Let's Combinate - Drugs + Devices8 Des 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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Episoder(257)

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualific...

12 Aug 11min

249 - The Best Audit Advice Nobody Told Me

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may n...

5 Aug 14min

248 - What Is a Quality Unit? QA vs. QC Explained

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, m...

29 Jul 8min

247 - Why Everyone in Pharma and MedTech Should Work in Quality

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of ho...

22 Jul 8min

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Most discussions about One QMS focus on harmonization.But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organ...

15 Jul 8min

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and ...

8 Jul 45min

244 - 5 Critical Quality Differences Between Drugs and Devices

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same an...

1 Jul 8min

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-sessionFinished medical devices can create a lot of surprises when they are added to combination product kits.A needle, vial a...

24 Jun 14min