GMP and Validation for Equipment Suppliers

Place
Online training
Site visit
Dates
Next Dates
In-house Available
Who should attend?
  • Design engineers
  • Service engineers
  • Mechanical engineers
  • Electrical engineers
  • Project managers
  • Business development managers

Summary

Deep dive into the challenges of EU GMPs, equipment IQ/OQ validation and performance qualification led by our acclaimed trainer and GMP expert with over 30 years of experience in the pharmaceutical industry.

Learning Objectives

  • GPM expectations & documentations Issues
  • Overview of GMP chapters
  • Dos and Don'ts during equipment fabrication
  • Role of Validation Masterplan and V model
  • Customer expectations regarding FAT
  • Factory acceptance and site acceptance tests

Key Topics

  • EU GMP requirements
  • GMP documentation issues
  • Validation activities and expectations for equipment suppliers
  • Factory acceptance and site acceptance tests
  • Installation, Operational and Performance Qualification

Programme

  • Hours of interactive online learning
  • Training materials in digital format
  • All delegates will receive digital and LinkedIn certificates
Request Full Agenda

Trainers

Rob Walker

Director

Rob Walker GMP Consultancy Limited

United Kingdom

 

Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry. He has over 30-year experience in the Pharmaceutical industry including 25 years as a Qualified Person. After 16 years in senior management at CP Pharmaceuticals, the last 7 as Quality Director, he is now a director of his own GMP consultancy company operating across the Global Market.

Rob has extensive GMP Manufacturing and Quality experience covering a wide range of dosage forms, in particular aseptic sterile products, and has successfully managed GMP inspections by MHRA and FDA for primary and secondary manufacturing in the UK and overseas. He has performed GMP audits and training encompassing all elements of the global pharmaceutical supply chain.

A member of a number of pharmaceutical industry professional organizations, Rob has delivered numerous presentations to Industry/Regulatory forums in both the EU and the USA on current GMP issues. He has edited technical reports for professional bodies on steam sterilization, and contributed to pharmaceutical industry monographs on media fills and integrity testing of sterile products. He has also represented the UK Pharmaceutical Industry in regulatory meetings in the EU and USA.

Rob Walker

Director

Rob Walker GMP Consultancy Limited

United Kingdom

 

Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry. He has over 30-year experience in the Pharmaceutical industry including 25 years as a Qualified Person. After 16 years in senior management at CP Pharmaceuticals, the last 7 as Quality Director, he is now a director of his own GMP consultancy company operating across the Global Market.

Rob has extensive GMP Manufacturing and Quality experience covering a wide range of dosage forms, in particular aseptic sterile products, and has successfully managed GMP inspections by MHRA and FDA for primary and secondary manufacturing in the UK and overseas. He has performed GMP audits and training encompassing all elements of the global pharmaceutical supply chain.

A member of a number of pharmaceutical industry professional organizations, Rob has delivered numerous presentations to Industry/Regulatory forums in both the EU and the USA on current GMP issues. He has edited technical reports for professional bodies on steam sterilization, and contributed to pharmaceutical industry monographs on media fills and integrity testing of sterile products. He has also represented the UK Pharmaceutical Industry in regulatory meetings in the EU and USA.

Tour info

Price per Delegate (EUR)

Online Training

1350.00

Public Training

Register Now

Testimonials

Request Full Agenda

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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543