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In-house Training Programme

 
 

ICH Q7 Compliance

 
     
 
When What
Day 1  
8.00 – 8.30 Welcome and Introduction
8.30 – 10.00 Regulatory Requirements for the Manufacturing of the Active Pharmaceutical Ingredients
  • Structure of the Regulations
  • Europe
  • USA
  • Harmonisation
10.00 – 10.15 Break
10.15 – 12.15 The Quality Management System
  • Regulatory Requirements
  • FDA New View on QA-System
  • Maintenance of a QA-System
  • Main Points of a QA System
     -Responsibility of the management
    - Change
    - OOS
    - Deviation
    - Complaints
    - Training
  • Communication with the Contractor
12.15 – 13.15 Lunch
13.15 – 14.30 Risk Management, ICH Q 9
  • Methods, Content of ICH Q 9
  • Performance
  • Documentation
  • Input on QA-System
  • DIN EN ISO 14971
14.30 – 16.30 Qualification/Validation
  • Regulatory Requirements
  • Qualification of Equipment
  • Documentation of Qualification
  • Retrospective Qualification
  • Requalification
  • Cleaning Validation
  • Validation of Processes
  • Documentation of Validation
  • Retrospective Validation
  • Revalidation
15.30 – 15.45 Break (in between)
16.00 – 17.30 Quality Control
  • Regulatory Requirements
  • Duties of QA based on GMP-Guideline
  • Performance of Testing
  • QC/QA versus Qualified Person
  • Validation of Analytical Methods
  • Stability / Retest
17.30 – 18.00 Final Discussion
   
Day 2  
8.00 – 8.30 Remarks, Questions; Proposals
8.30 – 9.30 Facility and Material Management
  • Qualification of Suppliers
  • Supervision of Suppliers
  • Maintenance of Equipment
    - Internal
    - External
  • Control of Incoming Materials
  • Storage
10.30 – 10.45 Break
10.45 – 12.45 Manufacturing of the API
  • Requirements for Manufacturing
  • Starting Materials
  • In Process Controls
  • PAT (Process Analytical Technology)
  • Mixing up of Different Batches
  • Reprocessing
  • Rework
12.45 – 13.45 Lunch
13.45 – 14.45 GMP in Research and Development
  • Requirements for a Quality Management System
  • Implementing of a Quality Management System
  • Documentation
    - CTD
    - DMF
14.45 - 16.00 Documentation
  • Regulatory Requirements
  • Documentation of the QA System
  • Documentation in
    - Production
    - Quality Control
    - Engineering
    - Quality Unit
    - Annual Product Review
15.15 – 15.30 Break (in between)
16.00 – 17.15 Auditing and Self- Inspection
  • Regulatory Requirements
  • Auditprogram
  • Auditplan
  • Performance of Auditing
  • Supervision of Contract Manufacturer
  • Supervision of Manufacturer for Starting Materials
  • Nuts and Bolts of an Audit
17.15 – 17.45 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.

 

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