Topic outline

• GMP Fasttrack
  

  GMP Fasttrack

  This is a fast-moving, intensive training course aimed at Managers, Supervisors and Technical Staff working in the pharmaceutical industry.

  As well as establishing the key requirements of GMP, the course focuses on the application of GMP in the working environment.
  

  
  

  	COM-060   UK  e-Learning  Role: Manager/Senior Manager, Supervisor, Technician  Compliance  Sector: Pharmaceuticals
  This Course is Aimed at
  Managers, Supervisors and Technical Staff working in the pharmaceutical industry.
  Overview
  With a strong regulatory focus on the use of a risk-based and information-driven approach to GMP compliance, delegates will be introduced to a number of science and risk -based management tools, techniques and methodologies. The course consists of a lively mix of presentations, group exercises and discussions. The exercises will be instructor-led, in breakout groups or by self-study. Presentation sessions will be limited to about one hour, with ample time between for delegates to work on the various exercises. The presenter will be available throughout. At the end of the course, there will be a short quiz to test understanding. Copies (pdf) of all presentation slides and handouts will be provided.  An information pack containing course details and preparatory exercises will be sent to each delegate prior to the start of the course.
  Programme Content and Key Areas
  Introduction to GMP Managing Quality Regulatory Approach to Risk Management – current and future trends Documentation and Records Contamination Control Manufacturing and Packaging GMPs PAT & Process Control Internal and External Audit Programmes Validation
  Learning Outcomes
  Provides a good grounding in the underlying principles, tools and methodologies of GMP. Shared experiences between delegates are used to illustrate the concepts. To book now contact us.
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