Episódios
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On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC.
In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program.
Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations.
Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them.
Chapters:00:56 Understanding FDA Compliance Programs02:33 Types of FDA Inspections03:04 Mock Audits and Process Validation03:45 Combination Product Manufacturer Definition04:38 Inspection Guides and Compliance06:47 Supplier Controls and Responsibilities09:20 Challenges in Mock Pre-Approval Inspections16:32 Supplier Management and Quality Agreements24:19 Contract Manufacturers and Design Control25:03 Conclusion
Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.
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On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct.
Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the significant time and resource investments required for successful IVD development.
----------------------------------Chapters:Exploring In Vitro Diagnostics with Devin CampbellIn this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of Product Know You, to discuss in vitro diagnostics (IVDs). They delve into various aspects of IVD development, including the clinical implications, risk management, and distinctions between companion diagnostics and precision medicine. They also cover regulatory pathways, lab-developed tests, and the rigorous validation processes involved. The conversation aims to demystify the complexities of IVDs for professionals in pharma and medical devices.
--------------------------------------00:00 Introduction 01:58 Understanding In Vitro Diagnostics (IVDs)05:26 Companion Diagnostics and Precision Medicine08:49 Lab Developed Tests (LDTs)12:39 IVD Development Process15:27 Risk Management in IVDs20:17 Clinical Testing and Validation29:12 Challenges and Considerations in IVDs37:04 Conclusion and Contact Information
Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system and the impact of sterilization processes on functionality. Fran also discusses the scope of USP 382, covering vials, syringes, pens, IV bags, and blow-fill-seal containers, emphasizing the need for harmonization with ISO standards. The episode highlights the necessity for pharmaceutical sponsors to generate data on the system to comply with USP 382 and prepare for its 2025 implementation.00:00 Introduction to the Combinate Podcast01:08 Understanding USP 382 and Its Importance01:41 Differences Between USP 381 and USP 38203:50 Challenges and Responsibilities in Compliance07:49 Impact of Sterilization on Stoppers11:11 Upcoming Changes and Industry Adaptation15:21 Functional Performance Tests and System Understanding19:04 Broader Scope: IV Bags and Alternative Packaging21:33 Conclusion and Contact Information
Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.
Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.
Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001
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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380).
In this episode, Etienne and I discuss:
02:50 The Start of the Combinate Podcast
06:00 Efficiency and Tools in Podcast Production
08:40 Understanding Combination Products
09:43 Regulatory Frameworks and Definitions
13:46 Challenges and Misconceptions in the Industry
20:47 Evolution of Regulations: QMSR and Part 4
22:05 Exploring Unique Podcast Episodes
25:56 The Pyramid of Regulations
30:40 The Role of Coaching and Mentorship
32:59 Trends in Combination Products
35:23 Recommended Books and Final Thoughts
37:04 Encouragement for Lifelong Learning
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.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses:
00:00 Introduction
02:29 Understanding the FDA's New Guidance:
05:05 Challenges in Supplier Management and the
08:22 Navigating Change Management
11:43 Insights on Regulatory Compliance
25:26 The Importance of Dimensional Tolerances
32:56 Closing Thoughts
Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.
Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.
Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001
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On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:18 The Personal Impact of Vision Loss35:40 Book Recommendations and Final Thoughts
Maysaa Attar is the Senior Vice President of R&D at Bausch & Lomb, leading global pharmaceutical and consumer product research and development. She has held prominent leadership positions at Abbvie and Allergan and holds a PhD in Pharmaceutical Sciences from the University of Southern California (USC), where she also serves as a professor.
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On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:01:01 Recap of the Last Episode01:23 Understanding the Freeze Drying Environment01:46 Freeze Drying Equipment and Processes03:01 Cleaning and Validation in Freeze Drying03:58 Loading and Automation in Freeze Drying06:27 Detailed Breakdown of Freeze Drying Components15:24 Refrigeration and Temperature Control17:25 Vacuum Systems and Filter Racks20:18 Challenges in Freeze Drying and Validation28:08 Advanced Freeze Drying Considerations31:38 Conclusion and Contact Information
David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals 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. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin here or at [email protected]
**About David Simoens:**
David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.
