Qualification and Validation in Pharmaceutical Production

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 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 - 08.45 Welcome, Introduction
08.45 - 09.45 GMP-Basics and Pharmaceutical Regulations
  • Where do we find requirements related to and impacting on engineering work?
  • Specific requirement for plasma derived products
09.45 - 11.00 Specific Requirements and Terminology
  • Clean Room Grades
  • Deviation Management
  • Quality Risk Management
11.00 - 11.15 Break
11.45 - 12.30 Annex 15 on Qualification and Validation
  • Impact and Importance of CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters)
  • Validation Master Plan
12.30 - 13.30 Lunch Break
13.30 - 14.00 User Requirements Specifications / Functional Design Specifications
14.00 - 14.30 Preparation of a URS
14.30 - 15.45 Risk Analyses – a fundamental Requirement
15.45 - 16.00 Break
16.00 - 16.45 Preparation of a Risk Analysis (Impact Analysis)
16.45 - 17.00 Room for further discussion and questions

 

  Content Day 2
8.30 - 10.00 Design Qualification /Design Review
09.15 - 09.45 Design Qualification
09.45 - 10.15 FAT / SAT (Commissioning)
10.15 - 10.30 Break
10.30 - 11.45 IQ / OQ / PQ
11.30 - 12.30 Preparation of a Qualification Plan
12.30 - 13.30 Lunch Break
13.30 - 14.45 Process Validation – Introduction to the regulatory requirements
14.45 - 15.15 Execution of the Qualification Plan, sharing experiences
12.30 - 13.30 Break
15.30 - 16.30 Cleaning Validation – Introduction to the regulatory requirements
16.30 - 17.00 Room for Questions and further discussion - Close-Out

 

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