ECA - European Compliance Academy - Inhouse Training Programme

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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.