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In-house Training Programme

 
 

FDA and EU GMP Compliance in analytical Laboratories

 
     
 
When What
Day 1  
08.30 - 09.00 Welcome, Introduction, Presentation of the Speaker
9.00 - 10.30 Regulatory Requirements in the Pharmaceutical Industry 
  • FDA CFR Parts 200, 600 
  • GMP Regulation, WHO, Europe Duties of the Quality Control Department: an Overview 
  • Definitions differences between the Requirements 
  • Differences between Quality Control and Quality Assurance
10.30 - 10.45  Break
10.45 - 11.45 Documental Requirements on Qualification and Validation
  • Qualification/Validation Policy 
  • Validation Master Plan 
  • Documents for the Performance of Qualification/Validation 
  • SOPs 
  • Responsibilities 
  • Presumption for Qualification/Validation 
  • Qualification/Validation Report
11.45 - 13.00 Validation of Analytical Methods 
  • ICH Guideline 
  • SOP's necessary for Validation 
  • How to Write a Validation Plan 
  • Methodology and Performance 
  • How to write a Validation Report 
  • Presumption for Validation
13.00 - 14.00  Lunch
14.00 - 15.15 Out of Specification (OOS) 
  • The Barr Case 
  • FDA Guideline for OOS 
  • SOP for OOS Working on OOS 
  • Failure Investigation 
  • Implementation of Other Departments
15.15 - 15.30  Break
15.30 - 16.30 Sampling 
  • Sampling Plan 
  • Performance of Sampling 
  • Pitfalls and Failures of Sampling 
  • SOP for Sampling 
  • What to Sample
16.30 - 17.15 Batch Release
  • SOP for Batch Release
  • Basic Documents for Release
  • Responsibilities
  • Performance of Release
17.15 - 17.45 Discussion of Day 1
   
Day 2  
09.00 - 10.15 Stability Testing
  • Stability Testing Plan
  • Different Kinds of Testing
  • Ongoing Testing Performance of Testing Stability Report
10.15 - 10.30 Break
10.30 - 11.45 SOP/Documentation
  • How to Write a SOP
  • Content of a SOP
  • Nuts and Bolts of SOPs
  • Distribution and Maintenance of Documents
  • Archiving
11.45 - 13.00 Selfinspection/Auditing
  • Inspection Program
  • Inspection Plan
  • Performance of an Inspection
  • Dos and Don'ts
  • Supervision of External Contractors
  • Inspection Report Qualification of Auditors
13.00 - 14.00 Lunch
14.00 - 15.00 Training Training Plan
  • SOP for Training
  • Performance of Training
15.00 - 15.30 Discussion of the Seminar
 
 
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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