Let's Combinate - Drugs + Devices with Subhi Saadeh

On this episode, I was joined by ⁠Amy Wilson and Cliff Berry, authors of "Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing".

Amy and Cliff walkthrough:

Amy Wilson: Amy has more than 20 years of biopharma manufacturing experience, focusing on human & organizational performance, operational excellence, risk management and technical training. She has led a global integration of Human & Organizational Performance within biopharma manufacturing. Amy has a Ph.D. in Industrial Engineering from North Carolina State University.

Cliff Berry: Cliff has worked in the domain of Human & Organizational Performance for over 20 years. He has experience in commercial nuclear electric generation, electric transmission & distribution, gas distribution, nuclear plant systems controls hardware & software integration, and most recently in biopharma manufacturing since 2015 where his primary focus is on creating more quality success. Cliff has a M.S. in Occupational Ergonomics & Safety from the University of Massachusetts Lowell.

On this episode, I was joined by Megan Polidano, Head of Clinical and Regulatory affairs at Vaxxas.

Megan walks through:

Megan Polidano is the Head of Clinical and Regulatory affairs at Vaxxas. Megan has worked in regulatory affairs since 2007 and have worked for large pharmaceutical and medical device companies as well as small biotechnology companies in Australia and in the US.

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:

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]

On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality.

On this episode I was joined by Bijan Elahi, Award winning Medical Device Risk Management author, educator and consultant.

Bijan walks through:

Bijan Elahi has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he is also teaching a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Contact: You can contact Bijan at his website: https://www.medtechsafety.com

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:

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]

On this episode I was joined by Heather Johnson who's the CEO of Ingenium.

In this episode, expect to learn:

• Why Waste Management in Pharma might be more complicated than you might think

• Different kinds of sharps, why sharps are challenging and what happens to sharps containers?

• Waste potential and repurposing orphan chemicals

• And what Zero Waste means for sustainability

Heather Johnson has over 25 years of expertise in the hazardous waste management industry as a C-level Executive, Sales/Marketing Director and Account Manager. As a seasoned entrepreneur who has launched several existing waste management firms, Heather is a founding partner of INGENIUM and currently serves as its Chief Executive Officer.

Heather’s innovative vision into sustainability for regulated waste management has positioned INGENIUM as an industry leader in innovative waste to energy programs and has provided INGENIUM’s clients with environmentally friendly alternatives to waste disposal, including zero waste initiatives. Heather is well known for her participation in the industry, including her past presidency of BioNet, a non-profit association devoted to biological safety. She has also served on the Board of Directors for several local non-profit organizations and has made community service a priority for INGENIUM and its employees.

On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD).

Rumi walks through:

Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD 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.