Validation of Analytical Methods and Procedures

Website http://www.labcompliance.com/seminars/audio/280/default.aspx | Edit Freely

Category Pharmaceutical; FDA; validation

Deadline: December 08, 2011 | Date: December 08, 2011

Venue/Country: Virtual, U.S.A

Updated: 2011-09-08 19:52:15 (GMT+9)

Call For Papers - CFP

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/default.aspx

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, FDA, validation