FDA Insider Secrets - All You Need To Know To Avoid A Warning Letter [Luis Charles Chavarría]
Listen now
In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really operates, their main purpose during an audit, and sheds light on details you have probably never known about the FDA.  Who Is Luis Charles Chavarría? Luis has served in FDA for about three decades in several capacities that have earned him an unprecedented understanding of FDA affairs. He is currently working as President/Lead Consultant at Supaso International. He has also worked with the US Department of Justice and contributed to policymaking at the national as well as on the international level. Reading the Article and Listening to the Podcast, You Will Learn About: ● What Does an FDA Agent Do? ● Difference Between an FDA Investigator and a Regular Quality Auditor ● Evidence Development by an FDA Investigator ● Procedures for Foreign-Based Manufacturing Units ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at www.podcast.qualistery.com/guide-to-preparing-yourself-for-an-fda-audit/ ------------------------------------------------------------------------------------------------------ This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
More Episodes
In this episode of the Qualitalks Podcast, we are honoured to have Toon Lambrechts as our guest. Toon is a self-proclaimed biotech nerd with an impressive background in the field of advanced cell and gene therapies. In this episode, we’ll dive into Toon’s passion for democratizing access to...
Published 06/20/23
Published 06/20/23
In this podcast episode, Nathan Roman joins us to discuss the importance of temperature-controlled transport and the two types of storage solutions: active and passive. He explains that the cold chain includes all food, medicine, drug products, and vaccine-related equipment and procedures....
Published 03/29/23