Pharmaceutical engineering

16:45 — 18:30

Parallel Event

Pharmaceutical Engineering. The initial stages of acceptance and qualification as part of the validation lifecycle of systems and equipment. A look from the perspective of the requirements of GMP Appendix No. 15 and industry experience

Questions and topics for discussion:

  • Practical Application of the principles of the ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
  • The relation of the various stages of qualification in the V-shaped model of the «life cycle» of validation
  • URS as a «reference point» for validation activities
  • Importance of the DQ stage for new and reconstructed systems; application of risk analysis at the DQ stage taking into account the provisions of the updated version of the ICH guideline Q9 (R1)


Vladimir Orlov

Director of the Eurasian branch of ISPE — MAFI EAEU


Alexander Belinsky 

Technical Director, PQE CIS

Ivan Moiseev

Head of Validation Department, Geropharm LLC

Oleg Spitsky

Head of Quality System, Biofamrproekt LLC

Svetlana Skorik

Quality Director, Polysan LTD


Natalya Burlakina 

Deputy Head of the Expertise Department of the FSI «SID and NP» of the Ministry of Industry and Trade of the Russian Federation

Vladimir Smirnov

Deputy Head, Pharmaceutical Inspectorate Cooperation Division, FSI “SID & GP” of the Ministry of Industry and Trade of Russia