InStep Training is an International Training & Consultancy Provider delivering continuous Human Resource performance improvement.

We link people, technology and organisations improving operating effectiveness and optimizing business processes - Step by Step!

We provide full circle training, from project design through to project delivery and follow-up support

 

Special Offer!

Cold Calling

Confident Public Speaking

Testimonial

"I was totally satisfied with the course, contents and presentation. The course was very interesting and useful to me. Also the hand out folder and slides were very useful. Very pleased, Thank You Paul"

 
  



A Helm Global Group Company
 




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Validation

Validation can be extremely time consuming and require enormous resources. However, it can be simplified into the requirements across five General Areas: Process, Methods, Cleaning, Utilities and Computer. Once the fundamentals are understood against the usual what, when, why, how and where, the concepts are pretty plain sailing.

General Areas:

  • The Plan, Policy, Methods
  • The Documentation, Records, Results
  • The Qualification Trail
  • Change Control
  • Water & CIP Systems
  • Software Systems
  • Sources of Contamination
  • HVAC
  • The 'People' System
  • The Documentation Trail
  • A Reporting System
  • Approvals at all stages
  • The Technology Transfer Process
What is practically required?
  • Completing the Work/Reviews
  • Design
  • Equipment
  • Instruments
  • Services
  • Methods
  • Materials
  • Process
  • Documentation/Records
  • Cleaning
  • Preventative Systems
  • Critical Lists

Contact us with your specific requirements.






 
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