Send us a text In this Quality Grind Short by Medvacon, learn how to handle FDA 483 observations and warning letters effectively. We will guide you through the key steps in responding, emphasizing the importance of addressing systemic root causes, improving processes, and maintaining transparent communication with the FDA. Discover strategies for crafting a thorough response that demonstrates ownership and accountability, and learn how to turn compliance challenges into opportunities for stre...
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Send us a text In this Quality Grind Short by Medvacon, learn how to handle FDA 483 observations and warning letters effectively. We will guide you through the key steps in responding, emphasizing the importance of addressing systemic root causes, improving processes, and maintaining transparent communication with the FDA. Discover strategies for crafting a thorough response that demonstrates ownership and accountability, and learn how to turn compliance challenges into opportunities for stre...
Navigating Cell & Gene Therapy: The Quality Path to a Bright Future
Quality Grind Podcast
38 minutes
1 month ago
Navigating Cell & Gene Therapy: The Quality Path to a Bright Future
Send us a text In this episode of the Quality Grind Podcast, hosts Joe Toscano and Mike Kent conclude their four-part series on Cell and Gene Therapy with guest Ray Kaczmarek. They discuss the importance of building relationships and implementing solid quality systems across the development lifecycle. Ray shares his pragmatic views on ensuring quality and compliance from early stages, the significance of robust training programs, and the future prospects of the Cell and Gene Therapy fie...
Quality Grind Podcast
Send us a text In this Quality Grind Short by Medvacon, learn how to handle FDA 483 observations and warning letters effectively. We will guide you through the key steps in responding, emphasizing the importance of addressing systemic root causes, improving processes, and maintaining transparent communication with the FDA. Discover strategies for crafting a thorough response that demonstrates ownership and accountability, and learn how to turn compliance challenges into opportunities for stre...
