Pharmaceutical engineering
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)
MODERATORS
Vladimir Orlov
Director of the Eurasian branch of ISPE — MAFI EAEU
SPEAKERS
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
FRONT-ROW EXPERTS
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