Infusion Drug Delivery Videos

1. The Role of ISO 13485 in the New QMSR 7/11/2024

   What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.

2. An EDDO Identification Tutorial For A Prefilled Syringe (PFS) 4/23/2025

   In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for a prefilled syringe (PFS) to demonstrate a template for identifying EDDOs.

3. Risk Management and the New QMSR 7/11/2024

   What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses when and how organizations will now need to address risk management within the context of design development and controls.

4. Deploying Immunologic Viral Agents To Target Cancers With Oncolytics Biotech's Thomas Heineman 2/27/2025

   In this episode of Sit and Deliver, host Tom von Gunden talks with Oncolytics Biotech’s Chief Medical Officer Thomas Heineman about deploying oncolytic viral agents to ensure successful arrival at lymph nodes and at primary and metastatic tumor sites.

5. What Is There to Learn from a Combination Products Handbook? Plenty! 10/15/2024

   In this initial episode of The Combination Products Handbook: The Series, a chapter-by chapter videocast series introducing topics from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023), host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors.

6. Preconditioning Devices under EDDO Guidance 10/9/2024

   What does the FDA’s guidance on Essential Drug Delivery Outputs (EDDOs) mean for activities involved in preconditioning the device delivery components of combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, discusses the likely intent and impact of EDDOs on preconditioning for both manufacturers and sponsor companies.

7. Applying Control Strategies to EDDOs 10/9/2024

   After Essential Drug Delivery Outputs (EDDOs) have been identified, each will need to be controlled during the development of a drug delivery device.  In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC provides the rationale for a risk-based approach to EDDO control strategies.

8. When And How To Use A UFMEA During Device Design 12/11/2024

   When and how might using a uFMEA (Use Failure Mode Effects Analysis) tool benefit biopharma companies addressing regulatory expectations for analyses of risk and/or human factors? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss potential differences in the contexts, purposes, and degrees of detail in information presented for review.

9. What Is the Impact of the New QMSR on 21 CFR Part 4? 7/11/2024

   In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.

10. Managing Combination Products Post-Market 3/25/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 8 on post-market lifecycle management from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Khaudeja Bano.