Denys Ostrovnoy
Trainings Archive
Date | Trainings | Duration |
25.11.2011 | Computerized systems validation | 6 |
06.12.2011 | Design, construction, commission, operation and qualification of critical utilities: - purified water, - water for injection, - pure steam, - compressed air |
6 |
07.02.2012 | Quality risk management | 7 |
03.2012 | Computerized systems validation | 7 |
12-13 03.2012 |
Design, construction, commission, operation and qualification of critical utilities | 7 |
08.2012 | Critical utilities in the pharmaceutical industry | 7 |
12.09.2012 | Design, construction, commission, operation and qualification - process equipment, - cleanroom, - purified water, - water for injection |
4 |
28.11.2012 | Process validation (WHO) | 3 |
05.12.2012 | Process validation: - regulatory requirements, - terminology, - interconnection between quality assurance and validation, - validation documentation, - sampling plan |
7 |
10.12.2012 | Design, construction, commission, operation and qualification: - process equipment, - cleanroom, - purified water, - water for injection |
4 |
15.05.2013 | Production of sterile pharmaceuticals: - cleanroom, - RABS & isolator, - BFS, - personnel, - MFT |
7 |
13-14 06.2013 |
Training for GMP inspectors, Turkmenistan |
16 |
09.09.2013 | Design, construction, commission, operation and qualification: - process equipment, - cleanroom, - purified water, - water for injection |
4 |
05-06 11.2013 |
GMP for engineering and servise departments: - quality risk management in pharmaceutical design, - cleanroom and HVAC, - general requirements for process equipment, - clean-in-place (CIP) and steam-in-place (SIP). |
16 |
28.11.2013 | Process validation: - regulatory requirements, - terminology, - interconnection between quality assurance and validation, - sampling plan, - validation documentation, - examples. |
7 |
09, 11 12.2013 |
Basic Training on Good Manufacturing Practices: - personnel management system, - qualified person, - production complex: - process equipment, - cleanroom, - purified water, - water for injection, - production requirements, - documentation system. |
10 |
10, 12 02.2014 |
Basic Training on Good Manufacturing Practices: - personnel management system in accordance with GMP requirements, - qualified person, - documentation system, - general requirements for process equipment, - production requirements, - cleanroom, - purified water, - water for injection. |
10 |
13 - 16 05.2014 |
Training for GMP inspectors - personnel management system in accordance with GMP requirements, - documentation system, - general requirements for process equipment, - purified water and water for injection systems, - pure steam and compressed air systems, - cleanroom: - requirements, - AHU, - air purification, - design, - optimum air pressure differences between premises, - qualification and requalification, - system monitoring, - inspection practices. |
28 |
30.05.2014 | Cleanroom: - requirements, - AHU, - air purification, - design, - optimum air pressure differences between premises, - qualification and requalification, - system monitoring, - inspection practices. |
7 |
30-31 11.2014 |
GMP for engineering and servise departments | 14 |
27.11.2014 | Process validation: - regulatory requirements, - terminology, - interconnection between quality assurance and validation, - sampling plan, - validation documentation, - examples. |
7 |
08 - 10 12.2014 |
Basic Training on Good Manufacturing Practices: - personnel management system, - documentation system, - general requirements for process equipment, - production requirements, - purified water and water for injection systems, - cleanroom. |
10 |
16 - 18 12.2014 |
Basic Training on Good Manufacturing Practices | 14 |
16 – 17 04.2015 |
Critical utilities: - Quality Risk Management in pharmaceutical design, - purified water, - water for injection, - pure steam, - compressed air - restricted access barrier systems (RABS) & isolator - cleanroom: - requirements, - AHU, - air purification, - design, - optimum air pressure differences between premises, - qualification and requalification, - system monitoring, - inspection practices. |
14 |
18 - 19 05.2015 |
Basic Training on Good Manufacturing Practices: - cleanroom - purified water, - water for injection, - sterile production. |
8 |
26.06.2015 | Manufacture of sterile pharmaceutical products training course | 7 |
02.07.2015 | Cleanroom, RABS and isolator - cleanroom: - requirements, - AHU, - air purification, - design, - optimum air pressure differences between premises, - qualification and requalification, - system monitoring, - inspection practices, - restricted access barrier systems (RABS), - isolator. |
6 |
24.07.2015 | Process equipment for production of sterile pharmaceuticals | 6 |
10.08.2015 | Computerized systems validation | 7 |
17 - 18 08.2015 |
Manufacture of sterile pharmaceutical products training course | 16 |
15 - 16 10.2015 |
Good quality control laboratory practice | 4 |
29 - 30 10.2015 |
GMP for critical utilities | 16 |
26 - 27 11.2015 |
Qualification and validation in manufacturing of sterile products | 16 |
13.05.2016 | Manufacturing sterile products, validation of sterile filtration | 8 |
20 - 21 10.2016 |
Qualification and validation in manufacturing sterile products | 16 |
3 - 4 .11.2016 | GMP for engineering departments | 16 |
13.05.2016 | Manufacture of Sterile Medicinal Products | 8 |
20 - 21 10.2016 |
Manufacture of sterile pharmaceutical products training course | 16 |
3 - 4 11.2016 |
GMP for engineering and servise departments | 16 |
22.11.2016 | Validation of computerized systems | 8 |
15 - 16 12.2016 |
Good Quality Control Laboratory Practice | 4 |
14 - 16 02.2017 |
- Application of Quality Risk Management to Pharmaceutical Operations - Pharmaceutical Water Systems - Cleanrooms in Pharmaceutical Production - Validation of Computerized Systems |
20 |
18.05.2017 | Manufacture of sterile pharmaceutical products training course | 8 |
18 - 21 08.2017 |
Quality risk management | 16 |
07.09.2017 | Computerized systems validation |
8 |
26 – 27 10.2017 |
Manufacture of sterile pharmaceutical products training course | 16 |
20.04.2018 | Sterile Filtration Validation Best Practices | 1 |
21.05.2018 | Computerized systems validation based on ISPE BASELINE ® - GAMP5 Guide | 1 |
24 - 25 05.2018 |
Sterile Pharmaceutical Manufacturing Facility Training Course | 16 |
05.06.2018 | Data integrity assurance | 1 |
27.07.2018 | Cleaning Validation Principles Training Course | 7 |
27-28 .09.2018 | GMPs for engineering and design departments | 14 |
17.04.2019 | Recent changes in GMP guidelines | 1 |
13.06.2019 | Trend analysis and ongoing process verification during lifecycle | 6 |
21.06.2019 | Data integrity and computerized systems validation | 6 |
16.07.2019 | Sterile manufacturing and sterile filtration validation. Lviv city. | 7 |
18 - 19 .07.2019 |
Basic Training on Good Manufacturing Practices. Lviv city. | 7 |
23 - 24 07.2019 |
GMP for engineering department. Lviv city. | 14 |
09.08.2019 | GMP requirements for contractors. Bila Tserkva city. | 4 |
17.09.2019 | Classification of GMP deficiencies in accordance with PIC/S guidance PIC/S PI 040-1 Model for risk-based inspection planning in theĀ GMP environment PIC/S PI 037-1 |
2 |
04.10.2019 | Ongoing Process Verification during Lifecycle | 7 |
14 - 15 11.2019 |
Manufacture of sterile pharmaceutical products by aseptic processing and terminal sterilization | 14 |