Quality Assurance Systems Based on ISO 9001 and GMP

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The agenda proposal aside 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.

Agenda Proposal

08.00 - 08.30 Welcome, Introduction, Presentation of the Speaker
08.30 - 09.30 Regulations and Requirements
  • Europe
  • FDA
  • Harmonised Requirements
09.30 - 10.30 Content of the ISO Norms
  • ISO 9001
  • ISO 13485
  • Applicable Norms
10.30 -10.45 Break
10.45 - 11.45 ISO versus GMP
  • Requirements of ISO
  • Requirements of GMP
  • Common and differences of ISO - GMP
  • Advantages of a combined system
11.45 - 12.45 Implementation and Maintenance of the Quality Assurance System
  • Quality Unit
  • Quality System
  • Definition of the requirements for the Quality Unit
  • Supervision of the system/requirements
12.45 - 13.45 Lunch
13.45 - 14.45 CFR 800 as a Practical Approach for Combination of GMP and ISO
  • Content of CFR 800
  • QSR
  • QSIT
  • Quality manual
14.45 - 15.00 Break
15.00 - 16.00 Documentation of the Quality System
  • SOPs
  • Quality policy
  • Quality manual
  • QA documents in general
16.00 - 17.00 Documentation and Archiving
  • Requirements for documentation and archiving
  • Time for archiving
17.00 - 17.30 Discussion

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