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 |