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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Quality Audits

Understanding the regulations leads to implementation and, ultimately, both internal and external audits of facilities against them. We believe in convergence of audit techniques to ensure that effort is concentrated toward overall audit success. We also believe in preparedness, ensuring facilities are at peak at all times. This means that should audits be required at short notice the facility can rest assured that it is ready. Our training covers a wide range of issues, each detailed and enjoyable. Each are built around your specific situation, bringing reality and focus to every session. Courses are structured to your requirement.

General Areas:

  • The FDA & Other Audit A to Z.
  • Audit Approaches
  • Audit Routes & Routine
  • Specific Audit CheckPoints, for example
    • Facilities
    • Organisation, Role & Responsibilities, Records
    • Methods, Specifications, Testing, Approval & Release
    • Raw Materials, Certification and Acceptance
    • Processing & Process Control, NDA/DMF Comparisons
    • Equipment, Utilities, Design & 'Fit for Purpose'
    • Complaint & 'Outside Acceptance' Criteria. Annual Report.
    • Materials, Packaging, Labelling, Storage & Designations
    • Documentation Linkages & 'Fit for Purpose' & Deviation Systems
  • Basically, we cover all the requirements. We hope to cover all the 'TrapDoors'.

Contact us with your specific requirements.






 
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