Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

Let's Combinate - Drugs + Devices with Subhi Saadeh episodes

April 17, 2024132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses:
00:56 Evolution of Industry Standards

02:00 The Impact of Standards on Medical Device Development

02:10 Standards and Regulatory Challenges

02:42 Standards in Medical Devices and Emerging Technologies

13:19 The Auditing Experience

17:59 The Challenge of Maintaining and Updating Standards

29:49 Concluding Thoughts and Where to Find More Information
Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.
He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.

Links:
Website: https://eisnersafety.com/

Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of

page (1/2 way down)

LinkedIn: linkedin.com/in/leoeisnersafetyconsultants

Contact Us: https://eisnersafety.com/contact_eisner_safety/

Schedule a call: https://eisnersafety.com/schedule-call/
U.S. TAG 62D - https://www.aami.org/detail-pages/opentext-gateway-standards-committee/u.s.-tag-62d---electromedical-equipment-committee

EV - WG 13 - Lens Removal and Vitrectomy Devices Working Group- https://www.aami.org/detail-pages/opentext-gateway-standards-committee/ev-wg-13---lens-removal-and-vitrectomy-devices-working-group

JWG 9 Lens removal and vitrectomy devices for ophthalmic surgery - https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:2472,25
32 min
April 10, 2024 131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:
- Assessing Drugs, Devices, and Combination Products for Sterility Methods
- Regulatory Frameworks and EMA's Decision Tree (Link)
- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure sterilization, glass bead sterilization, infrared, microwave
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.
43 min
April 03, 2024 130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses:
00:58 Exploring the Impact of QMSR on Medical Device Companies
02:19 UDI Regulations
05:18 Understanding the FDA's Approach to QMSR and Compliance
18:02 The FDA's Inspection Techniques and the Future of QMSR
31:55 Where to Find Aaron and Closing Thoughts
Aaron Snyder is a quality management systems expert and is the VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.
33 min
March 27, 2024 129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens
On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. And the roles of standards and guidance in combination product approval.
03:32 The Story Behind 'Captain' Allen Stevens
06:52 The Challenges of Infusion Pumps and Recalls
13:34 The Intricacies of FDA's Rule-making and Guidance Process
21:44 The Future of Reliability in Combination Products
30:46 A Book That Changed Life: Systems Thinking in Safety
32:44 Wrapping Up: The Impact of Engineering on Public Health
Alan is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.
33 min
March 20, 2024 128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso.
Vin discusses:
01:35 Journey from Premed to FDA Investigator: VIN's Story
07:25 Understanding the Impact of QMSR on Industry
16:24 The FDA's Approach to Inspections and Compliance
27:45 The Shift Towards Quality Culture in FDA Inspections
31:07 Real-World Insights
35:34 The Impact of Quality Culture on Inspections
44:22 Transitioning from FDA to Industry
49:51 Building a Career in Quality Engineering
Vincent (Vin) Cafiso, serves as the Founder and Managing Consultant of Practical Compliance Solutions. His professional journey commenced as an FDA investigator, after which he transitioned into the industry. Throughout his career, he has held diverse positions at well-established medical device companies such as BD, Smith & Nephew, BioArray Solutions, and Impulse Dynamics. He consults on medical device quality management and can be reached on linkedin here or via the web on https://practicalcomplianceresults.com/about
53 min
March 13, 2024 127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk".
In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the second half of the episode talk about risk acceptability charts, risk & quality policy, explaining vs. justifying risk based decision making with regards to the traffic light charts that most companies use for risk acceptance.

Episode Chapters:
02:00 Interpreting the QMSR and Its Implications
05:56 Impact of QMSR on Risk Management
08:34 Risk Management in Practice
12:09 Insights from FDA Inspections and Warning Letters
23:30 The Importance of Process-Based Approach
24:57 Deep Dive into Risk Policy and Risk Acceptability
26:05 Understanding the Framework of 14971
26:42 The Role of Quality Policy in Risk Management
27:32 Risk Control
29:47 Risk Acceptability in Risk Policy
30:59 Understanding Risk Matrix
32:16 Risk Control and Quality Policy
41:00 Understanding Risk Acceptability Charts

Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.
49 min
March 06, 2024 126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd
On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses:

