Training

Closed trainings – organized by the PharmAK team

GMP – Good Manufacturing Practice

The Training programs are prepared individually for the Client’s needs. Sample scopes of issues below:

  1. Good Manufacturing Practice from the ground up
  2. GMP quality audits – workshops for internal GMP auditors
  3. Complaints, quality defects and product recalls
  4. Deviations in the manufacturing process, CAPA activities, OOX results – a practical approach
  5. Supervision of control and measurement equipment in a Pharmaceutical Plant
  6. Manufacture of investigational medicinal products on the basis of Annex 13
  7. Sampling – sampling of raw materials, packaging materials and final products
  8. Supervision of controlled substances in the manufacture, including processing of hemp and in distribution
  9. Technology Transfer of medicinal product
  10. Technology Transfer of active pharmaceutical substance (API)
  11. Certification by a Qualified Person and Batch Release under Annex 16 to GMP requirements
  12. Qualified Person participation in the quality management system
  13. Data analysis in quality processes. Deviations from trends
  14. Assessment of batch quality prior to certification and release for marketing
  15. Manufacturing of sterile medicinal products based on the new Annex 1
  16. Introduction to GMP for warehouse workers
  17. GMP in warehousing and distribution
  18. GMP for management and middle supervision
  19. Periodic GMPs for internal auditors and executives
  20. Ensuring the integrity of the active pharmaceutical substance (API) supply chain
  21. GMP and GDP compliant supply chain
  22. Quality Risk Management (QRM)
  23. Risk analysis in aseptic manufacturing
  24. Qualification of product and service suppliers
  25. Technical agreements – ensuring compliance of quality agreements
  26. Audit of manufacturers, distributors and importers of active pharmaceutical substances
  27. Preparation of manufacturing plants for GMP inspections
  28. Documentation of the Pharmaceutical Quality System
  29. 2-day Manufacturing of sterile medicinal products under the new Annex 1
  30. 2-day Training for GMP auditors – with workshops

GDP – Good Distribution Practice

The Training programs are prepared individually for the Client’s needs. Sample scopes of issues below:

  1. Basics of Good Distribution Practice
  2. Documentation of the Quality System in a pharmaceutical wholesaler in accordance with the GPD
  3. GPD for wholesale units
  4. Challenges and problems in the work of the Responsible Person
  5. Responsible Person in Pharmaceutical Wholesaler – responsibilities, authority and accountability
  6. Qualification of suppliers of products and services. Qualification of customers
  7. Risk management in wholesale and distribution
  8. Good Distribution Practice for auditors, including remote auditing
  9. Implementation of GDP in a pharmaceutical wholesaler
  10. Preparation of the wholesaler for inspection/audit
  11. Complaints, quality defects, recalls
  12. Validation of storage and transportation process
  13. Documentation in a Pharmaceutical Wholesaler in compliance with the GPD
  14. Most common errors during authority inspections (GIF) and how to fix them – CAPA actions plan
  15. Supervision of controlled substance in wholesale trade
  16. 2-day Good Distribution Practice for auditors – with workshop
  17. 2-day Risk Management in Wholesale and Distribution – with workshop

Trainings organized in cooperation with leading training companies

Trainings organized in cooperation with EduDirect