เกี่ยวกับตอนนี้
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.
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.
ภาษาอังกฤษ
สหรัฐอเมริกา
ในตอนนี้
สำเนาบทสนทนา 🔗
Are you the producer of this podcast?
Add a podcast transcript
Need Audio-to-Text?
Transcribe with Listen411 in Just 60 Seconds
ค้นหาตอนที่ผ่านมา
ค้นหาตอนที่ผ่านมาของ Let's Combinate - Pharma + Medical Devices with Subhi Saadeh
ตอนอื่นๆ ใน PODCAST นี้
In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery device market is headed and what it takes for new technologies to actually make it to patient…
After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change.
Starting now, new episodes will go live Mondays at 5:00 AM CT.
To everyone who watches, listens, shares, or has been part of the journey: thank you. This podcast has been one of the most enriching things …
Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.
In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually means, the difference between sampling by attributes and variables, and the risk involved when we …
PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today.
In this video, I walk through where PI 006-4 fits withi…
Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve.
In this video, I share the lessons I learned as I moved from being audited and sup…
ข้อสงวนสิทธิ์: พอดแคสต์และอาร์ตเวิร์คที่ฝังอยู่ในหน้านี้มาจาก Subhi Saadeh ซึ่งเป็นทรัพย์สินของเจ้าของและไม่มีส่วนเกี่ยวข้องหรือรับรองโดย Listen Notes, Inc.
