PROGRAM

of XVIth ASENMCO Conference

“GMP rules: Goals and experience. Cleanroom Technology”

31 May – 1 June 2005

Conference hall

of Federal Agency for Technical Regulation and Metrology

31 May, Tuesday

09.00 – 10.00 / Registration of participants
10.00 – 10.05 / Opening of the Conference
Chairman Dr. A. Fedotov, President ASENMCO
10.05 – 10.30 / Development of pharmaceutical industry and quality control systems for medicinal products
Dr. M. Getman, Federal Service for healthcare and social defense
10.30 – 10.50 / Technical regulation in modern world
V. Zimnik, Head of Department of Federal Agency for Technical Regulation and Metrology
10.50 – 11.30 / GMP Rules and Cleanroom Technolgy. Quality management systems: Myths and Reality. Qualified persons
Dr. A. Fedotov, President ASENMCO, Chairman of Technical committee for Standardization TC 458 “Manufacturing and quality control of medicinal products” and TC 184 “Industrial cleanliness”
11.30 – 12.00 / Inspections of pharmaceutical plants. Problems and difficulties of implementation of GMP Rules
Dr. A. Trapkova, Deputy Head of Department for State control of medicinal products of Federal Service for healthcare and social defense
12.00 – 13.00 / Prefilled syringes, Overview about syringe types and the
requirements on the production of sterile syringes
Dr. T. Schönknecht, Bünder Glas GmbH, Germany
13.00 – 14.00 / Lunch

Chairman Dr. V. Mikhailenko, ASENMCO Board Member

14.00 – 14.45 / Development of medicinal products and GMP Rules
Dr., Prof. N. Lyapunov, Head researcher of State Center for Drug control, Kharkov, Ukraine
14.45 – 15.30 / Design Qualification of Cleanrooms
Dr. H. Schicht, “Dr. Hans Schicht AG”, Switzerland
15.30 – 15.40 / Break
15.40 – 16.30 / Qualification out of the view of an installation company
M. Wiedmann, Hecht International GmbH + Co. KG, Germany
16.30 – 17.15 / Risk analysis during design, construction and operation of pharmaceutical plants
Dr. V. Mikhailenko, Company Pharmengineer, Kiev, Ukraine
17.15 – 18.00 / ASENMCO Meeting

1 June, Wednesday

Chairman N. Okunsky, Vice President of ASENMCO

09.30 – 10.10 / Technological part as a basis for design of manufacturing sites with cleanrooms
V. Yakukhina, Company Invar
10.10 – 11.00 / Design of pharmaceiutical plants according to GMP rules
V. Bylenky, company Uhde, Germany
11.00 – 11.15 / Break
11.15 – 11.40 / Quality assurance in manufacturing of medicinal products
Dr. V. Gandel, Head specialist of Company “Pharmstroy Group – Center of professional training”
11.40 – 12.00 / Experience of manufacturing and construction of cleanroooms
V. Suprun, General director of company “Miass plant of medical equipment”
12.00 – 12.20 / Manufacturing of cleanroom constructions according to GMP Rules and ISO standards
I. Garasim, General Director of Company “Polykor”, Lvov, Ukraine
12.20 – 12.40 / Qualification of water treatment sytems
A. Prihodko, Company “Mediana-Filter”
12.40 – 13.00 / Discussion
13.00 – 14.00 / Lunch

Chairman V. Fedorovich, ASENMCO Board Member

14.00 – 14.45 / Cleanrooms operation. GOST R ISO 14644-5
T. Bobrova, Executive Director of ASENMCO,
Secretary of TC 184 “Industrial cleanliness”
14.45– 15.15 / Risk analysis of obtaining false results during microbiological quality control of medicinal products
Dr. O. Gunar, Head of microbiological laboratory of State Institute Drug Control
15.15 – 15.45 / Qualification, testing and monitoring of cleanrooms according to GMP and ISO requirements
Dr. A. Fedotov
15.45 – 16.15 / Qualification of sterilization processes and analytical methods
V. Fedorovich, Director of Company “Ecotest”
16.15 – 16.45 / Discussion