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In-house Training Programme

 
 

Hygiene Training Course

 
     
 
When What
Day 1  
09.00 - 10:00 BASIC MICROBIOLOGY
Occurrence and size of microorganisms
  • Effects caused by microorganisms
  • Properties of microorganisms
  • Diversity of microorganisms
  • Division and growth of microorganisms
  • Structures of microorganisms (cell walls, LPS, capsules, spores, flagellae)
  • Concepts of control of microorganisms
10:00 - 10:30 CLASSROOM EXERCISE
  • Participants work with the trainer on concepts for control of microorganisms.
10:30 - 11:00 BREAK
11:00 - 12:00 PERSONAL HYGIENE
  • Microflora of the human body
  • Personal cleanliness
  • Illness and health conditions
  • Entry into the facility
  • Visit of the toilet
  • Change and washing of garments
12:00 - 12:30 CLASSROOM EXERCISE
  • Participants work with the trainer on personal hygiene concepts.
12:30 - 13:30 BREAK
13:30 - 14:30 HYGIENE QUESTIONS OF NON-STERILE FACILITIES
  • Sources of microbiological contamination
  • Growth of microorganisms and hygiene problems
  • Entry and flow of personnel and material
  • Zoning and gowning in the facility
  • Behaviour of personnel
  • Contamination control in non-sterile environments
14:30 - 15:00 CLASSROOM EXERCISE
  • Work with the trainer on hygiene and contamination control concepts for non-sterile facilities
15:00 - 15:30 Break
15:30 - 16:30 CLEANING, DISINFECTION AND SANITISATION
  • Cleaning schedules and techniques
  • Classes of disinfectants and resistance of microorganisms
  • Evaluation of effectivity of disinfectants
  • Rotation and sterility of disinfectants
  • Methods of disinfection
  • Disinfection plans
16:30 - 17:00 CLASSROOM EXERCISE
  • Work on cleaning and disinfection questions with the trainer.
  • Develop cleaning and disinfection plans
Day 2  
9:00 - 10:00 BIOBURDEN OF MATERIALS AND INTERMEDIATES
  • Sources of contamination
  • Cleanliness of storage areas
  • Excipients, intermediates, packaging materials
  • International requirements
  • Methods of bioburden monitoring, pharmacopoeial methods
  • Bioburden sampling plans
10:00 - 10:30 CLASSROOM EXERCISE
  • Participants propose a list of actives, excipients and intermediates. Develop a sampling plan.
10:30 - 11:00 BREAK
11:00 - 12:00 WATER AND WATER SYSTEMS FOR PHARMACEUTICAL USE
  • International requirements
  • Water system microbiological considerations
  • Water system sanitization measures
  • Pharmacopoeial and alternative methods for monitoring of water and water systems
  • Auditing water - for - injection systems
12.00 - 12.30 CLASSROOM EXERCISE
  • Discuss the status of water systems based on fictive monitoring results as presented by the trainer (alternatively monitoring results presented by participants).

 

12:30 - 13:30 LUNCH
13:30 - 14:30 Requirements for Cleanrooms
  • Principles of segregation
  • Layout of cleanrooms
  • European vs. US requirements
  • Material and personnel flow
  • Cleanroom practices (access, gowning, comportment)
14:30 - 15:00 CLASSROOM EXERCISE
  • Develop approaches to the solution of cleanroom problems as presented by the trainer.
15:00 - 15:30 BREAK
15:30 - 16:30 ENVIRONMENTAL MONITORING OF FACILITIES FOR NON-STERILE AND STERILE PHARMACEUTICALS
  • International requirements
  • Methods of environmental monitoring
  • Sampling plans
  • Evaluation and interpretation of results
  • Identification of microorganisms
16:30 - 17:00 CLASSROOM EXERCISE
  • Develop reactions and investigation plans to fictive environmental monitoring results as presented by the trainer (alternatively monitoring results presented by participants).
 
 
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

 

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