The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

ISPE EAEU Affiliate Opening Ceremony in the framework of Educational Conference: «Effective pharmaceutical production. Regulatory aspects, latest technologies»

16-17 October 2017 Educational Conference «Effective pharmaceutical production. Regulatory aspects, latest technologies» will take place in Moscow, in the framework of the Conference ISPE EAEU Affiliate Opening Ceremony presentation will be held.

In Conference programme:

1. Inspection of pharmaceutical production. Regulator’s view

  • Inspection organization, preparation and conduct
  • Responsibility of the manufacturer and the applicant
  • Analysis of the most frequent nonconformities identified during the inspection process.

2. Review of decisions and trends in the thermal validation market

  • Data loggers and thermopads
  • Validation of steam sterilizers
  • Overview of the latest technological solutions from the ELLAB A/S experience

3. The concept of continuous production by the example of an implemented project

  • Continuous granulation technology
  • Methods of continuous granulation applying
  • Implementation of the concept of continuous production by the example of Pfizer

4. Complex equipment of plants for the processing of blood plasma: production of various products from human blood plasma

  • Blood plasma – world technologies
  • The way from the donor center to factories by fractionation through biological and chemical analysis of the blood plasma
  • The most common methods of fractionation
  • The example of a realized project in accordance with GMP for the plant Kedrion

5. The newest technologies of pharmaceutical production. Investments and Results

  • Automation, modernization of production facilities, the latest world-class technologies
  • Evaluation of investment efficiency at the planning stage
  • Successful practices of the world’s leading manufacturers

6. The process of bio-decontamination with hydrogen peroxide vapor and the aseptic transfer of materials sensitive to high temperatures

  • Factors for choosing bio-decontamination of surfaces and available technologies
  • Quality by Design, risk assessment and mitigation actions to have a full control of the surface bio-decontamination process
  • Decontamination cycle and equipment features
  • Validation approach of bio-decontamination
  • Aseptic Processing Annex 1 Highly potent Biopharmaceuticals

7. Advantages of fully servo drive solutions and modular constructions for pharmaceutical equipment

  • Servo drive technologies and modular constructions
  • What is «modules» and what are the advantages of a modular construction
  • What is «servo drive technologies» and their application in modular constructions
  • Key advantages of servo drive technologies
  • Upgrade and modification

8. ISPE EAEU Affiliate Opening Ceremony in Russia

  • Cooperation agreements signing
  • Presentation of the global ISPE mission
  • The goals and objectives of the ISPE EAEU Affiliate

9. Effective management of pharmaceutical production. Strategic vision of Top Managers

  • Optimization of modern pharmaceutical production processes
  • Key performance indicators, labour productivity
  • Quality control management, automation of production, personnel qualification development

Venue: Moscow, ul. Tverskaya, 26/1, «Marriott Moscow Grand Hotel»

Contact person: Ekaterina Ryzhikova
E-mail: ekaterina.ryzhikova@sbmrussia.com
Phone: +7 (915) 455-65-78