Seminar on 25-26 September 2017 «General requirements for qualification and validation»

FSI «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation conducts a training seminar

«General requirements for qualification and validation».

The seminar will highlight the following topics:

25 September, Day 1

1.     Basic principles and approaches to the implementation of qualification and validation activities to date (GMP EU, US FDA, ICH Q10);

2.     Legal documents on the regulation of procedures for validation and qualification. Appendix 15 «Qualification and validation (Order 916 of 14.06.2013). Trends in the development of approaches to validation and qualification. Some new trends reflected in the Annex 15 GMP EU;

3.     Planning and documentation of qualification and validation, the main validation plan (SMF);

4.     Basic approaches to the qualification of engineering systems and equipment (FAT, SAT, IQ, OQ, PQ) – sequence of actions, division of responsibility between departments.

26 September, Day 2

1.     General requirements for the qualification of clean rooms and areas;

2.     General requirements for the qualification of water treatment systems;

3.     General requirements for the qualification of equipment (case studies);

4.     General requirements for carrying out the thermal mapping of storage areas;

5.     General principles and approaches to process validation;

6.     Validation of cleaning processes. General requirements for the validation of equipment cleaning. Applicable criteria for purification validation.

18 academic hous in total.

The Seminar is conducted by:

Zhilin Aleksei Vladimirovich
Leading Specialist of Pharmaceutical Manufacturing Inspection Department of FSI «SID & GP»;

Smirnov Vladimir Alekseevich
Leading Specialist of Pharmaceutical Manufacturing Inspection Department of FSI «SID & GP»;

Arabadzhi Mikhail Aleksandrovich
Leading Specialist of Pharmaceutical Manufacturing Inspection Department of FSI «SID & GP».

Venue: to be confirmed

Contact person: Ekaterina Ryzhikova

E-mail: ekaterina.ryzhikova@sbmrussia.com

Phone: +7 (915) 455-65-78