25. Hygiene Rules (pharmaceutical sector, farm produce industry/ agribusiness, medical device)

• Trends in hygiene requirements
• Staff motivation
• Staff training
• Obvious aims of compliance with the rules
• Decontamination rules (preventive and corrective action)
• Levels of hygiene depending on the various categories of premises

26. Principles of organisation in a hospital environment


27. Presentation of the GMP FDA for medical devices

• Comparison between GMP FDA and European B.P.F.
• Particular requirements for the management system
• Comparison between European B.P.F. and ISO 9001
• Particular requirements for the pharmaceutical circle (processes approach and mastership of processes risks)

28. Presentation of good pharmaceutical manufacturing practices

29. Good cosmetic manufacturing practices

30. Good Distribution Practices

• Presentation of US requirements
  
• Presentation of European Guidelines (94/c63/03)
• GDP as part of an ISO 9000 quality system
  
• Levels of tracebility in relation to the category of medical device

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