System Suitability Testing for FDA and USP Compliance

June 26, 2013 - PRLog -- Why to attend:

System suitability testing (SST) is required by USP and FDA to check and ensure on-going performance of a analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation.  Also, the USP chapter <1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. So there are many questions. This seminar will have the answers. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs and checklist will help immediate and cost effective implementatio.

Areas Covered in the Seminar:

* FDA and International requirements for system suitability testing
* Examples of FDA warning letters and how to avoid them
* The role of SST for analytical quality assurance
* SST in comparison with equipment qualification and quality control sample analysis
* Most critical parameters for SST in EP and USP
* Contents of the updated USP chapter 621
* Recommendations for implementing the new 621
* Developing an SOP for system testing testing
* Criteria for SST timing within a sequence of sample runs
* The role of SST for method changes according to the updated chapter 621
* Criteria for revalidation for method changes
* Case studies with practical advice for test parameters and limits
* Documenting SST test runs

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* SOP: System Suitability Testing in Chromatography
* SOP: Change Versus Adjustment of Compendial Methods
* Examples: Protocols for Occasional  and Ongoing System Suitability Tests
* Examples: Performance Qualification for HPLC
* Checklist: System Suitability Testing
* Checklist: Laboratory Audits
* FDA and USP Presentations on method validation and System Suitability Testing
* Five Warning letters and/or Inspectional observations related to SST suitability testing
* PowerPoint Presentation
* Script of the presentation
* All questions and answers from before, during and after the seminar


Date:  Sptember 5, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Who should attend
* (Bio)Pharmaceutical, Device and API Industry
* QA managers and personnel
* Analysts and lab managers
* Validation specialists
* Training departments
* documentation department
* Consultants


Weblink: http://www.labcompliance.com/seminars/audio/320/default.aspx