April-Warning Letter Wednesday (WLW)

​Join us for Warning Letter Wednesday! A focused hour reviewing recent FDA Warning Letters, trends, and key takeaways for quality and regulatory teams at life science companies.

Every response to an FDA-483 and Warning Letter typically includes the submission of proposals known as CAPAs (Corrective and Preventive Actions). These CAPAs may involve corrections, corrective actions, preventive actions, and improvement activities.

GKS will provide a comprehensive overview of how companies should design, document, implement, close, and verify the effectiveness of CAPAs in response to FDA concerns. Feel free to invite colleagues and friends who may not have access to this notification.

​​​Guest Speakers:

​Daniel Barreto, President and Owner of PharmQ Global Consulting, LLC. Established in 2020, PharmQ specializes in providing strategic, operational, and tactical consulting services to clients in the pharmaceutical industry.

​​Dr. Ligia Zubik, Director of Quality at Global Key Solutions, has over 20 years of experience leading regulatory compliance and inspection readiness at major pharmaceutical companies.

​​Topics covered:

• ​How Corrective and Preventive Actions(CAPAs) play into 483 and Warning Letter Responses

• ​How companies should design, document, implement, close, and verify the effectiveness of CAPAs