2012 - 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
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
Weblink: http://www.labcompliance.com/seminars/audio/289/de...
Presenter: Dr. Ludwig Huber