GMP Master Class

This course gives you a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements. This course is aimed to take you further in your understanding of GMP requirements and will assist you in your daily challenges either working in QA or with GMP related tasks in other parts of a pharmaceutical operation.

Course description

The course is split into a preparatory session* for you to do online at your own convenience followed by a 2-day intensive masterclass led by our highly experienced trainer. During these two days, you will get a full overview of requirements in both EU and US GMP as well as a number of practical class exercises. You will learn to understand, navigate, interpret and apply GMP in line with up-to date views on ICH guidelines on Pharmaceutical Quality System and Quality Risk Management.

*This session consists of an on-demand training session on the Premium part of our Compliance resource library Gate2Compliance plus a pre-read task. Upon registration, you will receive a link and information about your task, it must be completed before you arrive at the course. If you are already Premium member in Gate2Compliance,  the price for this course will be reduced with 295€.

Important GMP concepts such as Data Integrity, Validation, Change management and CAPA will be introduced

Course outline

• Preparatory session
  – How to read and interpret the GMP tests (on-line and on-demand)
• Day 1
  • Introduction
  • General requirements
  • Quality systems and Quality management
    • Risk management and Knowledge Management
  • Personnel
  • Buildings, facilities and equipment
  • Documentation
    • Data Integrity
• Day 2
  • Manufacturing
    • Validation
    • Change management
    • CAPA
  • Quality control and Laboratory GMPs
  • Outsourced activities
  • Complaints and recalls
  • Self-inspection
  • Specific guidelines
    • EU Annex 1-19
    • FDA CGMP Guidance for industry
    • PIC/S recommendations
  • Summary

Learning objectives

After this course, you will have a full overview of the contents of both EU and US GMP. You will also be able to distinguish between requirements, interpretations and industry practice. You will be equipped with tools and strategies to navigate the universe of GMP guidance documents and have enhanced your ability to apply current GMP requirements to potential challenges in the daily operations of a GMP environment.

Who should attend

The course is suitable for persons working with development, production, or QA who is involved in, or responsible for the operation or audit of pharmaceutical quality systems including GMP. Also those who need more knowledge about specific FDA requirements where these differ from EU GMPS will  benefit from this course.

Prerequisites

• You should have basic knowledge of GMPs, e.g. by participating in one of our basic courses or have equivalent knowledge.
• You should have at least 6-12 months experience of working in the regulated industry (Pharmaceutical manufacturing).

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