System Suitability Testing for FDA Compliance - By Dr Ludwig Huber

Website https://compliance2go.com/product/?topic=system-suitability-testing-for-fda-compliance-by-dr-ludwig- | Edit Freely

Category Biotechnology , Pharmaceutical

Deadline: July 15, 2015 | Date: July 15, 2015

Venue/Country: Online, U.S.A

Updated: 2015-06-29 17:25:47 (GMT+9)

Call For Papers - CFP

System suitability testing (SST) is required by USP and FDA to check and ensure on-going performance of analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and other agencies. 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 makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. This seminar will give a good understanding of FDA and USP requirements for system suitability testing

Topics:

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

Recommendations for implementing the new

Developing an SOP for system testing

Criteria for SST timing within a sequence of sample runs

The role of SST for method changes according to the new chapter .

Recommendations for non-chromatographic systems

Case studies with practical advice for test parameters and limits

Recommendations for non-chromatographic systems

Documenting SST test runs

Who will benefit:

Analysts

Lab supervisors and managers

QA managers and personnel

Quality control laboratories

Analysts

Teachers

From

Pharmaceutical industry

API manufacturers

Contract laboratories

Consultants

Hand-outs:

For easy implementation, attendees will receive

SOP: System Suitability Testing in Chromatography

Example protocols for Occasional and Ongoing System Suitability Tests

Checklist: System Suitability Testing

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

75 Minutes Live Presentation

Certificate of Attendance