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In-house Training Programme

 
 

Pharmaceutical Quality Systems

 
     
 
When What
8.00 - 8.30  Welcome, Introduction, Presentation of the Speaker
08.30 - 09.30 GMP-Regulations and GMP-Requirements Applying to a QA Unit
  • Europe
  • FDA
  • Harmonised Requirements
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 - 11.45  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
11.45 - 12.45 Documentation of the Quality System
  • SOPs
  • Quality policy
  • Quality manual
  • QA documents in general
12.45 - 13.45 Lunch
12.45 - 13.45  Elements of a Quality Assurance System
  • Qualification / validation
  • OOS
  • Deviation / Change control
  • Auditing
  • Training etc.
13.45 - 14.45 Break
15.00 - 16.00 QA-System in Research and Development
  • QA system in research
  • QA system in development
  • Project management
  • Connection of R. A. D. to production
16.00 - 16.30 Documentation and Archiving
  • Requirements for documentation and archiving
  • Time for Archiving
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
 
 
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.

 

 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Microbiology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Validation
 Medical Devices
 GMP Basic Training Courses
 Packaging