System Suitability Testing for FDA and USP Compliance training seminars presented by Online Compliance Panel register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

System Suitability Testing for FDA and USP Compliance  

 Email information about this seminar System Suitability Testing for FDA and USP Compliance by Online Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like System Suitability Testing for FDA and USP Compliance by Online Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Online Compliance Panel on FindaSeminar.com Other seminars from Online Compliance Panel

By:

Online Compliance Panel   

For:

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

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 <1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. This webinar will give a good understanding of FDA and USP requirements for system suitability testing. (see full course description)

 

 Seminar / Training class dates & locations

 
 SORT RESULTS BY:

 DATE

LOCATION

SELECTED VENUE DETAILS

Facility Name: 
Address:





Registration Information:

Event cost:  $
USD

class times and cancellation policy

 
 




 From 
 To 
 Click to register by Register by fax for System Suitability Testing for FDA and USP Compliance training seminar Register by mail for System Suitability Testing for FDA and USP Compliance training seminar Register by phone to attend System Suitability Testing for FDA and USP Compliance training seminar

Print payment approval request form System Suitability Testing for FDA and USP Compliance training seminar

Pre-Registration questions? Find answers in our registration FAQ or Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request

 
 

 

share this page 

print the agenda print agenda for the System Suitability Testing for FDA and USP Compliance seminar

 

 

Training Course Syllabus:


System Suitability Testing for FDA and USP Compliance

Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: Dr. Ludwig Huber


Description:

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 <1058> makes a statement that SST can substitute an instrument´s performance qualification, but not further guidelines are given. This webinar will give a good understanding of FDA and USP requirements for system suitability testing.

Why Should you Attend:

Attend this session to understand more on FDA and USP requirements for system suitability testing explained with the help of case studies and gain practical advice for test parameters and limits.

Objectives of the Presentation:

This training on Credit Card Program Benchmarking will cover the following areas:


  • 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

  • Criteria for SST timing within a sequence of sample runs

  • The role of SST for method changes according to the new chapter 621

  • Recommendations for non-chromatographic systems

Who can Benefit:


  • Laboratory managers and supervisors

  • Quality Assurance Managers

  • Develops of spreadsheet applications

  • All users of Excel used in regulated environments

  • QA managers and personnel

  • GMP auditors

  • Consultants

Seminar Summary:

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 <1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. This webinar will give a good understanding of FDA and USP requirements for system suitability testing. (see full course description)

print this agenda print agenda for the System Suitability Testing for FDA and USP Compliance training seminar

 view dates and locations for this seminar

 

 

 

Custom Search