Cleaning validation

Denys Ostrovnoy

Independent Pharmaceutical GMP Consultant

- 2004 Kyiv National Technical University Master of Science in Industrial Biotechnology
- 2007 Kyiv National Economic University Master of Science in Economics of enterprise

From 2004 till 2015 attended more than 20 trainings on: control and quality assurance, inspection, management and project management.
Participated in annual PIC/S seminars.

Denys Ostrovnoy

Jan 2015 – till present
Consultant GMP
at United States Pharmacopeial Convention
- Carrying out GMP audits,
- Performing CAPA analysis,
- Conducting trainings on GMP requirements,
- Consultation on quality assurance,
- Assistance in documentation development.

2012 – 2015
Expert at State Training Centre of Good Manufacturing / Distribution Practice.
Conducted more than sixty inspections of pharmaceutical manufacturing sites to assess compliance with GMP Guidelines.
Conducting lectures on GMP issues for:
- pharmaceutical manufactures in Ukraine and abroad,
- state authorities (Russian Federation, Turkmenistan),
- trainings on GMP Guidelines were highly evaluated by World Health Organization.

From 2010 to 2011 worked for CJSC "Indar" on position of a head of quality assurance department.

From 2004 to 2010 worked for JSC "Kyivmedpreparat" and Corporation "ARTERIUM" at first, as a validation engineer, later as a quality manager and project manager.





Process approach implementation training:
 - description of business processes,
 - business process reengineering,

Pharmaceutical Quality System

Change management system
Deviation management system

Product quality review

Quality Risk Management based on ICH Q9:
 - risk identification methods,
 - risk analysis by Ishikawa diagram,
 - risk evaluation by Failure Mode Effects Analysis (FMEA)
 - risk Reduction methods,
 - risk Acceptance.

GMP requirements for personnel

Documentation management system

GMP requirements for logistics:
 - Good Transportation Practices
 - Good Purchasing Practices
 - Good Storage Practices

Validation master plan and qualification protocol development

Cleanroom management in pharmaceuticals:
 - requirements,
 - AHU,
 - air purification,
 - design,
 - optimum air pressure differences between premises,
 - qualification & requalification,
 - system monitoring,
 - inspection practices,
 - deviation management.

Restricted Access Barrier Systems (RABS) & Isolator

Purified water and water for injection systems
 - requirements,
 - production,
 - storage and distribution,

 - qualification,
 - monitoring,
 - inspection.

Pure steam and compressed air systems

General requirements for equipment

Sterile manufacturing equipment. Equipment qualification

Clean-in-Place (CIP) and Steam-In-Place (SIP)

  General requirements for technological process
Sterile production

Process validation

Sterilizing filtration validation

Cleaning validation

Media fill test

Computerized systems validation

Process Analytical Technology
Good Quality Control Laboratory Practice
 - Update to EU GMP Quality Control requirements,
 - Out Of Trend (OOT),
 - Test methods transfer
Preparing for a GMP Inspection

Inspection technique

History of trainings Архив Архів

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