Let's Combinate - Drugs + Devices8 Dec 2021

010 - "Don't Make Assumptions" with David Simoens

On this episode of the Combinate Podcast, we had David Simoens, COO at cGMP Consulting Group. David and I discuss his career, and dive deep into commissioning, qualification, and validation. David outlines the activities in including discussing URS, DQ, FAT/SAT, IQ, OQ and PQ. David outlines the a risk based approach for streamlining commissioning and qualification activities, highlights some important things to watch out for and also gives some great book recommendations!

David Simoens is a certified Project Management Professional with over 7 years of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radio-pharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. Currently, David is supporting NPI launches for a large pharmaceutical company and operating a 100 person consulting company across multiple clients.

Founded in 2001, cGMP Consulting Inc. has strived to help our clients adopt new technologies and ensure that changes to your processes are compliant with current Good Manufacturing Practices (cGMP). Our experienced engineering and quality assurance consultants have helped many industry leading companies identify and remediate gaps, support international pharmaceutical manufacturing, and implement cGMP requirements.

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Avsnitt(247)

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

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3 Juni 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 Maj 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 Maj 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 Maj 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 Maj 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 Apr 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 Apr 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 Apr 13min