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Module 4. Project planning
Aims
The aim of this module is to provide the candidate with an understanding of how to plan the validation activities in projects. Validation Master Plans (VMP), execution of planning and methods of tracking validation projects will be included in this module.
Learning outcomes
On completion of this module the candidate will be able to:
- understand how the Validation Master Plan (VMP) relates to the project plan, and the benefits in creating such a VMP.
- understand how to plan a validation project.
- be familiar with the content of and use of Validation Master Plans.
- understand the execution planning, including: resources, timescales/deadlines, costs.
- structure a total validation planning through some exercises.
Tutor information
Hugh Butcher
Hugh is part of the senior management of SciTech Engineering as their Validation & Regulatory Compliance Director.
He has over 25 years Regulatory Affairs and Project Management experience in pharmaceuticals. Qualified in Industrial Pharmaceutical Studies, he has been retained by many pharmaceutical organisations as a consultant. Since joining the Engineering and Contracting Sector 15 years ago, Mr. Butcher has managed teams of technical specialists on major pharmaceutical and biotechnology projects worldwide. A regular contributor to the advancement of this profession, Hugh presents papers at European ISPE events and has played a significant role in advising the European Commission.
Prior to joining SciTech Engineering Ltd., Hugh held a similar position with SembCorp Simon Carves and Fluor Daniel making a major contribution to pharmaceutical projects in the UK, Ireland and in mainland Europe. His activities included writing Validation Master Plans, GMP Audits and DQ, IQ, OQ Protocols as well as Project Management of the start-up of an aseptic clinical trials facility, GMP Consulting, qualification of revamped facilities etc.
With Beecham Pharmaceuticals (later GSK), he accumulated over 10 years experience of Penicillin and Cephalosporin manufacturing. This extended to all aspects of sensitizing antibiotic manufacture, from routine operating to taking part in regulatory compliance audits from the FDA and the UK MHRA regulatory bodies.