Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
The Life Science Rundown
by The FDA Group
5d ago
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
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Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
The Life Science Rundown
by The FDA Group
2w ago
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
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A Blueprint for Quality Culture with Vincent Cafiso
The Life Science Rundown
by The FDA Group
2M ago
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
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An FDA Inspection Survival Guide with Jonathan Wacks
The Life Science Rundown
by The FDA Group
2M ago
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
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Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta
The Life Science Rundown
by The FDA Group
2M ago
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
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The Link Between Quality Culture and QA Communication Pathways with David Marks
The Life Science Rundown
by The FDA Group
3M ago
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
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Mastering Medical Device Supplier Management with Paul Hakamaki
The Life Science Rundown
by The FDA Group
3M ago
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
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Personalized Cell Therapies and the Next Frontier in Oncology with Dr. William V. Williams
The Life Science Rundown
by The FDA Group
3M ago
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
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Growing Your Career in RA/QA with Jessica Smith Beaver, PhD
The Life Science Rundown
by The FDA Group
4M ago
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
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Drug Delivery System Innovation and Leadership with Steve Knowles
The Life Science Rundown
by The FDA Group
4M ago
The FDA Group’s CEO, Nick Capman, sits down with Steve Knowles, MB.BS, M.R.C.P., M.F.P.M., Chief Medical Officer at Halozyme, a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. They discuss advancements in drug delivery technology and the role of leadership in fostering innovation and addressing challenges in this field. Discussion points include: » Dr. Knowles's transition from a physician in the UK to Chief Medical Officer at Halozyme in San Diego. » The evolution in drug delivery systems ..read more
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