Partners:

Cleaning validation services


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Denys Ostrovnoy

List of trainings

 

 

Date

Trainings

Duration

25.11.2011

Computerized systems validation

6

06.12.2011

Design, construction, commission, operation and qualification of Critical Utility systems:
 - 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 utility systems

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

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 maintenance and engineering department
 - 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

Theory and practice of GMP:
 -
personnel management system,
 - qualified person,
 - production complex:
   - process equipment,
   - cleanroom,
   - purified water,
   - water for injection,
 - production requirements,
 - documentation system.

10

10, 12
02.2014

Theory and practice of GMP:
 - 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 maintenance and engineering department

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

Theory and practice of GMP:
 - 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

Theory and practice of GMP

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

Theory and practice of GMP:
 - cleanroom
 - purified water,
 - water for injection,
 - sterile production.

8

26.06.2015

Sterile manufacturing in the pharmaceutical industry
 - GMP requirements,
 - decision tree for sterilization choices for aqueous products,
 - drug formulation,
 - Sterile filtration validation.

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

Production of Sterile Pharmaceuticals
 - GMP requirements,
 - decision tree for sterilization choices for aqueous products,
 - primary packaging washing and sterilization,
 - qualification of steam sterilizers, dry heat oven and tunnel,
 - sterilization processes validation,
 - drug formulation,
 - sterile filtration validation.

16

15 - 16
10.2015

Good Quality Control Laboratory Practice

4

29 - 30
10.2015
GMP for critical utilities

16

26 - 27
11.2015
Sterile manufacturing in the pharmaceutical industry
 - qualification of process equipment
 - process validation
 - sterile filtration validation
 - process simulation/media fill

16

13.05.2016 Sterile manufacturing in the pharmaceutical industry
 - sterile filtration validation
 - process simulation/media fill
8

20 - 21 .10.2016

Sterile manufacturing in the pharmaceutical industry
 - qualification of process equipment
 - process validation
 - sterile filtration validation
 - process simulation/media fill
16
3 - 4 .11.2016 GMP for maintenance and engineering department 16
13.05.2016 Manufacture of Sterile Medicinal Products 8

20 - 21 .10.2016

Sterile manufacturing in the pharmaceutical industry
 - qualification of process equipment
 - process validation
 - process simulation/media fill
16
3 - 4 11.2016 GMP for maintenance and engineering department 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 Sterile manufacturing in the pharmaceutical industry
 - qualification of process equipment
 - process validation
 - sterile filtration validation
 - process simulation/media fill
8
18 - 21
08.2017
Quality Risk Management 16
07.09.2017

Computerized systems validation

8
26 – 27 .10.2017

Sterile manufacturing in the pharmaceutical industry
 - qualification of process equipment
 - process validation
 - sterile filtration validation
 - process simulation/media fill

16
20.04.2018 Валидация стерилизующей фильтрации 1
21.05.2018

Computerized systems validation based on ISPE BASELINE ® - GAMP5 Guide

1
24-25 .05.2018 Manufacture of Sterile Medicinal Products
 - qualification of process equipment
 - process validation
 - sterile filtration validation
 - process simulation/media fill
16
05.06.2018 Data integrity 1
27.07.2018 Best practices for an effective cleaning validation program 7

 



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