FDA and EU GMP Compliance in analytical Laboratories

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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

  Content Day 1
08.00 - 09.00 Welcome, Introduction, Presentation of the Speaker
09.00 - 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
 

Content 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

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