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

Description

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.    

Areas Covered

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

•        Manangers 
•        Compliance Staff 
•        Quality Control Staff 
•        Production Staff
•        CEOs
•        VPs
•        Compliance officers
•        Attorneys
•        Regulatory affairs officers
•        Clinical affairs personnel
•        Quality assurance officers
•        R&D personnel
•        Consultants
•        Contractors/subcontractors
•        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.


Speaker Profile

Elvia J Cervantes

Elvia J. Cervantes Ex FDA Investigator has over 32 years of experience working for the Food and Drug Administration, with demonstrated record of accomplishments inspecting various manufacturing operations in both the domestic and import arena. Oversight of multiple regulatory cases which resulted in proven results of evidence development and application of law, to prevent dangerous products from reaching the consumer or removal of dangerous products from the marketplace. Proven leadership throughout my career as a FDA Investigator, Compliance Officer and Supervisor, resulting in proven record of accomplishments.

Served as Level 1 Auditor for Dallas District and also Training Coordinator for new FDA Investigators. Provided classroom training as well as on the job training.

Throughout my career, I trained FDA Investigators, state investigators and foreign counterparts across multiple regulated commodities including but not limited to food, human tissue, bio research monitoring, medical devices and drugs.

Served a detail at the FDA Mexico City office providing outreach and support to Mexican industry personnel as well as Mexican government officials.

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