[Monday, June 18, 2012] – Day 1 |
| 10:00 – 17:00 |
Registration for the conference |
| 10:30 – 11:15 |
Opening of the conference – Opening speech of the organizers,
representatives of regulatorybodies and public organizations |
| 11:15 – 12:00 |
Report 1 Modern System of Quality Control of Medicines
Natalya D. Bunyatyan |
| 12:00 – 12:30 |
Coffee break |
| 12:30 – 13:15 |
Report 2 The Experienceof the Republic of
Kazakhstan in the Registration of the Medicines and the Establishment of National
Pharmacopoeial Standards
By Ardak U.Tulegenova
|
| 13:15 – 14:00 |
Report 3 Practice of Incorporating the ICHQ 10 Principles in the Quality System of Modern Pharmaceutical Company
By
Svetlana I.Skorik
|
| 14:00 – 15:00 |
Lunch break |
| 15:00 – 15:45 |
Report 4 Managing Corrective and Preventive Actions (CAPA)
By Alla A. Teterina |
| 15:45 – 16:30 |
Roundtable discussion |
| 19:00 – 23:00 |
Banquet |
[Tuesday, June 19, 2012] – Day 2 |
| 10:30 – 11:15 |
Report 5 Documentation of Change Control
By Natalia I. Gudushauri |
| 11:15 – 12:00 |
Report 6 Risks at Drug Development
By Veniamin A. Khazanov
|
| 12:00 – 12:30 |
Coffee break |
| 12:30 – 13:15 |
Report 7 New FDA Approaches to the Process Validation
By
Roman V. Loretts |
| 13:15 – 14:00 |
Report 8 Self-Inspection under GMP: the Experience of Foreign
Companies
By Andrew P. Meshkovskii |
| 14:00 – 15:00 |
Lunch break |
| 15:00 – 15:45 |
Report 9 Self-Inspection of Process Validation
By
Igor V. Topnikov |
| 15:45 – 16:30 |
Roundtable discussion |
| 21:00 – 24:00 |
Football club |
[Wednesday, June 20, 2012] – Day 3 |
| 10:30 – 11:15 |
Report 10 Suppliers’ Audit
By
Valentina K. Vigran
|
| 11:15 – 12:00 |
Report 11 Review of Regulationson the Results of the FDA
Inspections for 2010-2011
The speaker is being clarified |
| 12:00 – 12:30 |
Coffee break |
| 12:30 – 13:15 |
Report 12 Removal of the Notorious "Human Factor"
The speaker is
being clarified |
| 13:15 – 14:00 |
Report 13 Leadership -What OOO (KLO) Can Learn from the Climbers and
Tourists
By
Taras P. Kalita |
| 14:00 – 15:00 |
Lunch break |
| 15:00 – 15:45 |
Report 14 Risk Assessment at Creating the Incentives System for the
Quality Director
By Elena V. Lifanova |
15:45 – 16:15 |
Official closing of the conference |
| 17:00 – 19:00 |
Audit of the production sites |
[Thursday, June 21, 2012] – Day 4 |
| 10:30 – 12:00 |
Master-class European Certification Experience of Authorized Persons
The speaker is being clarified |
| 12:00 – 12:30 |
Break |
12:30 – 14:00 |
Master-class Risk Assessment at Selecting Project Decisions/Solutions
on the Personnel Separation and Material Flows
By a FAVEA
representative |
14:00 – 15:00 |
Lunch break |
15:00 – 16:30 |
Master-class Remain a Firefighter or Become a Therapist? Professional
Selection of Quality Manager(Overcoming the Personnel Resistance)
By Aleksandr V. Aleksandrov |
