How to Survive FDA's 'New' Inspection and Enforcement Practices

This seminar will discuss how FDA did change inspection practices and how to respond to avoid 483s and Warning Letters
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Listed Under

* Pharmaceutical
* Device Manufacturer
* Fda
* Inspections

* Medical
* Education

* US

April 12, 2012 - PRLog -- Why to attend:
FDA inspections and enforcement recently have become much more aggressive  Just a few facts: in 2011 FDA has increased the budget for manufacturing plant inspections by 30% to $135M$, in the same period the number of  warning letters increased by 155%, shipment holds and multiple product recalls have been announced even for global players, one company had to pay 500 M$ fine as a result of failed inspections, and inspectors ask for details they never did before. The only way to survive the new practices is to get accurate, up-to-date information on the new inspection practices and to prepare your organization accordingly.        

Areas Covered in the Seminar:

*  Inspection process for API, drug manufacturing and device manufacturing
*  Recent changes: summary and details
*  10 Examples of recent observations/deviations that came as a surprise
*  Strategy to respond to the 'New' type of inspections
*  Case study: Going through a typical inspection process
*  Preparing your staff for the 'New' FDA inspections
*  Conducting 'FDA inspection like' internal audits
*  Tips how to respond during inspections to avoid inspectional observations
*  The role of the Exit Meeting to avoid enforcement
*  Developing a corrective action plan with identification of the root case
*  Developing a detailed preventive action plan to avoid reoccurrence
*  How to use all this information for all national and international inspections
Date:  April 26,2012
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide

Who should attend
*   QA managers and personnel
*   QC directorsAnalysts and lab managers
*   Regulatory affairs
*   Internal auditors
*   Training department
*   Documentation department
*   Consultants


Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, Device Manufacturer, FDA, inspections
Source:Dr. Ludwig Huber
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