2011 - Validation of Analytical Methods and Procedures

This seminar will discuss how to design, conduct and document validation of analytical methods for FDA compliance.

Why to attend:

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. This seminar will discuss FDA and equivalent international requirements and provide several Warning Letters for non-compliance. This seminar will go through all steps on how to design, conduct and document method validation experiments for efficiency and compliance. Attendees will receive a toolkit with SOPs, Case Studies and Examples for easy implementation.

Areas Covered in the Seminar:

* FDA regulations and guidelines
* Examples of warning letters and how to avoid them
* USP Chapters and ICH Guides
* Developing an SOP for method validation
* Development of a validation plan for success
* Prerequisites for method validation
* Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
* Defining test conditions and acceptance limits
* Verification of compendial methods
* To revalidate or not after method changes
* Transferring a method to routine
*?Seven most common method validation pitfalls and how to avoid them
* Documentation for the FDA and for other agencies

Date: December 8,2011
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide (oder USA, nicht Germany, fall das möglich ist)

Who should attend
* (Bio) Pharmaceutical and API Industry
* Food, environmental, clinical, and chemical testing laboratories
* QA managers and personnel
* Analysts and lab managers
* Validation specialists
* Training departments
* Documentation department
* Consultants

Weblink: http://www.labcompliance.com/seminars/audio/280/de...

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, FDA, validation