**Key Specializations:**
- Aseptic Fill/Finish including Lyophilization
- New Product Introductions
- Cytotoxic and High Potency Environments
- Integrated Commissioning, Qualification, Validation
- Radiopharmaceuticals
- Business growth and optimization
- Enterprise Quality Management Systems
- Career coaching
**Contact Information:**
For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.
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On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. Leo highlights the challenges and strategies for documenting standards assessments and emphasizes the importance of leveraging existing standards to avoid unnecessary development. The episode also covers tips for small and large companies, the significance of early research, and the essential stakeholders involved in standards assessment.
Chapters:
00:00 Introduction to the Combinate Podcast
01:03 Guest Introduction: Leo Eisner
01:19 Understanding Standards Applicability
07:45 Documenting Standards Assessments
12:03 Challenges and Best Practices
20:56 Final Thoughts and Contact 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/
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On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through:
David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in biomedical engineering and postgraduate research at the University of Muenster, Germany, as well as work for the Centre for Global eHealth Innovation (Toronto) and GE Healthcare (Wuxi, China), he joined Design Science’s U.S. office in 2016. At Design Science, David supports clients in developing and approving medical devices and combination products for the U.S and E.U. markets. He currently is leading efforts to open Design Science’s first European office in Munich, Germany. He completed his PhD at the University of Münster in 2024.
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On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.
David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of various drugs on the process, types of stoppers, and differences between lyophilized and liquid-filled vials. David shares insights on the technical aspects, including pressure, temperature, and time management, as well as equipment considerations and challenges in the lyophilization cycle.00:00 Introduction and Guest Introduction01:21 Podcast Overview and Purpose02:12 Importance of Lyophilization03:04 Lyophilization Process Explained04:35 Vial Filling and Stoppering Differences09:44 Freeze Drying Process15:45 Primary and Secondary Drying16:56 Backfilling and Final Steps30:20 Equipment and Technology34:41 Conclusion and Guest Contact Information
David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals 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. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin here or at [email protected]
**About David Simoens:**
David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.
**Key Specializations:**
- Aseptic Fill/Finish including Lyophilization
- New Product Introductions
- Cytotoxic and High Potency Environments
- Integrated Commissioning, Qualification, Validation
- Radiopharmaceuticals
- Business growth and optimization
- Enterprise Quality Management Systems
- Career coaching
**Contact Information:**
For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.
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On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses:
01:18 Understanding Regulatory Policy
03:18 Ryan's Career Journey
05:08 Challenges in Regulatory Harmonization
06:54 Legislative Frameworks and Regulatory Differences Globally
11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act)
15:51 International Harmonization Efforts
22:36 Combination Products and Policy Work
30:10 The Importance of Advocacy and Education
35:22 Closing Thoughts and Personal Insights
Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing
Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor’s degree in Bioengineering from the University of California, Berkeley, his doctorate and master’s degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.
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On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery.
David and I discuss:
00:00 Introduction and Guest Overview
00:04 David DeSalvo's Career Journey
02:13 Understanding Injection Systems
04:22 Early Career at BD
10:51 Transition to SHL
17:50 Starting a New Venture
24:54 Experience at Emergent BioSolutions
29:40 Current Role at Kindeva
32:56 Book Recommendation and Conclusion
David DeSalvo is the Vice-President of Combination Product Development at Kindeva Drug Delivery. He is an expert in drug delivery devices (combination products) and has invented, designed, developed and launched multiple devices. His work has resulted in dozens of highly successful unique drug-device combination products, including many industry-first innovations.
https://www.daviddesalvo.com/ -
On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry.
