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

The FDA Group's CEO Nick Capman, sits down with Sunil Gupta, a seasoned expert in pharmaceutical data, to shed light on the nuances of SDTM (Study Data Tabulation Model) compliance and its pivotal role in clinical trial processes. Sunil brings a wealth of experience from his three decades in the pharmaceutical industry, focusing on areas like SAS programming, submissions, and leveraging new technologies for clinical trials. Discussion points include: » The transition from manual processes to technology-enhanced procedures in clinical trials — specifically the shift towards automation and ..read more

The FDA Group's CEO Nick Capman, sits down with David Marks to discuss the intricacies of Quality culture and QA communication pathways in the life sciences. David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs. Discussion points include: » The crucial role of a Quality culture, especially in biopharma and clinical settings. David discusses how a strong Quality culture leads to proactive organizations, reducing the frequency of a ..read more

The FDA Group’s CEO, Nick Capman, sits down with Paul Hakamaki, Vice President of Quality at Anteris Technologies, to explore the nuances of supplier management in the medical device industry. Discussion points include: » Paul's journey from a supplier quality engineer to Vice President of Quality and his experience across various company sizes in the medical device sector. » The critical importance of supplier management in the medical device industry, highlighting the necessity for clear expectations, risk management, and fostering partnerships beyond mere transactional relationships. » A sp ..read more

The FDA Group’s CEO, Nick Capman, sits down with William V. Williams, MD, FACP, President and CEO of BriaCell Therapeutics Corporation, a company at the forefront of developing personalized cell therapies and immunotherapies for cancer. Dr. Williams reveals the current landscape and future potential of cancer treatments, focusing on the role of immunotherapies and cell therapies in revolutionizing patient care. Discussion points include: » Dr. Williams's extensive background in drug development and his transition to leading BriaCell Therapeutics Corporation. » The significant unmet needs in ca ..read more

The FDA Group’s CEO, Nick Capman, sits down with Jessica Smith Beaver, PhD, President & CEO of Verinetics, to explore various career trajectories within the quality and regulatory space in the life science industry, the advantages and challenges of different paths, and the crucial role of personal reflection in career development. Discussion points include: » Dr. Beaver's journey from a pharmacist to a contributing scientist in the pharmaceutical industry, and her eventual transition into regulatory affairs and quality space. » The dilemmas faced by professionals in RA/QA roles, such as th ..read more