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 the  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