Let's Combinate - Drugs + Devices

This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings.

Access the full CQA course here: https://cqeacademy.teachable.com/p/the-cqa-master-class-course

I break down key terms like finding, nonconformity, observation, and noncompliance, and explains that everything must tie back to requirements and objective evidence. The episode covers when to write a nonconformity vs an observation, common severity levels (critical, major, minor), and how to structure clear findings. I also cover how to sequence audit results and where auditors often go wrong, especially when they insert opinion or recommend solutions.

Timestamps
00:00 Course preview
00:42 Key audit terms
01:56 What makes findings reportable
04:16 Severity classification
06:42 Writing findings
07:57 Structuring reports
10:38 Auditor boundaries

Subhi Saadeh is a certified ISO 13485 Lead Auditor, CQE, and CQA with experience leading audits and building quality systems across medical devices and combination products at companies like Baxter, Pfizer, and Gilead Sciences. Through Let’s ComBinate, he focuses on bridging the gap between pharma and devices through educational content, industry collaboration, and consulting.

In this episode of Let’s ComBinate, Subhi Saadeh sits down with Joseph Luminiello, CEO and Co-Founder of RCG Intel, to break down how competitive intelligence is actually used in biopharma and why most companies get it wrong.

Joe introduces a practical framework built on three pillars: data (scientific publications and congresses), signal intelligence (press releases and filings), and human intelligence, which provides the context needed to interpret what those signals actually mean. While data and AI tools are becoming more accessible, Joe explains why interpretation and real-world insight remain the true differentiators in strategic decision-making.

The conversation covers real-world applications across pharma strategy, including evaluating low-cost API suppliers, make-versus-buy decisions, competitor assessments, and forecasting. Subhi and Joe also discuss how cultural incentives and assumptions often shape forecasts more than data, and why even well-built models can miss significantly.

Timestamps
00:00 Introduction
00:51 What is competitive intelligence
02:57 Human intelligence in practice
05:37 How insights are sourced
07:59 Validating and triangulating data
12:37 Forecasting and key assumptions
18:01 Common client blind spots
20:31 Speed of change in pharma
23:56 Why context matters more than raw data
27:27 Tools, congress strategy, and wrap-up

Links

RCG Intel:
https://rcgintel.com/
Joseph Luminiello on LinkedIn:
https://www.linkedin.com/in/joeluminiello/

Joseph Luminiello is the CEO and Co-Founder of RCG Intel, a boutique competitive intelligence consultancy serving the pharmaceutical and biotech sector. With more than 40 years of experience across healthcare, biopharma, and strategic intelligence, Joe has built his career around what he calls prescience, the ability to synthesize disparate data points and anticipate how they will shape the future. Before launching RCG Intel, Joe served as CEO of multiple biopharma companies, including AVM Biotechnology and Third Coast Therapeutics, where he raised capital and advanced drug development programs. As Founder and CEO of SmartHealth Catalyzer, he built a 150-member senior executive operations team and sourced over 130 intellectual property projects from Midwest universities. Earlier in his career, he spent six years at Takeda Pharmaceuticals, where he rose to Vice President of Business Development, contributed to diligence for Takeda’s acquisition of Nycomed, and helped launch Takeda Canada as its second employee.

Subhi Saadeh is the Founder and Principal at Let’s ComBinate BioWorks. He is a Certified Quality Auditor and ISO 13485 Certified Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences. Subhi has extensive experience across drug-device combination products, including supplier quality, development quality, design controls, purchasing controls, audits, and management of contract manufacturers and external partners. Through Let’s Combinate, he is focused on bridging the gap between pharma and devices by creating educational content, participating in industry groups, and providing consulting support to align development, quality, and regulatory expectations.

In this episode of Let’s Combinate, Subhi Saadeh speaks with Jen Riter about analytical method validation for drug device combination products. The discussion explores how traditional drug analytical validation under ICH Q2 differs from validating functional and mechanical performance methods used for combination products. These methods often require an engineering mindset that incorporates measurement system analysis (MSA), gage R&R studies, and the use of fabricated surrogate standards when devices cannot be reused for testing.

They also discuss platform test methods and how standards such as ISO 11040 and other ISO references can serve as starting points for method development. The conversation touches on the evolving alignment between ISO based device methods and pharmacopeial expectations such as USP <382>. The episode also covers make vs buy testing decisions, when to outsource specialized testing such as CCIT and extractables and leachables, and how sponsors manage oversight of contract testing laboratories.

Timestamps
00:00 Welcome and Guest Introduction
00:53 ICH Q2 vs MSA Mindset Shift
04:37 Surrogate Standards for Mechanical Testing
11:12 Platform Methods and ISO 11040
15:14 ISO vs USP Verification Debate
20:06 Outsourcing Analytical Testing Strategy
24:07 Choosing the Right Test Lab
26:20 Sponsor Oversight of Contract Labs
30:09 Wrap Up

About Jen Riter
Jen Riter is an analytical testing and laboratory leader with nearly three decades of experience working in pharmaceutical packaging, drug delivery systems, and combination products. She has held leadership roles at West Pharmaceutical Services and Kindeva Drug Delivery, where her work has focused on analytical method development, validation, and testing strategies for drug delivery systems and injectable combination products. She is also a contributor to the Combination Products Handbook, where she authored a chapter on analytical testing and method validation for combination products.

About Subhi Saadeh
Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks, where he helps companies close the gaps between drug and device development, quality systems, and regulatory expectations. He is a Certified Quality Auditor and ISO 13485 Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences including responsibility for management and oversight of assemble label pack sites and working with device primary, secondary and tertiary packaging suppliers. Subhi previously chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition, and served on AAMI’s Combination Products Committee. He also hosts the Let’s Combinate podcast and is a writer and speaker on quality at the intersection of drugs and devices.

Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where products cannot be fully characterized by physical and chemical testing alone and show inherent variability. It harmonizes expectations for viral safety, cell substrate controls including master and working cell banks, stability, and comparability after manufacturing changes. For combination products, Q5 mainly applies to the biologic drug constituent through stability and change impact rather than device requirements.

00:00 Intro to ICH Q5
00:25 Meet the Host
00:32 Why Biologics Need Q5
00:56 Key Risks Explained
02:11 What Q5 Covers
02:40 Scope and Structure
03:19 Q5 A to E Breakdown
04:19 How to Read Q5
05:05 Q5 for Combination Products
05:59 Wrap Up and Next Episode

Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.

Timestamps
00:00 Welcome and Guest Intro
00:53 The Hairiest CAPA Case
03:02 Human Error Root Cause
04:58 Common CAPA Misconceptions
06:11 Why Root Cause Fails
12:16 When to Open CAPA
17:26 CAPA Inputs and Triggers
19:28 One Process or Two
22:28 How to Investigate Properly
25:09 Tools for Root Cause
26:20 Problem Statement Basics
27:48 Wrap Up and Where to Find

Georg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn: https://www.linkedin.com/in/georgdigel/

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.