Basic GMP Course Regulatory and GMP Requirements for Pharmaceutical Companies

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 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

8.00 - 8.30 Welcome, Introduction, Presentation of the Speaker
8.30 - 9.30 Regulations in Europe
  • Directives
  • Guidelines
  • Notices
Regulations in the USA
  • CFR
  • Guidances
  • FOI
Harmonised Regulations
  • WHO
  • PIC
  • ICH
  • GHTF
  • ISO
9.30 - 10.45 GMP in Manufacturing
  • Quality of Starting Material
  • Production Process
  • Packaging and Storage
  • Contract Manufacturing
  • Responsibility
10.45 - 11.00 Break
11.00 - 12.15 GMP in Quality Control
  • Duties of Quality Control
  • Differences Between Europe And USA
  • Qualified Person
  • Validation of Analytical Methods
  • Performance of Analytical Methods
12.15 - 13.15 Lunch
13.15 - 14.30 Documentation
  • SOPs
  • Batch Documentation
  • Quality Control Documentation
  • GMP-Based Documentation
  • GMP Relevant Documents
  • Archiving
14.30 - 14.45 Break
14.45 - 15.45 Qualification and Validation
  • Definition and Differences
  • Validation Master Plan
  • Validation Team/Performance of Validation
  • Responsibilities
15.45 - 16.45 Change Management
  • Deviation
  • Change
  • Definition and Differences
  • Out of Specification
  • SOP
16.45 - 17.15 Training and Self-Inspection
  • Performance of Training
  • Performance of Self-Inspections
  • SOP
  • Documentation

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK