Combinate Podcast - Quality in Pharma and Medical Devices Subhi Saadeh

On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them! 



If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.



Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through:


Training programs at companies that had consent decrees
The difference between good training and bad GMP training
Competence in knowledge work
Human Error 

Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 years in pharmaceutical, biotechnology, tissue culture and medical device development and manufacturing environments. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, Customer Service and senior management. Now, as a training system consultant, she works with clients to design and deliver custom training and build/remediate training systems, including in support of regulatory audit observations and commitments. Joanna has been a GMP TEA member since 2001, and now serves on the Board of Directors as an Advisor. She is one of the founders of the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011. Joanna writes a popular article series for Pharmaceutical Online on the people side of pharma & GMP, provides monthly interactive web courses through LifeScience Training Institute, and through her JGTA, LLC business, authored GMP Training Can Be Fun! along with an ever-expanding line of GMP training games and activities.

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 

- FDA Drug Shortages Report 

- Drug Shortages and Drug Pricing 

- How he approaches Mastering new skill sets and building deep understanding in new areas

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.

On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through:

- Article 117 requirements for Combination Products in EU

- Notified Body Opinions, Timelines, and Interactions\

-Reporting for Combination and when does Eudamed Apply

Christiana is a medical device and combination product professional within the Medtech and Pharma industry. She worked for both mid size and global manufacturers but one of the largest Notified Body TÜV SÜD, where she was responsible for Combination Products in her last role. Over the years she gained profound expertise in auditing QMS / MDD / MDR, assessing technical documentation incl. biocompatibility of a wide range of class IIa products. She is a certified auditor for ISO 13485 (TÜV SÜD) and QMB (TÜV SÜD). Christiana’s main focus and experience as SME is Article 117 MDR.  Within TÜV she was overall responsible for implementing and improving the NBOp assessment process within TÜV SÜD for the DACH & Nordics region. She is a recognized conference speaker for drug device combination products, biocompatibility and EU medical device regulation.

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 Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO)
Clifton Ericcson
How concepts/tools like these fit into the ISO14971 and ISO TR 24971 framworks

Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

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/Device Combination Product Usability
- Collaborating with OXO on a Pre-Filled Syringe
- Creating the worlds first toothbrush designed for children
- Usability and his book on simplifying baseball

Dan Formosa is the Founder of ThinkActHuman and is an award-winning researcher in the fields of usability, biomechanics and design. From 1981 to 1990 he helped create Smart Design, a multi-awarding winning company that works across the physical and digital to design meaningful experiences. He has worked with clients such as Ford, HP, Johnson & Johnson, LG Electronics, Microsoft, OXO, and UCB. Dan’s original work on OXO Good Grips kitchen tools helped them become a symbol of inclusive design. He hosts the "Well Equipped" series on Epicurious and has had millions of views on his usability and design lessons/recommendations for household products. 
Links
Well Equipped Series on Epicurious: 5 TikTok Gadgets Tested By Design Expert | Well Equipped | Epicurious - YouTube
About me - DAN FORMOSA