Afleveringen
-
Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational harmony, addressing both internal and external collaborations. Additionally, Subhi explores the complexities of regulatory differences between regions, advocate for standardized quality agreements, and stress the significance of relationship management between sponsors and contract organizations (CXOs). The ultimate goal is to achieve regulatory and operational harmony within the combination products space.00:00 Introduction and Personal Insights00:28 Defining Harmonization02:38 Challenges in Regulatory Harmonization03:43 Operational Harmony and Internal Collaboration10:38 Sponsor and CXO Harmonization14:15 Internal Drug and Device Harmonization17:37 Solutions and Final Thoughts20:41 Conclusion and Thank You----------------------------------------This talk was given at the PharmaED Resources Pre-filled Syringes & Injection Devices 2024 Conference: Exploring the Future of Parenteral Combination ProductsDecember 4-5, 2024, La Jolla, CANote: Apologies for the audio not being of the quality you're used to —this is after hours of post-production. Trust me, the original was worse. 😅
-
In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact on the overall success of drug development programs. The episode also explores the integration and collaboration required across various functions like R&D, quality, regulatory, and commercial teams to create and refine a robust TPP.
00:00 Introduction and Welcome
00:26 Meet Marta: CEO of Radius Research
00:58 Understanding Target Product Profiles (TPPs)
01:44 The Importance of TPPs in Drug Development
01:59 Defining a TPP
03:22 TPP as a Strategic Document
05:28 TPP in Preclinical and Clinical Stages
07:09 Challenges and Misconceptions in TPP Development
14:27 Regulatory Considerations for TPPs
14:53 Sections of a TPP
39:07 Understanding Toxicology Evaluations
39:34 FDA Requirements for Pre-IND Talks
39:51 TPP and Toxicity Thresholds
41:41 Go/No-Go Criteria in TPP
42:50 PKPD and Drug Distribution
45:40 Drug Formulation and Quality Attributes
46:36 Regulatory Strategy and 505(b)(2) Pathway
52:34 Differentiation and Risk Assessment
01:03:42 Transition from Discovery to Development
01:07:48 Combination Products and Delivery Systems
01:09:35 Conclusion and Contact Information
Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer. She can be reached at [email protected]
-
Zijn er afleveringen die ontbreken?
-
In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug products. He explains the importance of these standards in preventing health risks such as embolisms and allergic reactions. The episode outlines the methods used for testing, including light obscuration and microscopic particle count tests, as well as the required visual inspections for visible particles. Subhi also discusses the differences in scope between USP and ISO standards and emphasizes the critical role of operator training and clean handling practices in ensuring product safety.00:00 Introduction to Today's Topic: Particles00:48 Understanding USP and Its Role02:52 Diving into USP 788: Sub-Visible Particles05:40 Testing Methods for Sub-Visible Particles07:00 Acceptance Criteria for Sub-Visible Particles08:53 Exploring USP 790: Visible Particles11:12 Inspection Techniques and Practical Considerations12:50 Conclusion and Wrap-UpSubhi 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.
-
In this episode of Let's Combinate, host Subhi Saadeh delves into the significance of ICH Q12 for the pharmaceutical industry, especially concerning established conditions and drug-device combination products. Subhi explains how Q12 enhances lifecycle management, streamlines post-approval changes, and improves regulatory alignment. He breaks down critical concepts such as established conditions, product lifecycle management (PLCM), and post-approval change management protocols (PACMPs). Subhi outlines the benefits and challenges of adopting ICH Q12 and encourages listeners to familiarize themselves with its guidelines.00:00 Introduction and Welcome00:31 Topic Overview: ICH Q12 and Established Conditions01:01 Understanding ICH Q12: Life Cycle Management02:26 Importance of Post Approval Changes04:11 Key Concepts of ICH Q1206:14 Practical Example of ICH Q12 Application07:45 Benefits and Challenges of ICH Q1210:32 Final Thoughts and Encouragement11:26 Closing Remarks and Contact Information
-
In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, the host discusses the core concept that quality, when properly managed, incurs no extra cost, aligning with prevention rather than fixing issues.
The episode dissects five erroneous beliefs about quality, including the idea that quality equates to luxury, that it is intangible and immeasurable, and that quality issues stem from workers or are confined to the quality department. Emphasizing a holistic and preventative approach, the discussion reflects on different quality philosophies and the importance of leadership alignment. The episode concludes by encouraging listeners to read the book themselves for a deeper understanding of quality management principles.00:00 Introduction to 'Quality is Free'00:24 The Impact of 'Quality is Free'01:30 Key Concepts: What We Think We Know is All Wrong02:23 5 Erroneous Beliefs About Quality06:26 Measuring Quality: Cost and Prevention09:09 Quality "Responsibility" in Different Departments15:02 Aligning Leadership and Quality Management17:05 Conclusion 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.
