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ICH Q2(R2) and ICH Q14


Analytical validation, ICH Q2, ICH Q14, Quality R&D, QC, CMC, RA

 

•    Understand the differences between ICH Q2(R1) and ICH Q2(R2)

•    Become acquainted with the new ICH Q14

•    Understand the validation strategy for different analytical techniques as described in the examples in ICH               Q2(R2) 

The draft ICH Q2(R2) and ICH Q14 guidelines have been published for public consultation. Together, ICH Q14 and ICH Q2(R2) describe the development and validation activities suggested during the lifecycle of an analytical procedure used for the assessment of the quality of drug substances and drug products.
This 4-hour course provides an overview of the contents of ICH Q14 and the revised ICH Q2. In more detail, it is discussed how the two guidelines complement each other and fit into the landscape of other ICH guidelines. The analytical lifecycle concept as presented in ICH Q14 is explained. The differences between ICH Q2(R1) and the proposed R2 of ICH Q2 are presented. The course encompasses the discussion of various examples for the analytical method validation of analytical techniques as proposed in the annexes of draft ICH Q2(R2). 

This course has been developed for analytical (R&D) and QC personnel involved in analytical development and validation activities. In addition, this course may be of interest for RA personnel involved in filing analytical sections.

The aim of the course is to become familiar with the analytical lifecycle approach as presented in ICH Q14, learn the differences between ICH Q2(R1) and ICH Q2(R2) and how to apply these to design an analytical procedure lifecycle. 


This training is suitable for junior and experienced analytical, QC personnel. In addition, it is also valuable for personnel in related fields such as research and development and regulatory affairs. 


Sigrid Roosendaal 
Vicki Venizelos


English


•    Introduction to ICH guidelines
•    Overview of revision process for ICH Q2 and introduction of ICH Q14
•    Content of ICH Q2(R2) and ICH Q14
•    Differences between ICH Q2(R1) and ICH Q2(R2)
•    Discussion of examples for analytical techniques for analytical assays
•    Discussion of examples for analytical techniques for biological assays and quantitative PCR

 

4 hours


Analytical Development, Quality Control, Regulatory Affairs


€ 520 (excl. VAT). Lunch is included.


This course will be offered as a live training on 23 September 2022, in Leiden.
This course can also be given as an in-company training (send an email to info@qualityra.nl for a quotation).

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