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Content

GMP Operations


GMP Operations



WORKING IN CLEAN AIR

This program details the principles of working in 'clean air'. Content includes: Who needs clean air ?; What is clean air ?; Clean air standards; Clean air workstations; The nature of contamination; People - hygiene & apparel; Working in unidirectional airflow; Monitoring & maintenance; Review.

DVD-ROM / 2010 / () / 35 minutes

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WORKING UNDER GMP CONTROLLED CONDITIONS

This program was produced at customer request to address the training requirements of staff in mainstream human and animal GMP production, including medical devices, tablets, contact lenses, cosmetics and etc. Subjects include: Health and healthcare; 'GMP'; Premises and the environment; Ingredients and contaminants; The process; People; Summary.

DVD-ROM / 2009 / () / 25 minutes

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INTRODUCTION TO MICROBIOLOGY & GMP

This new release is the latest of the new generation multi-media training products from MVI Training Presented in 7 parts plus part-by-part Review section. This complete course is a primer designed both for training new personnel and re-training all existing personnel who are subject to cGMP regulatory compliance and need to understand the implications of microbiology and its control.

DVD-ROM / 2004 / () / 32 minutes

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CONTAMINANTS & THEIR SOLUTIONS

A fundamental program for all who must control contamination. Contaminants are examined in detail, together with the solutions for their control. Contains instruction on: preventing contamination; non-viable contamination; particle adhesion; chemicals; removing particles; static electricity; viable contamination; controlling microorganisms; disinfectants.

DVD-ROM / / () / 35 minutes

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CORRECT BEHAVIOUR IN THE CLEANROOM

This program demonstrates how behavior influences the performance of a cleanroom. Content includes: So you're going to work in a cleanroom? Cleanrooms explained; Contaminants and the contaminators; How to behave; Summary.

DVD-ROM / / () / 18 minutes

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EQUIPMENT & MATERIAL SELECTION

Precision cleaning requires that materials and equipment are totally compatible to the task. This module provides the necessary information from which to make such selections. Contains instruction on: how to understand the needs; the criteria of selection; types of vacuum; wipers and their uses; the chemistry of cleaning; selecting cleaning agents and choosing disinfectants.

DVD-ROM / / () / 34 minutes

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EU GMP: AN INTRODUCTION TO THE EUROPEAN UNION AND ITS CONTROL OF MEDICINAL PRODUCTS

The first program in a series designed to explain the European 'Guide to Good Manufacturing Practice'.

The program includes:
Part 1: Introduction
Part 2: The European Union
Part 3: Legislation
Part 4: EU legislation affecting pharmaceuticals
Part 5: EU legislation affecting GMP
Part 6: Summary


DVD-ROM / / () / 12 minutes

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EUROPEAN GMP: THE QUALIFIED PERSON

Another program in a series designed to explain EU GMP. This module explains what is meant by 'Certification before Release' and by the term 'Qualified Person'.

The program includes:
Part 1: 'Certification' and 'Release' of batches
Part 2: The Requirements for 'Certification'
Part 3: The Qualified Person
Part 4: Who is eligible to be named as a Qualified Person?
Part 5: How does the Qualified Person fulfil his or her responsibilities?
Part 6: Summary


DVD-ROM / / () / 20 minutes

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FOCUS ON GXPS

Everyone needs to be reminded to keep their focus on their job¡Xand FOCUS on GXPs is the perfect way to make sure that happens. These six real-world DVD programs are based on actual incidents and shot in a pharmaceutical manufacturing facility. They show what can happen when employees lose their focus on the job.

What's FOCUS? It's used as an acronym that encourages people to:

F - Focus on their job
Focus on the job at hand. Give it all your attention. Don't let yourself be distracted or preoccupied with something else. Talk to everyone involved with the job so all of you clearly understand what's to be done.

O - Organize their work
Organize your work so well that you won't have a chance to make mistakes. A well-organized workplace helps you stay error free.

C - Check their procedures
Check the SOPs for the job. Don't do the job until you've checked those all-important operating procedures. They're your guide for consistent work.

U - Use the right tools and equipment; wear the appropriate clothing
Use the right tools and equipment for the job. Make sure that they're in good condition. And wear the proper clothing required for the job.

S - Sum up the job when it's complete
Did you do the job as intended? Did you document the work properly? It's a chance to ensure you followed all the FOCUS steps before you leave any job.


6 DVD-ROMs / / () / Approx. 48 minutes

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INTRODUCTION TO STERILE & ASEPTIC PRODUCTION

A completely new visualization of core sterile learning module with intelligent assessment to promote the performance and quality required in sterile and aseptic environments.

This program is an introduction to the subject illustrating the reasons for, and the controls related to, sterile and aseptic production. The subject chapter headings are:

  • Introduction
  • The Contaminants
  • Sterile Production
  • Clean Environments
  • Personnel & Sterility
  • Cleaning & Disinfection
  • Preparation & Processing
  • Methods of Sterilization


  • DVD-ROM / / () /

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