Let's Combinate - Drugs + Devices20 Loka 2021

003 - “Standard Understanding” with Mark Swanson

In this episode I sit down with Mark Swanson. We discuss Mark’s background and early career, his entrance into QA, his participation on standard work groups for ISO13485 and ISO9001, the standards process and more. Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and a Principal Consultant of Quality and Regulatory Expert Partners (QRx Partners); a partnership consulting firm focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI committees) and a RAPS member. Mark has spent several years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) that published the revision of ISO 13485 in 2016 and was the project co-lead for the guidebook on ISO 13485. Mark is the chair of AAMI mirror committee for WG6 on post-market surveillance, member of the US mirror committee for JWG1 for ISO 14971/TR 24971 and has also participated with ISO TC176, on ISO 9000:2015 & ISO 9001:2015 as well as IWA31 on the application of risk management. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.

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Jaksot(245)

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

235 - ICH Q8: How Pharmaceutical Development Actually Works

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.ICH Q8 defines...

22 Huhti 10min

234 - ICH Q7: The GMP Framework for API Manufacturing

In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read ...

15 Huhti 13min

233 - Most Teams Misunderstand Specifications | ICH Q6

ICH Q6 Explained: Specifications, Control Strategy, and What’s Changing in Q6(R1)In this episode of Let’s ComBinate, Subhi continues the ICH Q-series with ICH Q6 and explains why specifications are ce...

8 Huhti 6min

232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to...

1 Huhti 34min