01:02 Venturing into Combination Products
02:46 Andy's Journey into Healthcare Space
04:48 Challenges in Deep Brain Stimulation
08:55 The Impact of working with Andy Grove
10:42 The Struggle with Parkinson's Disease
13:20 The Speed of Product Development
16:09 Collaboration Challenges in Combination Product Space
19:17 The Role of Regulatory Teams
23:12 The Importance of Team Formation and Alignment
33:20 The Vision for Coalition
34:44 Conclusion

Prior to founding COALITION, a collaboration consultancy focussed on speeding progress in highly regulated industries, Mat spent 20 years leading companies within the MedTech and Combination Products spaces. Over this time, Mat developed a formula for success on how to turbo charge collaboration and progress where effective cooperation between multiple disciplines is essential. The key learnings from many successes and plenty of challenges have been distilled in to the approach at the core of COALITION's services and detailed in Mat's upcoming book - "Collaboration - where it's difficult, it's vital."

Email: [email protected]
Website: www.coalition.ltd
Linkedin: https://www.linkedin.com/in/mat-stratton-a6269317/
36 min
February 28, 2024125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024.

0:00 Introduction
05:09 Initial Reactions to the idea of the QMSR
06:57 History of the Device cGMP's, QSR, and QMSR
11:52 What's changing in 21 CFR 820?
24:59 What's changing in 21 CFR 4 and Combination Products
33:20 Comments Review and Final Thoughts

Links:
QMSR Final Rule Amendments: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments

QMSR Final Rule FAQ: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked

21 CFR 820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820?toc=1

21 CFR 4 (Changes Introduced): https://www.ecfr.gov/compare/2024-02-02/to/2024-02-01/title-21/chapter-I/subchapter-A/part-4/subpart-A

Device cGMP's 21 CFR 820 (1978): https://archives.federalregister.gov/issue_slice/1978/7/21/31497-31571.pdf#page=12

Reserved Definition: https://www.archives.gov/federal-register/cfr/about.html#:~:text=An%20agency%20uses%20%22%5BReserved%5D,a%20printing%20or%20computer%20error.

ANSI View Only Copy of ISO13485 (No Cost): https://ibr.ansi.org/Standards/iso1.aspx

Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. 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.
43 min
February 21, 2024 124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
On this episode, I was joined by Andy Robertson, founder of CQE Academy.

In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out of the comfort zone by exploring opportunities outside the quality field. The discussion also highlighted the value of certification courses for professional development. Lastly, they recommend several books for personal and professional growth.

00:01 Introduction and Guest Introduction
04:56 #1: Mentors, Mentors, Mentors: The Importance of Mentorship in Quality Engineering
13:48 #2: The Value of Tough Assignments in Professional Growth
18:44 The Power of Lifelong Learning
19:08 #3: The Importance of Lifelong Learning
20:04 The Struggle of Choosing What to Learn
22:28 Balancing Professional and Personal Learning
23:24 #4: The Underrated Value of Soft Skills
27:43 #5: Leaving Quality
29:21 #6 (Bonus) The Benefits of Professional Certifications

Andy's Website: https://cqeacademy.com/
Youtube: https://www.youtube.com/@CQEAcademy
32 min
February 14, 2024 123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker
On this episode, I was joined by Peter Baker, President @ Live Oak QA.

The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical devices and clinical trials, and how operational changes in the mid-2010s streamlined FDA's specialized areas. The speaker discusses his inspection methods and how a focus on critical thinking rather than procedural controls leads to more substantial findings, particularly in data integrity within quality control labs across industries. He emphasizes the need for quality-driven, honest investigations in addressing deviations and believes a switch from a compliance-focused mindset to a quality-oriented one should be the future standard.

00:00 Early Career and Diverse Experiences
00:43 Understanding FDA Regulations and Import Work
02:28 Moving Overseas and Program Realignment
07:44 Challenges with Data Integrity
10:33 Understanding the Root Cause of Data Integrity Issues
10:54 The Role of Data Governance and Regulatory Guidance
22:24 Challenges of Field Inspections
24:07 Manipulation of Product Quality
25:26 Jurisdiction and Quality Systems
27:53 Lab Controls and Data Integrity
36:04 Addressing Unknown Discrepancies
39:34 The Importance of Honest Reporting

Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11.

PIC/S Guidance on Data Integrity: https://picscheme.org/docview/4234
Live Oak: https://www.liveoakqa.com/
Peter's Blog: https://www.liveoakqa.com/blog-1
46 min