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FDA 483 Responses: Avoiding Common Pitfalls and Deficiencies (Ep. 8 of The Pharmcast)
This week on The Pharmcast, we talk with Judith Meritz, J.D. (Former Associate General Counsel at Covidien/Medtronic), and Victor Chance (Former Vice President of External Operations and Chief Supply Chain Chief Procurement Officer for J&J Medical Devices and Diagnostics), as they outline the most frequent deficiencies cited in a FDA 483 as well as highlight common pitfalls in the supply chain function when addressing compliance remediation issues.
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By YourEncore, Inc.This week on The Pharmcast, we talk with Judith Meritz, J.D. (Former Associate General Counsel at Covidien/Medtronic), and Victor Chance (Former Vice President of External Operations and Chief Supply Chain Chief Procurement Officer for J&J Medical Devices and Diagnostics), as they outline the most frequent deficiencies cited in a FDA 483 as well as highlight common pitfalls in the supply chain function when addressing compliance remediation issues.