Événement
One Day Seminar: "Effective Responses to FDA-483 forms and Warning Letters
DESCRIPTION
Seminar Description
FDA has increasingly issued FDA-483 Observations and then turned to Warning Letters as a tool for voluntary compliance. Unfortunately, the types of issues FDA is including in FDA-483s and Warning Letters makes mere compliance not sufficient, but rather the company must have state of the art quality systems. It is no longer sufficient to have a procedure and follow it. FDA may consider the procedure inadequate and evidence you follow the procedure may not be acceptable to FDA as you may have not done it up to the FDA requirements. Effective responses to FDA-483 Observations can prevent a Warning Letter, and effective responses to Warning Letters can prevent the famous Sign or Sue Letter from FDA (the infamous consent decree).
In this seminar, we will discuss the kinds of issues FDA is citing on FDA483s and in Warning Letters relating to quality system deficiencies. We will discuss inadequate responses and the FDA consequences for such. We will discuss how to prepare a response FDA will consider acceptable and prevent further FDA actions.
Finally, we will discuss how to establish quality systems that will be acceptable to FDA and avoid FDA-483a and Warning Letters.
Your instructor has held almost every field position within FDA during his 21-year career with FDA, Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years experience in the Medical Device industry rising from an RA Manager to being a Vice President of RA/QA/Clinical for major class 3 device manufacturers.
Seminar Objectives:
Become familiar with issues that are in FDA 483s and Warning Letters
Know what kinds of response will not be acceptable to FDA
Know how to effectively respond to an FDA 483 or Warning Letter
Know what kinds of company actions can avoid Warning Letters
Know how to negotiate with FDA to effectively close Warning Letters
Who should attend this Seminar?
VPs,
Directors,
Managers
Regulatory Affairs
Quality Assurance
Internal GMP Auditors
Consultants
who assist firms with FDA 483 response and Warning Letter remediation.
Seminar Agenda
8:30 AM - Opening Introductions
8:45 AM - Seminar Goals and topics to be discusses.
9:00 AM - FDAs legal authority and how they use it. The FDA Inspection, Legal Actions
10:30 AM - Break
10: 45 AM - The FDA-483, What it is, and how to handle it.
12:00 PM - Lunch
1:00 PM - FDA Warning Letters Why are they issued, how are the used, how to respond
1:45 Participant Exercise Creating Effective Response.
Create responses to typical FDA-483 Observations and Warning Letter Citations
2:30 Break
2:45 - Review and critique participants responses.
4:00 PM Summary of the day, Questions & Answers
4:30 PM Adjourn
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AdresseHilton Garden Inn Boston Logan Airport (Afficher)
100 Boardman Street
Boston, MA 02128
United States
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