PLEASE NOTE! This program content was originally developed on a construction project (and in consultation with the pharma industry) by a team of scientists, chemical engineers and validation engineers working for an engineering consultancy to rapidly train its own staff to populate an equipment validation protocol.

This program is highly specialized so you MUST have one of the following:

• You are a plumber/pipefitter/pipe welder (e.g. high purity pipe fitter and orbital welder) / site-foreman / instrument technician (i.e. you can interpret technical drawings, especially P&IDs and pipe skids) and you are fed up working outside on freezing cold construction sites.
  Or
• You have 1 year or more of GMP manufacturing experience or have a recognized GMP qualification.
  Or
• You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, etc.
  Or
• You work in Quality Assurance or Quality Control in the pharma/medtech industry and are worried about having to sign off on validation documents you don’t fully understand!
  Or
• You are a chemical / process / petroleum / project / mechanical, etc engineer or a laboratory scientist and want to move into a validation role or learn how to correctly populate an equipment validation protocol.
  Or
• You already work in validation (e.g. mechanical contracting company carrying out high-purity pipework installations) but have no formal training on IQ OQ PQ equipment validation protocols.

You could retrain for the following roles;

• Validation Technician – Some pharma companies call this role:
  • CQV Specialist
  • C&Q Specialist
  • Associate QA Validation Specialist
  • C&Q Junior Project Manager
  • Equipment & Process Validation Specialist
  • QA Validation Associate
  • QA Validation Specialist
• Validation Team Member

With validation roles, you could work directly for a pharmaceutical company on in-house projects or work for an engineering consultancy or engineering contractor as part of a project team on large capital projects.

• How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
• How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics & Electrical Loop Drawings used to define the equipment system.
• How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this.
• The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do based on the User Requirement Specifications).
• How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol.
• How to qualify equipment, instruments and piping systems, and automation controls.
• How to document all of these steps in a 100 page plus equipment validation protocol which you will develop as your end of module assignment.

• Complete 5 Equipment Validation Protocol workshops on the following to prepare you to populate your own protocol:
  • Component Level Impact Assessment
  • Equipment Installation Verification
  • Piping Installation Verification
  • Instrument Installation Verification
  • Functional Verification Test
• Complete 8-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.

The protocol will detail the following elements;

• Product characteristics – showing what your system is looking to achieve/produce
• Production equipment – detailing the equipment necessary
• Test scripts and methods – telling you the steps involved in conducting a test
• Test parameters and acceptance criteria – defining acceptable test results
• Test checksheets – documenting and recording the test results
• Final approval – documenting that the validation process has been successfully carried out