Regulation and Quality Design

FromQueens of Quality Podcast


A Journey through the Pharmaceutical Regulation and Quality Design

FromQueens of Quality Podcast

ratings:
Length:
24 minutes
Released:
Oct 24, 2023
Format:
Podcast episode

Description

Welcome to another episode of Queens of Quality. In this episode, we explore the key concepts of ICH (International Council on Harmonization), with a focus on the recent revisions to ICH E6R3 and ICH E8R1. These revisions bring significant changes to the pharmaceutical industry's regulatory landscape, emphasizing the importance of quality by design in clinical trials.Tune in!During this episode, you will learn about;0:00:49 - ICH Introduction0:02:13 - The Significance of ICH E6 and E80:04:41 - The Global Impact of ICH 0:08:02 - The Evolution of Technology0:11:30 - Quality by Design 0:18:51 - Operational Feasibility0:21:16 - Complementary Guidance            Love the show? Subscribe, Rate, Review, Like, and Share!Let’s Connect!Connect with Queens of Quality;Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com
Released:
Oct 24, 2023
Format:
Podcast episode

Titles in the series (19)

Quality and compliance are often seen as rigid within an organization. Every company has ‘em; nobody wants ‘em, but it’s even more imperative to implement them. Join, Michelleanne and Jen, host of Queens of Quality, the podcast, as they discuss topics in reasonable and, at times, light-hearted delivery. Receive insight on how these requirements can be implemented in a compliant, scale-able, and sustainable manner for organizations at any point within the company life cycle. Every week, we will provide solutions for day-to-day issues to debunk some of the misconceptions about Quality Assurance. Subscribe to the show to stay up to date with new episodes.