What to do if you are told by the Agency that your response to the FDA 483 is inadequate
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Hear By Elvia J. Cervantes Ex FDA Investigator has over 32 years of experience working for the Food and Drug Administration"
Firm should assess the 483 issued
The adequacy of a firm's response may prevent additional action being taken by the FDA. Having worked on various FDA initiated actions, I have observed firms submit responses that lacked detail and supporting evicence in support of corrective actions. There have been times where it is determined through further discussion with the firm that adequate corrections were taken however, they were not described fully in the response.
Why Should You Attend:
I will explain the type of information, detail and documented evidence the FDA expects when responding to a FDA 483 Inspectional Observations form. The FDA needs to have enough information in order to assess a firm's corrective actions. If the information provided by a firm is not sufficient or doesn't contain enough detail for the FDA, the Agency may take additional regulatory actions against a firm including but not limited to a Warning Letter.
I will explain how a firm should assess the 483 issued to them and discuss examples of what should be provided to the FDA in their response to the FDA 483 and what types of documentation should accompany the response and significance of responding in a timely manner.
And much more !
Who will Benefit
• Compliance Staff
• Quality Control Staff
• Production Staff
• Compliance officers
• Regulatory affairs officers
• Clinical affairs personnel
• Quality assurance officers
• R&D personnel
• Anyone interested in the FDA regulatory pathways for new drugs and generics
Industries who can attend
FDA Regulated industry: Pharmaceutical,Medical Device, Human Tissue, Food, Dietary Supplement, Biologics, etc.