Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. This is important for all methods used in all FDA and equivalent international environments. While the USP and ICH guidelines are well accepted as standards for validation of routine analytical methods used in quality control development laboratories are unsure on what and how much to validate. However FDA inspectors go out and write inspectional observations and warning letters, for example: "The Study Director failed to ensure that analytical methods used in nonclinical laboratory studies were accurate.". So there are many questions. In this seminar attendees will learn how to validate analytical methods for GLP and GCP studies. During the seminar, the speaker will present cost-effective validation strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation.
Areas Covered in the Seminar:
* FDA references with request for method validation used in GLP and GCP studies
* European and international references
* Examples of warning letters and how to avoid them
* The concept and implementation of validation by development phases
* The purpose of validation and use of methods in different phases
* Parameters that should be tested for preclinical studies and for clinical studies phases I, II and III.
* Defining test conditions and acceptance limits for each phase
* Using the risk based approach for short and long term studies
* Seven most common method validation pitfalls and how to avoid them
* Using software for automated method validation
* Sharing best practices
* Documentation for the FDA and for other agencies
And for easy and instant implementation:
download 10+ documents from special seminar website.
They include
* 70 page primer: Validation of Analytical Methods
* SOP: Validation of Bioanalytical Methods
* SOP: Validation of Chromatographic Methods
* SOP: Validation of Stability Indicating Methods
* SOP: Change versus Adjustment of Compendial Methods
* Template/Checklist:
* Example: Detailed Validation Report
* Reference Article: Validation of Analytical Methods: Review and Strategy
* Five Warning letters and/or Inspectional observations related to method validation, includes examples from GLP studies
* *FDA Guidance : Bioanalytical Method Validation
* FDA Guidance: Analytical Procedures and Methods Validation (draft)
* EMA Guideline on Bioanalytical Method Validation
* FDA presentation:
* ICH Guidelines for the Industry Q2 (R1): - Text and Methodology on Validation of Analytical Procedures
Date: November 29, 2012
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide
Who should attend
* (Bio) Pharmaceutical and API Industry
* Clinical Research Organizations
* GLP development laboratories
* Study directors
* QA managers and personnel
* Analysts and lab managers
* Validation specialists
* Training departments
* Documentation department
* Consultants
Weblink: http://www.labcompliance.com/
Category: Pharmaceutical, Clinical Research Oragnisations, FDA, Training, Stabilty testing, Laboratories, Medical devices, Contract Laboratories
Presenter: Dr. Ludwig Huber
Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory)
