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/
* 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
Weblink: http://www.labcompliance.com/
Presenter: Dr. Ludwig Huber
Category: Pharmaceutical, Device Manufacturer, FDA, inspections
