Hardware Podcasts

066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio

Let's Combinate · 4 Jan 2023 · 55m

What this episode covers

Fran DeGrazio, President of Strategic Parenteral Solutions and former Chief Scientific Officer at West Pharmaceuticals, discusses the complexities of combination products, highlighting the historical silos between science and engineering. She explains how regulatory frameworks like ICH Q8-Q10 and Quality by Design (QbD) have shifted the industry toward risk management and lifecycle management, which she identifies as a major struggle for smaller organizations. DeGrazio also shares her career trajectory at West, detailing her transition from laboratory roles to leading Quality, Regulatory, and Marketing, emphasizing the importance of strategic execution and continuous learning.

Most relevant to

large enterprises and early-stage companies

Topics

Mentioned

Companies
West Pharmaceuticals, Strategic Parenteral Solutions
Also
ICH Q8, ICH Q9, ICH Q10, TCS, Good to Great

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 35m

    #467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

    Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), explains the regulatory complexities of combination products, focusing on how the Primary Mode of Action (PMOA) dictates FDA oversight. He details the challenges pharmaceutical companies face when integrating device Quality Management Systems (QMSR/ISO 13485) into their existing CGMP frameworks under 21 CFR Part 4. The discussion covers specific friction points like risk management alignment (AAMI TIR105 vs. ICH Q9), labeling classifications, and the critical need for transparent change control protocols between device manufacturers and pharma partners.

    Certification & complianceDesign for manufacturing & NPI
    8 chapters

  • Global Medical Device Podcast · 42m

    #323 The Combination Products Handbook

    Susan Neadle, principal consultant and president of Combination Products Consulting Services, discusses her peer-reviewed book, The Combination Products Handbook: A Practical Guide, published by CRC Press. Neadle explains how she collaborated with FDA officials, including John Barwiener, and industry experts from companies like Johnson & Johnson, Novartis, and Pfizer to create a consolidated resource for the complex niche of combination products. The episode details the book's structure, covering regulatory strategies, CGMPs, risk management, and human factors, while highlighting the challenges of harmonizing terminology between pharmaceutical and medical device sectors. Neadle emphasizes the importance of holistic thinking and integrated development to ensure patient safety and regulatory compliance across global jurisdictions.

    Medical & health devicesCertification & compliance
    9 chapters

  • Global Medical Device Podcast · 38m

    #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He explains the definitions of single entity, co-packaged, and cross-labeled products, and addresses common misconceptions about the differences between drug and device quality systems. Saadeh also shares his journey of starting the podcast to maintain consistent learning and production, highlighting the importance of lifelong learning and leveraging coaching to balance technical and business aspects of the MedTech industry.

    Medical & health devicesCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 50m

    #440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former VP of Quality at Medtronic and Boston Scientific, discusses the evolution of quality and regulatory roles in the medical device industry. She emphasizes that quality professionals must act as strategic influencers and project managers, using storytelling to connect compliance requirements with business outcomes like cost of poor quality. The conversation covers the importance of human factors in design, the nuanced concept of 'design freeze', and the necessity of proactive quality management to ensure patient safety and regulatory agility.

    Leadership, teams & cultureMedical & health devices
    5 chapters

  • Global Medical Device Podcast · 50m

    #352: Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former quality leader at Medtronic, Boston Scientific, and Johnson & Johnson, discusses the strategic role of quality and regulatory professionals in the medical device industry. She emphasizes that effective quality management requires strong project management skills, proactive stakeholder influence, and a deep understanding of human factors to prevent post-market failures. Mascioli-Tudor also advocates for building a culture of psychological safety and continuous improvement, arguing that quality teams must act as business partners rather than just compliance police.

    Leadership, teams & cultureValidation & product-market fit
    7 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.