Industry Comments are DUE 9/29/2024.Alan Stevens 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.Rumi Young, Meng, RAC is the Director of Regulatory Policy at Novo Nordisk. Rumi joined Industry from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.
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On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins02:23 Material Qualification in Drugs vs. Devices04:00 Quality Standards in Different Industries08:54 Quality Tools and Their Applications11:22 Material Qualification and Supplier Management26:37 Regulations and Quality by Design27:45 Closing Remarks and Guest's Current Work
Ben's Article: Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)
Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
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On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington.
Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and president of ASQ and has multiple quality awards named after him. He's currently the CEO of Harrington Management systems, an International consulting firm focused on performance improvement, strategic planning, and organizational alignment for both private and public organization. -
On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through:
00:00 Introduction and Guest Overview
00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity
03:41 Medical Device Cybersecurity: Challenges and Risks
05:51 Freelance to Entrepreneurship: Founding Blue Goat Cyber
07:05 Cybersecurity in Medical Devices: Key Considerations
16:55 The Importance of Software Bill of Materials
27:48 Hiring for Cybersecurity: Skills Over Certifications
29:36 Book Recommendations and Closing Remarks
Christian Espinosa, founder and CEO of Blue Goat Cyber, is a leading medical device cybersecurity expert, driving advancements prioritizing patient safety and data integrity. His proactive and innovative approach defines his work. As the author of "The Smartest Person in the Room" and "The In-Between: Life in the Micro," Christian shares his journey from competitive to compassionate leadership. An avid adventurer, he enjoys extreme sports, heavy metal music, and spicy foods. His achievements as a certified skydiver, PADI divemaster, and Ironman triathlete underscore his commitment to personal growth and transformative leadership.
https://www.linkedin.com/in/christianespinosa/https://twitter.com/Ironracerhttps://bluegoatcyber.com/https://christianespinosa.com/ -
This is a solo episode. On this episode, Subhi goes through:
01:51 Draft FDA Guidance - Platform TechnologyDesignation Program for Drug Development Guidance for Industry
13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notifiedbodies with respect to the implementation of theRegulations on medical devices and in vitro diagnosticmedical devices (Regulations (EU) 2017/745 and (EU)2017/746)
18:25 USP - <1157> USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products
20:10 Race Recap: Sugar Badger 50K
26:51 Conclusion
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. Subhi is an Ironman Triathlete and a Marathoner/Ultramarathoner.
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On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:
00:31 Larry's Perspective on Quality
03:21 Importance of KPIs in Management Review
04:13 Management Review and Control
09:09 Operational Framework and Business Structure
18:46 Effective Business Processes
24:42 Understanding Role Expectations and Aggregating Work
25:51 Management Review: Strategy and Tactical Levels
28:47 Operational and Systemic Levels of Management
30:15 Balancing Capability and Capacity
31:37 Improvement and Execution in Business Operations
37:25 The Role of CAPA in Quality Management
44:54 Building a Culture of Quality and Continual Improvement
46:36 Conclusion and Resources for Further Learning
Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at [email protected]
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On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through:
00:38 Exploring Reliability in Combination Products
01:17 The Importance of Subscribing and Feedback
01:36 Alan Stevens Shares His Expertise
02:40 Understanding Reliability: Definitions and Nuances
03:46 Component vs. System Reliability in Device Design
08:55 From FDA Reviews to Industry Insights
11:29 Fault Tree Analysis and Risk Management
14:17 Setting Reliability Expectations for Combination Products
15:32 Navigating Risk Culture and Acceptable Levels of Risk
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.
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On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through:
00:29 Design Changes When No DHF Exists
03:30 Challenges and Strategies in Document Management
04:49 Improving Design Inputs and Risk Management
21:37 Leveraging Tools for Better Traceability and Compliance
Charles Ventura is the Founder of Ventura Solutions and CEO of HemoTek. Chuck is a leader in the Medical Device & Combination Products space with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support.
https://ventura-solutions.com/
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