President of VIALEK GROUP
International GMP/GDP expert, the Quality Auditor of the European Organization for Quality (EOQ)
2013
About the conference 2013
The fourth conference "Quality assurance of medicines 2013" will be held June 17-20, 2013. After an audit of the proposed site for the conference, the organizing committee chose the city of Sevastopol.
According to the organizers of the conference participants now need to prepare for nonstandard working day. Four days of the conference will be full of reports, held two round tables and three master classes. Quality of reporting will go up to the next level: the place of the theory replaces the practice, on each report will be two reviewers interested in the quality and utility presentation as a whole.
Public interviews will be held with directors of quality and production directors. Professional industry journalist will asked pointed questions.
The pharmaceutical needlework event will host, where everyone be able to improve the skills of their results of the professional activity. Prize will be awarded "Pharmaceutical Olympus" quality professionals in 7 categories.
Otherwise, everything will remain the same: "More interesting people with interesting ideas on the sea shore of the Black Sea!".
Section Speakers you can appreciate a list of all the speakers,and to find information on each speaker.
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Speakers 2013
Aleksandr Aleksandrov
Natela Karuhnishvili
Director of Quality, Qualified Person of the company "Aversi-Rational", Georgia
Stepan Artemchenko
Director of Research and Development, PJSC Pharmaceutical Factory "Viola", Ukraine
Sanja Peterlic
Mag. Med. Biochemistry - owner, CEO, senior consultant, trainer and auditor, SUPERA KVALITETA Ltd, Zagreb, Croatia
Michael Muzykin
Candidate of Pharmaceutical Sciences, Senior research scientist R&D laboratory, LLC "STPF "POLYSAN", Russia
Ismatdzhan Azizov
First Deputy Chief of the General Administration of Quality Control of Medicines and Medical Devices in the Republic of Uzbekistan
Conference Lectures 2013
as of 26/03/2013
Monday, June 17, 2013 , Day 1
|
Schedule |
Subjects |
|
10:00-10:30 |
Opening the conference, welcoming remarks from the organizers, partners |
|
10:30 – 11:15 |
Report № 1 – «The role of the Qualified Person in the changed European legislation» By Ella Joffe |
|
11:15 – 12:00 |
Report № 2 – «13 bad advice on implementation of GMP» |
|
12:00 – 12:30 |
Break |
|
12:30 – 13:15 |
Report № 3 – «The point of no return: How to avoid compromises with regard to quality issues» |
|
13:15-14:00 |
Report № 4 – «10 mandatory steps to successful FDA inspection» |
|
14:00-15:00 |
Lunch |
|
15:00-16:30 |
Master-class «Coercion to quality - Experience with Chinese suppliers of equipment» |
|
18:30 – 23:00 |
Awarding of "Pharmaceutical Olympus", evening banquet |
Tuesday, June 18, 2013 – Day 2
|
Schedule |
Subjects |
|
10:00-10:30 |
Public interview with the Director of Quality |
|
10:30 – 11:15 |
Report № 5 – «Formation of library defects for the organization of visual quality control» By Tatyana Drobylko |
|
11:15 – 12:00 |
Report № 6 - «The transition to GMP: raw material identification in the pharmaceutical industry with handheld Raman and NIR analyzers Thermo» |
|
12:00 – 12:30 |
Break |
|
12:30 – 13:15 |
Report № 7 – «The use of risk management tools for reviewing claims» By Andrzej Sharmansky |
|
13:15-14:00 |
Report № 8 – «Establishing control over the risks for quality starting from the development of design solutions» |
|
14:00-15:00 |
Lunch |
|
15:00-17:00 |
Business Game«Tools for quality assurance. Solution to the problem, the root cause determination» |
|
18:00 – 20:00 |
Evening of pharmaceutical needlework «Prepare creams, shampoos and masks their own hands» |
Wednesday, June 19, 2013 – Day 3
|
Schedule |
Subjects |
|
10:00-10:30 |
Public interview with the Development Director By Sergey Dontsov |
|
10:30 – 11:15 |
Report № 9 –«Practical issues of investigation results of quality control, beyond specification (OOS) » |
|
11:15 – 12:00 |
Report № 10 – «Quality as a result of engineering» |
|
12:00 – 12:30 |
Break |
|
12:30 – 13:15 |
Report № 11 - «Regulatory issues pharmaceutical business. Where can cause frequent changes?» |
|
13:15-14:00 |
Report № 12 –The topic is being clarified The speaker is being clarified |
|
14:00-15:00 |
Lunch |
|
15:00-16:30 |
Mini-Seminar «Rules of survival of the authorized person in the national legislation» |
|
17:00-19:00 |
Tour of Sevastopol |
Thursday, June 20, 2013 – Day 4
|
Schedule |
Subjects |
|
10:00-10:30 |
Public interview with the Director of Human Resources |
|
10:30 – 11:15 |
Report № 13 – «Secrets of using MS Excel to ensure the quality of medicines» |
|
11:15 – 12:00 |
Report № 14 - «Practical issues of validation of spreadsheets in Excel» |
|
12:00 – 12:30 |
Break |
|
12:30 – 13:15 |
Report № 15 – «The use of metal detectors in the pharmaceutical industry and flexible integration into production» A company representative LOCK Inspection
|
|
13:15-14:00 |
Report № 16 – «Risk management in a developing system of quality» |
|
14:00-15:00 |
Lunch |
|
15:00-16:30 |
Round table «GMP-inspection. Classification of the nonconformities and evaluation of the effectiveness of CAPA» - discussion of the results of the first round of proficiency testing QAD |
|
19:00 |
Visit to the theater |
Conference photo gallery 2013
Partners 2011
Partners 2012