Definitive Validation Manual.

The Definitive Validation Manual, was written because FDA Compliant, could see there was, is, and will be for a considerable time, a lack of skilled validation staff.   There is simply not enough experienced validation persons available.  Validation being a relatively young subject, the established colleges and universities  have not managed to set up courses covering validation as a separate subject, yet they have failed to integrate into existing courses knowledge of GAMP 4, or GMP's, or 21 CFR Part 11, or EMEA 726-2004. People are taking various degree courses for employment in the pharmaceutical and medical device manufacturing industry,  and arriving in production plants with little or no comprehension of FDA or MHRA rules and requirements or any validation expertise.  

Validation is the number one priority in these plants, fall down on your validation and the regulators (FDA / MHRA / EMEA) can fine you, remove your approval to manufacture, or even close you down. Losing your manufacturing rights for a drug that has taken hundreds of millions to develop, is catastrophic, even to the major international companies. Good validation ensures that this does not happen. Validation is a mixture of skills, and the Definitive Validation Manual  is designed to interlink with your existing skills and add the required mix of Quality, Instrument, electrical and mechanical knowledge to enable you to work as a validation technician or engineer or consultant in the pharmaceutical or biotechnological or API or Medical Device, industries. In validation you are not designing, you are verifying that equipment or installation and use conform to certain standards. This involves authoring a document train that starts with the URS follows with IQ / OQ and usually finishes with the PQ, normally difficult and complex documents - but in your case - they are all on the manual Definitive Validation Manual DVD, ready for you to download. Using the manual is a great way to receive training while maintaining  full time employment, and to feel confident that the manual has the answers or can point to where the answers are for any validation problem you may run into.

DEFINITIVE VALIDATION MANUAL.