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Category

Contamination Control Strategy in the Light of Annex 1 Implementation

Location

Online

Number of days

2

Provider / Trainers

Dr. Igor Gorsky

Certification

A Certificate of Attendance will be issued upon completion of the course.

Price:

 490

Select quantity:

Points of interest

PURPOSE

The Specialist Course in Contamination Control Strategy in the Light of Annex 1 Implementation aims to provide knowledge
and insight into the new version of Annex 1 “Manufacture of Sterile Medicinal Products” which came into force in August
2023. The new version of Annex 1 is significantly modified from the previous version, with a focus on critical analysis of
manufacturing processes, facilities and personnel training.
In addition, for the first time, there is a section dedicated to the use of “single-use” materials, which are revolutionizing
manufacturing processes, particularly for large molecule and advanced therapy products.

OBJECTIVES

The Specialist Course in Contamination Control Strategy in the Light of Annex 1 Implementation aims to provide new
elements to a professional capable of understanding the regulatory requirements aimed at designing the quality
and safety of sterile medicinal products with a risk assessment approach involving all aspects of production.