Why the course “Method validation – structure and design under ISO/GMP/GLP”?

What is involved in validating a method? That is the subject of this course. Modern quality management systems for control laboratories (such as, for example: ISO 17025, ISO 15189 and GLP/GMP), require working with validated analysis and testing methods. However, the quality standards do not describe how analysis and test methods can be validated.

In this course, you will learn how to set up validations according to the ICH guideline. Upon completion, you will have a clear understanding of the validation of analysis and test methods and will be able to set up and implement a validation plan for the methods in your own laboratory. Optionally, you can attend the additional day that deals specifically with HPLC methods. This course is closely related to the course Practical Statistics with Excel 2: for Method Validation, but can also be taken separately.

Who is this course intended for?

You have at least a college education or you are a college graduate with extensive experience. You are directly or indirectly involved in method validation and you want to know more about setting up and executing validation plans, collecting the necessary information and documenting validations.

Program.
The program over both days will cover at least the following topics:

Introduction and basic principle standards (including GMP/ ISO).

• Drug development and analytical method development
  Dossier
• GMP requirements for Quality Control
• Reagents and standards
• Sampling
• Testing
• Stability studies
• The primary process of the Quality Control Laboratory
• Data integrity (including GMP/ ISO).

Documentation

• Procedures and instructions
• Test methods and specifications
• Good Documentation Practise
• Paper versus electronic records
• Validation Master Plan
• Protocol and Report Validation – qualification – calibration
• Validation
• Qualification
• Calibration
• Other validations (process, cleaning, computerized systems)
• Relationship between equipment qualification and method validation
  Quality Management Systems
• Deviation management and OOS
• Change Control
• Analytical Method Transfer
• Analytical Method Validation
• Compendial Methods

Where to apply

• Guidelines (e.g. ICH Q2)
• Acceptance criteria
• Performance characteristics
• Revalidation
• System Suitability Test
• Equipment qualification

Precondition for analytical method validation
URS
Risk Management
Qualification tests
Equipment release
Use
Decommissioning
Methodology
In this course you will learn which aspects to pay attention to in validation and which not. With this knowledge you will prepare in workshops a validation plan of a simple test case or your own method. The draft plans are evaluated and adjusted during the course. With the gained new insights you can then validate the methods in your own practice. The instructor has extensive experience in designing and implementing validation protocols. He has also been teaching courses in that field for over 15 years. This course is closely related to the course Practical Statistics with Excel for Method Validation, but can also be taken separately.

The Result
Upon completion of this course, you will have a clear understanding of the various validation models. You will be able to set up and execute a validation plan, with appropriate documentation for each phase.

The diploma
After successful completion of this course, you will receive a certificate of participation.

Time inversion
This is a two-day course: November 6 and 13, 2019.

Financial investment.
The investment for the course is as follows:
Course fee € 1,290 (excluding 21% VAT).