Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, corresponding with FDA, and handling 483s can be even more significant.
Lachman Consultant Services, Inc. (Lachman Consultants) newest webinar, “How to Respond to Inspectional Observations,” will take place on Thursday, May 21st from 2:00 pm to 3:00 pm EDT, and provide you with up-to-the-minute advice and insights that will help your organization respond to the FDA findings and queries that inevitably follow an inspection.
This second installment of the ongoing webinar series will be hosted by Ricki Chase, former FDA Director of the Investigations Branch in the Chicago District. Joining her will be Linda Evans O’Connor, Vice President, Chief of Staff, Lachman Consultants.
Included in the subjects presented during this comprehensive one-hour event will be an overview of FDA-483, the steps included in formulating a response, the elements of a good response, and things to avoid when developing a response. Among the points addressed for establishing Corrective and Preventive Actions (CAPAs) will be an overview of CAPAs, the elements that comprise a robust CAPA, and the best methods for effectively implementing CAPAs.
Register for the “How to Respond to Inspectional Observations” webinar today.
For more information about Lachman Consultants’ webinars, visit Lachman Learning.