The FDA Group's Nick Capman sits down with Matt Lowe, Chief Strategy Officer at MasterControl, to discuss the opportunities and challenges of implementing AI in the life sciences industry. Discussion points include: AI Applications in Life Sciences: Matt outlines the broad spectrum of AI applications, from early-stage drug discovery to post-market analysis of customer feedback and adverse events. Risk-Based Approach to AI: Matt emphasizes the importance of applying a risk-based approach to AI implementation, similar to other processes in the life sciences industry. Low-Risk, High-Value Use Cas ..read more

The FDA Group's Nick Capman sits down with Eric Busenburg, President of Euro-American Worldwide Logistics, where he oversees GMP storage and international shipping solutions for life science manufacturers. They discuss the critical challenges and solutions for storage in the life sciences industry, particularly for manufacturers experiencing rapid growth. Discussion points include: Understanding Storage Challenges: Eric explains the common storage issues that arise as life science manufacturers grow, including unexpected large orders and fluctuating production demands. Evaluating Storage Optio ..read more

The FDA Group's ⁠Nick Capman⁠ sits down with ⁠Aaron Snyder⁠, the Vice President of Quality Assurance at Allotex, where he oversees the development and implementation of quality systems for medical devices and pharmaceuticals. They discuss the critical elements of building and leading a successful QA team in the life sciences industry. Discussion points include: Recognizing the Need for Change: Aaron explains how to identify early signs of strain in the quality system and the importance of transitioning from a small to a larger, more structured QA team to support business growth. The Interview ..read more

The FDA Group's Nick Capman sits down with Tagg McGurrin, who most recently served as the President and Chief Business Officer (COO/CFO) at Neumentum, Inc., where he led corporate strategy, capital markets, corporate financing, accounting, legal, investor relations, and business development. They discuss the critical elements of planning, governance, and capital access necessary to build a strong foundation for a pharmaceutical startup in today’s economic environment. Discussion points include: Access to Capital: Tagg emphasizes the crucial role of securing capital in starting a pharmaceutical ..read more

The FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality management systems, and regulatory affairs, with a recent focus on AI in the dental diagnostic market. Discussion points include: The Regulatory Landscape for AI in Dental Diagnostics: Adam shares his insights on how AI and ML are becoming integral in dental diagnostics, aiding in identifying previo ..read more

The FDA Group's Nick Capman sits down with Nick Klingensmith, a four-time cancer survivor, motivational speaker, and mindset coach. They discuss the challenges of remote work, especially the disconnect between leadership, management, and frontline employees, and how it affects company culture and employee engagement. Key points discussed include: Klingensmith's journey from sales in the telecom and logistics industries to becoming a motivational speaker and coach, emphasizing resilience and overcoming obstacles. The fundamental disconnect in remote work environments, where leaders fail to eng ..read more

The FDA Group's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries. Discussion points include: The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manuals or SOPs in a timely manner. The complexities and confusion surrounding QMS integration post-merger or acquisition, emphasizing the importance of clear SOP adherence and SME identification. The strate ..read more

The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance. Discussion points include: The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance. The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors. Donna’s three components of a qualit ..read more

The FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise. Discussion points include: » The essence of quality culture being more than just adherence to procedures. It encompasses the actions, mindsets, and execution methods of employees—areas that are pivotal for inspection readiness and regulatory compliance. » The integral compon ..read more

The FDA Group's CEO, Nick Capman, sits down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections. Jonathan is an experienced healthcare industry executive with a proven track record in startups and Fortune 500 companies. He has a strong background in international QA/RA, engineering, and project management, specifically with medical devices, electronic assemblies, and supply chain management. Discussion points include: » The importance of a robust QMS and the role of third-party audits in ensuring unbiased compliance assessments, and preemptively identifyi ..read more