Trainer Guide for
Method Validation H1184A
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Trainer Guide for
Method Validation H1184A
Guidline through Workshop
Guideline

Overview:
1. Prerequisites
2. Time schedule for the course
3. Detailed Information
4. Course Guide in Detail
5. Summery and useful hints
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Trainer Guide for
Method Validation H1184A
Guideline
Preparation
The student gets both manuals in printed form:
H1184A.doc and
MethodDocumentation-Example.doc
both of them are to be found in Postscript format on the CD under:
.\Postscript\H1184A_A4.ps
(A4 paper format)
.\Postscript\MethodDocumentation-Example_A4.ps
.\Postscript\H1184A_Letter.ps
(A4 paper format)
(US-Letter paper format)
.\Postscript\MethodDocumentation-Example_Letter.ps (US-Letter paper format)
Slides can be presented directly from the CD. Please use H1184A.ppt which
includes all slides.
For individual use of the material each presentation and module can be found
separately under .\ModXX\.
Prerequisites
Hardware :
One PC per two students.
Windows 95 or NT 4.0 or higher
MS Excel 97 installed, copy .\Data\ValidationStudentData.xls from the CD to
local disk and change file properties from read-only to read/write.
One PC for trainer with Windows95 or NT 4.0 or higher
For slide presentation an appropriate beamer/ LCD display for overhead projector
Trainer Skills:
Deep knowledge in LC and method development principles.
Understanding the pharmaceutical working enviroment and
regulation rules of GLP and ICH guidelines.
Familiar with MS Excel statistic tools.
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Trainer Guide for
Method Validation H1184A
Guidline through Workshop
Helpful literature and Web sites:
Ludwig Huber, Validation and Qualification in Analytical Laboratories,
Interpharm Press, Inc. Buffalo Grove, Illinois, ISBN: 1-57491-080-9 (1999)
EUROACHEM working group, The Fitness for Purpose of Analytical Methods,
LGC, Queens Rd., Teddington, Middlesex, TW11 0lY, UK, ISBN: 0 948926 12 0
(1998)
Validation of analytical procedures : methodology (ICH), MCA EuroDirect
Publication No.281/95, http://www.vtt.fi/ket/eurachem/
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Trainer Guide for
Method Validation H1184A
Guideline
Time schedule for the course:
1st Day
 Introduction Lecture
 Validation Overview
-
What is Validation
-
Why Validation
-
What has to be validated
-
Regulation Overview
-
Regulation Terminology
 How to do…………Scenario
-
Example method introduction
-
Scope/purpose of the method
-
Definition of Performance Criteria
2nd Day
 Parameters for Method Validation
 System Suitability
 Summary
Detailed Information:
This training is a lecture workshop style of training.
The workshops are based on an analytical HPLC method
"Determination of MEVA Content in Bulk Material" and the data
are summarized in an MS Excel worksheet.
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Trainer Guide for
Method Validation H1184A
Guidline through Workshop
Two different worksheets are available, one for the trainer includes
all results with notes (!), one for the student without results.
They are to be found on the CD-ROM under
.\Data\ValidationStudentData.xls
.\Data\ValidationTrainerData.xls
All necessary calculation can be done in MS Excel.
Course Guide in detail
Validation Overview
The aim is to give the student an answer for the question:
- What is Validation
- Why Validation
- When should be valiated
- What has to be validated
- Difference between
Test/Verification/Calibration/Qualification
- Method Validation Parameter
Scenario for this part of the course reflecting a real situation in a lab
- The example "Determination of MEVA Content in Bulk
Material" is introduced with the acceptance criteria, the
equipment performance, qualification of used materials etc.
- The full separation method is described in Appendix A.
The goal for this session is to workout based on the example method
the first planning steps of the method validation plan in workgroup(s).
The student should afterwards be familiar with the scenario and the
example method.
The student should be able to understand the first planning steps for
method validation.
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Trainer Guide for
Method Validation H1184A
Guideline
The example method is used to demonstrate the results of the first
planning steps.
Parameters of Method Validation Parameter
This part is a mixture of lecture and workshop.
Each topic is divided into lecture explaining the definition and the
practical approach. The second part is the workshop part.
For each topic a set of raw data is provided on MS-Excel.
The aim of the workshop is to learn how to calculate the necessary
results and compare it to the acceptance criteria. How the results are
supporting the issue of that validation steps.
Explain the meaning of each parameter to the method.
!!It seems to be very important to spend few minutes to discuss the
results and the meaning of the result numbers for the method!!
Implementation and Usage of a Validated Method
This small lecture provides the necessary information, how to transfer
and use a validated method. The student should clearly understand the
requirements in the introduction of a validated method in a different
lab.
System Suitability
This is a lecture part and provides the basic knowledge of daily use of
a method and the nessecary suitability tests.
The part includes an example for discussion based on given example
method. The part "Short Term Stability" in the data set for the trainer
can be used as an example.
Method Documentation - Example
Separated from the course manual there is an "Method Documentation
Example". It is a full method and validation document.
It should be used to summarize the course topics.
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Trainer Guide for
Method Validation H1184A
Guidline through Workshop
For this part, it might be necessary to spend an hour inclusive a Q/A
session.
Summary and useful hints:
The course concept is to mix theoretical with practical steps.
It could be critical to stay focused on the course structure and do not
get lost in the Q&A session
Feedback to:
Herbert Klejna,
SSD, Hewlett-Packard Vienna, Telnet 781-6495,
email: herbert_klejna@.hp.com
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