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Track: QUALITY ASSURANCE & QMS
Denise DiGiulio
Head of Global Audit and Inspection Management
Genentech
West Chester, Pennsylvania, United States
Paul Edson
Vice President, J&J Regulatory Compliance
Johnson & Johnson
Newtown, Pennsylvania, United States
Michele Piepoli
Senior Quality Consultant
Johnson & Johnson
Johns Creek, Georgia, United States
Carmelo Rosa, PsyD
Division Director, Office of Manufacturing and Product Quality, OC, CDER
U.S. FDA
Silver Spring, Maryland, United States
Quality is a mindset that impacts everyone and every relevant decision we make. A quality mindset starts at the top with strong support from executive leadership and is embedded in all functions and actions. A modern quality system and risk management approaches help manufacturers to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations for drugs (2l CFR parts 210 and 211) on a continuous basis.
This session will explain why regulatory actions are taken and how regulators determine regulatory significance. An experienced quality professional will share her knowledge and experience in the remediation of several Consent Decrees and warning letters. The road to remediation has required systemic improvements in quality culture and quality systems. Insights into establishing and sustaining a culture of quality assurance (and thus CGMP compliance) will be explained by senior leadership from both the regulatory and industry perspective.
Presenter: Michele H. Piepoli – Johnson & Johnson
Regulatory Presenter: Carmelo Rosa, PsyD – U.S. FDA
Moderator: Denise M. DiGiulio (she/her/hers) – Genentech
Panelist: Paul Edson – Johnson & Johnson
Panelist: Michele H. Piepoli – Johnson & Johnson
Regulatory Panelist: Carmelo Rosa, PsyD – U.S. FDA