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 components of quality culture, including an emphasis on resolving issues constructively rather than avoiding them, the crucial role of trust, a shared commitment to quality, and holding each other accountable for outcomes.
» How leadership should exemplify and consistently reinforce quality values, impacting trust and openness within the organization.
» The challenges in sustaining a quality culture, which underscore the need for ongoing employee engagement and assimilating new staff into the existing culture.
» The fact that quality culture isn't static and must evolve with changing internal and external business environments.
Vincent is a distinguished expert in quality assurance and regulatory compliance with over 30 years of extensive experience in the life sciences industry. As the Founder and Managing Consultant of Practical Compliance Results, LLC, he specializes in inspection readiness, compliance, and quality systems, focusing particularly on medical devices and in vitro diagnostics (IVD).
His expertise includes the development, management, and auditing of quality systems to ensure adherence to both domestic and international regulatory standards. Vincent is known for his skill in building and leading effective quality and regulatory compliance teams, ensuring their operational excellence and sustained inspection preparedness.
With a background as an internal and supplier auditor, Vincent brings practical insights into FDA inspection techniques and a comprehensive understanding of quality system standards such as ISO 13485 and ISO 9001. His experience is extensive in the European and Global regulatory landscape, including the EU Medical Device Regulations. He also offers valuable expertise in collaborating with contract design and manufacturing organizations (CDMOs), ensuring products are designed and manufactured in compliance with global quality system requirements. His proficiency covers a wide range of areas, including FDA Regulations, Quality Assurance, Regulatory Compliance, Change Control, and FDA Readiness and Remediation.
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/