Pharmaceutical Quality Systems

This is how your training course could look like:

Do you need an individual offer for your company?

Send us an e-mail indicating your topic(s) of interest.

Please note that we need about 3 months preparation for the organisation of your in-house training course.

08.00 - 08.30 Welcome, Introduction, Presentation of the Speaker
08.30 - 09.30 GMP-Regulations and GMP-Requirements for a Quality System
  • European GMP Guideline
  • ICH Q10
  • Quality System
09.30 - 10.30 ISO versus GMP
  • Requirements of ISO
  • Requirements of GMP
  • Common and differences of ISO - GMP
  • Advantages of a combined system
10.30 -10.45 Break
10.45 - 12.15 Implementation and Maintenance of the Quality Assurance System
  • Requirements of the FDA
  • Quality Unit
  • Definition of the requirements for the Quality Unit
  • Supervision of the system/requirements
  • Quality Oversite
12.15 - 13.15 Documentation of the Quality System
  • SOPs
  • Quality policy
  • Quality manual
  • QA documents in general
  • Archiving
13.15 - 14.15 Lunch

 

14.15 - 15.30 Elements of and Responsibility for a Quality Assurance System
  • Qualification / validation
  • OOS
  • Deviation / Change control
  • Auditing
  • Training
  • etc.
15.30 - 15.45 Break
15.45 - 16.30 QA-System in Research and Development
  • QA system in research
  • QA system in development
  • Project management
  • Connection of R. A. D. to production
16.30 - 17.00 QA Unit versus Qualified Person
  • EC requirements for qualified person
  • Duties and responsibilities of the qualified person
  • Qualified person and FDA requirements
17.00 - 17.30 Discussion

 

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GMP Conferences by Topics

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