073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal
On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard So...
22 Helmi 202319min
072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa
On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through: - Eliminating the need for instruction through good design - Drug/De...
15 Helmi 202353min
071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols
On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses: -Translating lessons from the Steel Industry into MedT...
8 Helmi 202359min
070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen
On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses: - His experience leading combination product...
1 Helmi 202350min
069 - EU MDR Extension with Michelle Lott
On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry. If you'd like to hear more about Michelle checkout episod...
25 Tammi 202317min
068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge
On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRR...
18 Tammi 202347min
067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True
On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer. • Following career tracks, "experience", and non-linear career prog...
11 Tammi 202347min
066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: Her career at West Pharmaceuticals starting in the lab and ret...
4 Tammi 202355min
