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Recent episodes
What Auditors Are Actually Looking For — and the Psychology Behind How They Find It
Apr 28, 2026
19m 30s
Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive
Mar 9, 2023
Unknown duration
Navigating the 510(k) Process: A Q&A with Regulatory Consultant, Trey Thorsen, MS, RAC
Feb 9, 2023
Unknown duration
The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market
Nov 21, 2022
Unknown duration
Quality Management Review: Benchmarking Quantitatively!
Jul 2, 2021
Unknown duration
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| Date | Episode | Topics | Guests | Brands | Places | Keywords | Sponsor | Length | |
|---|---|---|---|---|---|---|---|---|---|
| 4/28/26 | ![]() What Auditors Are Actually Looking For — and the Psychology Behind How They Find It✨ | auditingquality compliance+4 | Sneha Saggurthi | — | — | auditcompliance+6 | — | 19m 30s | |
| 3/9/23 | ![]() Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive | The FDA Group's CEO, Nick Capman sits down with Dan Barker, CEO of Wikimotive, to explore perspectives on management and leadership. Dan shares his unique professional journey and dives into the importance of vulnerability and constant learning in leadership and management, as well as discussing other topics, including: How management can be the 'easy' side of the equation, with leadership being about ensuring management systems are built and executed effectively. Dan's non-typical career path, from cabinet maker to marketer and eventually CEO. The importance of leadership and management in enhancing people's quality of life. How good leaders and managers appreciate significant moments in their employees' lives. How enthusiasm and constant learning are important qualities for leaders. In 2023, Dan Barker was named as successor to [owner and founder] Tim Martell, accepting the role of Wikimotive’s Chief Executive Officer. Since joining the company in 2018, Dan’s extensive background in both personnel and project management, combined with his insatiable pursuit of knowledge, fueled his trajectory through nearly every role that Wikimotive had to offer. Inspiring optimizations and efficiencies along the way, the impact of Dan’s expansive knowledge, sound decision-making, and measured management style can be felt in every facet of Wikimotive’s daily operations. https://wikimotive.com/ Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/ | — | ||||||
| 2/9/23 | ![]() Navigating the 510(k) Process: A Q&A with Regulatory Consultant, Trey Thorsen, MS, RAC | The FDA Group’s CEO, Nick Capman, sits down with Regulatory Consultant Trey Thorsen, MS, RAC, to answer some of the most frequently asked questions about navigating the 510(k) premarket notification process. Trey brings experience in Class I, II, and III devices, such as active implantables with MRI functionality, external therapeutic devices indicated for pain, devices that have software functionality, transvaginal catheter systems that evaluate fallopian tube patency, sterile and non-sterile wound care devices, compression devices, surgical booms, surgical lights and devices indicated for incontinence. He also has experience with 513(g)s, Pre-Subs and CFGs, UDI/GUDID implementation, as well as EU MDR technical file development and remediation. Some of the questions Trey tackles include: "I would like to distribute a manufacturer's product under my own company name. Do I need to submit a 510(k)?" "Can foreign companies submit a 510(k)? "Besides the fees for paying a consultant to help me put this together, are there any other fees I should be aware of? "How much does a U.S. Agent typically cost?" "Do I need to register my facility before I submit a 510(k)?" "Do I need to provide documentation that my facility complies with the quality system in my 510(k)?" "Do I need to have my facility inspected to the Quality System Regulations before I submit a 510(k)?" Need expert 510(k) assistance? At The FDA Group, we help you move through the 510(k) submission process quickly and efficiently. Our regulatory affairs consultants, many of whom are former FDA personnel, have years of experience working with and within the agency. Learn more about our 510(k) consulting services and get in touch with us to access the industry's best regulatory affairs consultants. Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more » | — | ||||||
| 11/21/22 | ![]() The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market | Earlier this year, Deloitte released its Global Life Sciences Outlook report, featuring a section devoted to "transforming the talent experience." The FDA Group's CEO, Nick Capman, sat down with Larry Stevens, RAC, to unpack some of Deloitte's findings and what they might mean for life science teams looking to innovate their workforce strategies and navigate a hyper-competitive specialized labor market. Read Deloitte's full report (PDF): https://www.deloitte.com/content/dam/assets-shared/legacy/docs/perspectives/2022/gx-lshc-dei-global-life-sciences-outlook-report.pdf Some key excerpts: Page 29: _____ "Life sciences companies are still optimizing virtual ways of working, and other issues of concern for life science leaders in 2022 include: What is our talent acquisition strategy? How do we secure in-demand skills and capabilities in a competitive market? What are the “Great Resignation” effects on our company? How can we create a more meaningful talent experience? How can we become a more agile and adaptable organization?" "Life sciences companies that want to succeed in the future of work will need to be flexible in how work is done and how talent is sourced, trained, and managed. Human resources is also undergoing a massive transformation. Instead of trying to predict the future, leaders might consider how they can develop an open culture of experimentation, learning, and iteration." Page 30: _____ "Throughout the next year, many life sciences companies will continue to grapple with how to solve these issues, and each will land in a different place on the spectrum. The 'Great Resignation' is calling for a 'Great Re-imagination', and a winning strategy includes creating value for workers as whole human beings and key stakeholders—including internal and external workers. "Successful companies are no longer concentrating on just hiring the smartest people, but rather on having access to the smartest people. New workforce ecosystems include in-house employees combined with a diverse mix of external contributors—e.g., contractors, app developers, other gig workers, external partners and suppliers, and even software bots. According to recent research from MIT Sloan Management Review and Deloitte, only 28% of global managers feel they are sufficiently preparing to manage a workforce that will rely more on external participants." "One agile strategy is to shift from a hierarchical structure to a more team- and networked-based approach that may combine internal and external workers into specialized or cross-functional teams." Page 35: _____ "According to a recent Fortune/Deloitte CEO Survey, attracting and retaining talent in a tight labor market has ascended to the top of CEOs’ list of strategic priorities. Companies should reimagine work as a landscape of tasks and skills that dynamically evolves with business priorities." _____ The FDA Group helps life science companies act on all of these recommendations, enabling RA/QA/Clinical teams to rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and connect with us: https://www.thefdagroup.com/ | — | ||||||
| 7/2/21 | ![]() Quality Management Review: Benchmarking Quantitatively! | The FDA Group’s CEO, Nick Capman, sits down with Tobias Kuners of Koenders, Managing Consultant at Tob Management, to discuss his integrated approach to implementing and interpreting qualitative and quantitative metrics in the GMP and non-GMP sides of a life science business. Read his full column in Pharmaceutical Online: https://www.pharmaceuticalonline.com/doc/quality-management-review-benchmarking-quantitatively-0001 Tobias has worked with Biogen, Ipsen, Thermo Fisher, Kite Pharma, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led the design, engineering, and construction of multiple facilities to meet cGMP requirements. He performs audits, identifies gaps, and develops remediation plans, working within organizations to assist with deviation investigations and CAPA implementation and to develop scientific, risk-based solutions. You can contact him at tobias.kunersofkoenders@tobmanagement.nl. Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started: www.thefdagroup.com. | — | ||||||
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8 placements across 7 markets.
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8 placements across 7 markets.