-
In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. He discusses the origins, key elements, similarities, and differences of these standards and guidelines, explaining their application in the development and manufacturing of combination products. Saadeh also highlights the definitions of risk, historical developments, and updates in these frameworks, particularly ICH Q9's recent refinements on managing subjectivity and the formality of risk assessments. The episode compares the structured approach of ISO 14971, focused on patient safety through the entire lifecycle of medical devices, with the broader risk management scope of ICH Q9, which encompasses various elements within the pharmaceutical process. Saadeh provides insights into specialized tools, the concept of state-of-the-art, and the importance of verification of implementation and effectiveness in risk management plans. Listeners from regulatory, quality, product development, and risk management fields will gain a comprehensive understanding of balancing these crucial frameworks for combination products.00:00 Introduction to Risk Management00:21 Understanding ISO 14971 and ICH Q901:02 Key Elements and Differences01:35 Deep Dive into ISO 1497105:08 Deep Dive into ICH Q908:53 Comparing Risk Management Tools14:21 Combination Products and Risk Management18:34 State-of-the-Art and Residual Risks21:35 Verification and Effectiveness22:50 Conclusion and Final ThoughtsSubhi 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.
-
In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses key elements like analytical method transfer and process validation for drugs, and the DHF and risk management in device design. Subhi looks into the differing complexities, regulatory submissions, and validation requirements for both processes. The episode concludes with commercializing combination products, emphasizing project management, regulatory submissions, and post-market surveillance.00:00 Introduction to Combination Products00:55 Understanding Drug Tech Transfer04:04 Exploring Device Design Transfer08:49 Key Differences Between Drug and Device Transfers14:30 Commercialization of Combination Products17:54 Conclusion and Final Thoughts
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.
-
In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. They examine models like centralized, decentralized, and federated structures, supported by industry benchmarks and practical experiences. The conversation emphasizes the necessity of centralized ownership for consistent quality outcomes, despite quality being everyone's responsibility. Additionally, they explore the nuances within pharmaceutical companies, referencing a McKinsey study that underscores the importance of cultural and procedural elements over structural setup. Distinctions between Quality Assurance and Quality Control are clarified, focusing on the need for proactivity and integration for optimal results. This episode provides comprehensive insights into the structural, cultural, and procedural dimensions of effective quality management.00:00 Introduction and Guest Welcome00:19 Questioning the Quality Unit's Independence01:19 Avoiding Conflicts of Interest in Quality03:39 Organizational Structures and Quality09:09 Centralized, Decentralized, and Federated Quality Models12:06 Understanding Quality Reactivity12:20 Insights from the McKinsey Study13:36 The Importance of Quality Culture14:23 Identifying Problematic Structures15:19 Designing Non-Reactive Quality Systems17:13 Quality Management System (QMS) Structures19:05 QA vs. QC: Key Differences22:07 Conclusion and Final Thoughts
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.
-
In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution.00:00 Welcome and Podcast Journey00:39 Strength Training Analogy02:10 Reflecting on Three Years04:11 Significant Life Update05:46 Lessons Learned and Trusting Others07:37 Podcasting Process and Scheduling10:34 The Challenges of Editing11:21 Finding the Right Tools12:11 Promotion and Growth12:56 Consistency and Sustainability13:07 Starting a Podcast: Advice and Reflections15:52 The Future of the Show20:12 Engaging with Listeners21:12 Final Thoughts and Farewell
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.
-
In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spending adequate time on creating design inputs and the benefits of concurrent engineering to refine specifications. The discussion also covers the relationship between design inputs and risk controls, and Chuck introduces his Design Input Essentials course aimed at helping companies accelerate product development.00:00 Welcome to the Comedy Podcast00:04 Introducing Chuck Ventura00:29 The Importance of Design Inputs02:07 Challenges with Design Inputs03:07 Impact on Product Development04:18 Common Pitfalls in Design Inputs06:15 Design Verification Issues10:22 Best Practices for Design Inputs14:11 Link Between Design Inputs and Risk Controls18:45 Chuck Ventura's Design Input Course20:31 Closing Remarks
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/
-
On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc.
On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the challenges posed by longer-acting drugs, higher viscosities, and large injection volumes. Laxman also discusses his transition from large corporations to startups and the multifaceted nature of scaling up projects.00:00 Introduction to the Combinate Podcast00:56 Understanding the Intersection of Medical and Pharmaceutical Industries02:56 Challenges in Medical Devices and Pharmaceuticals03:22 Governance and Risk Management in Healthcare08:13 Transitioning from Big Pharma to Startups15:46 Trends in Injection Delivery Systems28:38 Challenges in Home Administration and Sustainability31:07 Scaling Up in the Pharmaceutical Industry32:47 Conclusion and Contact Information
Laxman Halleppanavar is currently the Head of Portfolio Strategy and Management at Credence MedSystems, leading the Injectable Device Portfolio Strategy and Management team for internal and external customer endeavors. Previously, Mr Halleppanavar was the Director - PharmSci Technical Team Lead at Pfizer. He came to Pfizer upon its acquisition of Hospira where Mr Halleppanavar was responsible for combination product development from early-stage development to manufacturing scale up leading to commercial launch. Prior to Pfizer, Mr Halleppanavar was the Program Manager at GE Healthcare responsible for development, manufacturing, and commercialization of multiple medical device/patient monitoring platforms namely, patient worn devices, blood pressure cuffs, bedside monitoring devices, networked central & remote monitoring stations.
-
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.
-
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/
-
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
-
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
-
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
-
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.
-
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.
-
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/
-
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.
- Laat meer zien
