GMP

Good Manufacturing Practice Training

This course is prepared for companies and individuals that need to get familiar with the fundamentals of Good Manufacturing Practice. It covers the latest GMP guidelines, principles and requirements.

€59 Enroll

Why enroll in this course?

Course Syllabus

  • What is GMP
  • Why is GMP Important?
  • The Main Risks
  • Good Manufacturing Practice - Directives
  • Recent GMP Updates
  • Basic GMP Requirements
  • Principle
  • Overview
  • Updates
  • Implementation
  • Objectives
  • KNOWLEDGE CHECKPOINT
  • Management Review
  • Product Quality Review
  • Product Quality Review Scheduling
  • Conducting and Documenting a PQR
  • Principle
  • Key Personnel
  • Qualified Person
  • Head of Production Department
  • Head of Quality Control
  • Person Releasing the Batch
  • Consultants
  • Personnel Training
  • Personnel Hygiene
  • Principle
  • Premises
  • Production Area
  • Storage Area
  • Weighing areas
  • Quality Control Areas
  • Ancillary Areas
  • Equipment
  • Principle
  • Generation and Control of Documentation
  • How to make a correction
  • KNOWLEDGE CHECKPOINT
  • Good Documentation Practices
  • Required GMP documentation
  • Retention of Documents
  • Principle
  • General
  • Prevention of cross-contamination in production
  • Technical Measures
  • Organizational Measures
  • Product risk assessment and demonstration of suitability
  • Principle
  • Good Quality Control Laboratory Practice
  • Documentation
  • Sampling
  • Testing
  • Ongoing Stability
  • Technical transfer of testing methods
  • Principle
  • Complaints and Quality Defects
  • Quality Defect Investigation
  • Product Recalls
  • KNOWLEDGE CHECKPOINT
  • Classification of Defects
    • Class I Defects
    • Class II Defects
    • Class III defects
  • Rapid Alert Notification of a Quality Defect
  • Rapid Alert Notification Form

Ready to get started?

€59 Enroll