Training | On-Bir Institute

Training|
On-Bir Institute

Pharmaceutical training programmes by a scientist-led team with EU-GMP expertise.

01

Professional Training Open to the Pharmaceutical Industry

On-Bir Institute organizes open-enrollment training programs for pharmaceutical industry professionals, designed to address the evolving needs of the industry and the latest regulatory requirements. Our training programs cover GMP, Quality Assurance (QA), Quality Control (QC), Validation, Qualification, Regulatory Affairs, R&D and other technical areas, and are delivered by experienced industry experts. By combining theoretical knowledge with real-world industry practices, we foster knowledge sharing within the pharmaceutical sector and contribute to the continuous professional development of industry professionals.

02

Customized Trainings

On-Bir Institute offers customized training programs delivered directly at companies' own facilities, tailored to their specific needs and requirements. Training programs included in our catalog can be adapted to meet each company's specific needs. Additionally, entirely new training content can be developed based on an organization's unique requirements and professional development objectives. Delivered by experienced industry experts, our training programs incorporate current national and international regulations, industry-specific requirements, and practical, real-world examples. At On-Bir Institute, we bring training directly to your workplace, providing tailored learning solutions that enhance your employees' professional competencies and contribute to the continuous improvement of your operational processes.

03

Corporate Training Packages

On-Bir Institute offers corporate training packages with competitive pricing and flexible payment options, making professional training more accessible and sustainable for companies seeking cost-effective and flexible solutions to their training needs. By combining various training programs, we develop comprehensive training packages tailored to each organization's objectives, specific needs, and budget. Our training programs are scheduled according to each company's operational requirements and availability, ensuring that employees' professional development is supported while maintaining business continuity.

Training Catalogue Content

The training programs included in the On-Bir Institute Training Catalogue are listed below.

  1. 1Basic GMP and Hygiene
  2. 2EU GMP Annex 1: Manufacture of Sterile Medicinal Products
  3. 3Advanced GMP
  4. 4Quality Metrics, Key Performance Indicators (KPIs), and Key Behavior Indicators (KBIs)
  5. 5Quality Culture and Quality Management Maturity (QMM)
  6. 6Deviation and Corrective and Preventive Action (CAPA) Management, Root Cause Analysis Techniques
  7. 7Management of Out-of-Specification (OOS), Out-of-Trend (OOT), and Out-of-Expectation (OOE) Results in Compliance with FDA Guidance
  8. 8Effective Change Control Management
  9. 9Qualification and Validation
  10. 10Cleaning Validation Based on Health-Based Exposure Limits (HBELs)
  11. 11HVAC System Qualification
  12. 12Pharmaceutical Water System Validation
  13. 13Real-Time Release Testing (RTRT) and Parametric Release
  14. 14ICH Q9 Quality Risk Management (QRM) and Practical Risk Assessment Methodologies
  15. 15Process Validation and Its Stages: A Lifecycle Approach
  16. 16Continued Process Verification (CPV) Throughout the Product Lifecycle
  17. 17Aseptic Process Simulation (APS) in Compliance with EU GMP Annex 1
  18. 18Risk-Based Prevention of Cross-Contamination and Development of Containment Strategies
  19. 19Development of a Contamination Control Strategy (CCS)
  20. 20Establishment of an Aseptic Observation Program and Performance Evaluation of the Contamination Control Strategy (CCS)
  21. 21Supplier Auditing and Supplier Qualification
  22. 22Product Quality Review (PQR) / Annual Product Review (APR)
  23. 23Statistical Applications in the Pharmaceutical Industry
  24. 24HACCP Applications in the Pharmaceutical Industry
  25. 25Pharmaceutical Technology Transfer
  26. 26Guideline-Compliant Risk Assessment of Pharmaceutical Excipients
  27. 27Assessment of Elemental Impurities in Compliance with ICH Q3D
  28. 28Nitrosamine Risk Assessment
  29. 29Trainer Program for GMP Trainers
  30. 30Design and Management of Stability Studies in Compliance with ICH Q1, Including Statistical Evaluation of Stability Data
  31. 31Analytical Method Development Using Quality by Design (AQbD) Principles (ICH Q14) and Analytical Method Validation (ICH Q2)
  32. 32Effective Analytical Method Transfer
  33. 33Quality by Design (QbD) in Compliance with ICH Q8 and Practical Design of Experiments (DoE)
  34. 34Lean Laboratory Management
  35. 35Good Laboratory Practice (GLP)
  36. 36GMP Internal Auditing
  37. 37Good Distribution Practice (GDP)
  38. 38Filter Validation
  39. 39Compressed Air System Qualification
  40. 40Turkish Market-Drug Regulatory Affairs Training
  41. 41EU-Drug Regulatory Affairs Training

Interested in Our Training Programmes?

Contact us to discuss yearly planned trainings, customised workshops, or to request the training catalogue.

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