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In-house Training Programme

 
 

Qualification and Validation of Equipment and Processes in Laboratories and Manufacturing

 
     
 
When What
Day 1  
08.00 - 08.30  Welcome, Introduction
08.30 - 10.00 Regulatory Requirements for Qualification
  • Europe
  • FDA
  • Harmonisation (PIC/S, ICH)
  • Definitions
10.00 - 10.15 Break
10.15 - 11.15 Documents required, Document Management
  • Validation Policy
  • Validation Master plan
  • SOPs
  • Documents for Performance
  • Responsibilities
  • Validation Team
11.15 - 11.30 Break
11.30 - 13.00  General Aspects on Qualification
  • Risk Analysis as a Basis for Qualification
  • URS/FDS, DQ, FAT, IQ, SAT, OQ, PQ
  • Qualification of Existing Equipment
  • Requalification
13.00 - 14.00 Lunch
13.45 - 15.00 Performance of Qualification
  • How to Write a Qualification Protocol (Content)
  • Performance of Qualification
  • Tests
  • Data and Data Integrity
  • How to Write a Qualification Report (Content)
15.15 - 15.30 Break
15.30 - 16.45 Support of Qualification and Validation
  • Quality Management System
  • Calibration/Maintenace
  • Change Management
  • Audit of Qualification and Validation
  • Process Verification
16.45 - 17.15 Discussion
 
Day 2  
8.30 - 10.00 Performance of Validation
  • Risk Analysis as a Basis for Validation
  • How to Write a Validation Protocol (Content)
  • Performance of Validation
  • Prospective/concurrent/retrospective
  • Tests to be Executed
  • Data and Data Integrity
  • How to Write a Validation Report (Content)
  • Validation Life Cycle
10.00 - 10.15 Break
10.15 - 11.15 Performance of Validation of Analytical Methods
  • Content and Implementation
  • SOP´s necessary for Validation
  • How to Write a Validation Protocol
  • Methodology and Performance
  • How to write a Validation Report
  • Prerequisites for Validation
11.15 - 11.30 Break
11.30 - 12.45 Cleaning Validation
  • Requirements of the EMA Guidelines
  • Requirements of the ISPE Guideline
  • The Change of Philosophy
  • How to Evaluate the PDE Values
12.45 - 13.45 Lunch
13.45 - 14.45 External Qualification and Validation
  • Contract Manufacturer
  • Qualification/Validation by Supplier
14.45 - 15.30 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.

 

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