Dear colleagues!

I am happy to welcome you at the website of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) annual Seminar for GMP inspectors.

This year’s Seminar with the topic "Qualification and Validation: Today and Tomorrow" will be held in Kyiv, the capital of Ukraine from 3 to 5 October 2012.

The fact that PIC/S entrusted State Administration of Ukraine on Medicinal Products (SAUMP) with such great responsibility is a sign of high confidence in us. We are conscious of a great responsibility and are proud of this choice.

The main goal of this year`s Seminar is to give to GMP inspectors  theoretical and practical knowledge of new approaches to qualification and validation (Q&V), the theory and practice of Process Analytical Technology (PAT), control strategy of Real Time Release Testing (RTRT) and other important issues.

 

Practical aspects will cover the following topics:

  - Quality Risk Management (QRM) application for classification of deficiencies in production equipment qualification;

  - Risk Based Aseptic Processes Validation - view of inspector;

  - Main points for inspecting PAT and RTRT;

  - Implementing New Validation Approaches.


I am confident that this Seminar will be useful in providing GMP inspectors with important information.

We cordially invite you to actively participate in this Seminar and wish all participants much inspiration and success in cooperation and constructive exchange of knowledge.


Best regards

Head of State Administration of Ukraine on Medicinal Products

Oleksiy Solovyov