VALIDATION TRAINING.


This graphic depics a validation training customer area.

Introduction to Validation Training.

Validation training is mandated in GMP regulations so enforcing all manufacturers to provide training for personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.

 

Beside the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept. 

 

Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training.  Visitors or untrained personnel should, preferably, not be taken into the production and Quality Control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised. 

 

The concept of Quality Assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.


VALIDATION TRAINING.


Computer Combined IQ-OQ-PQ (Issue 3) -- $159.00

This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand-alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.

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Computer User Requirements Specification (Issue 5.) -- $115.00

The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved.

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Computer Validation Master Plan (Issue 5.) -- $115.00

The Computer Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.

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Computer Validation Package 1. (Issue1) -- $675.00

This computer validation is suitable for all major validation projects and contains the under-listed interactive documents. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

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Computer Validation Package 2. (Issue 3.) -- $580.00

The complete chain of regulatory required documentation; for the validation of a computer system, minus the VMP. This Validation Package contains one of each of these documents: VP, URS, DQ, VRA, IQ, OQ, PQ.

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