CORPORATE VALIDATION MANUAL.
Corporate Validation Manual Scope.
This Corporate Validation Manual (CVM) is supplied loaded to a memory
stick (MS) and complete with the attachments that are listed in the
graphics below. These high quality documents and protocols are all
constructed in Microsoft Word. Each document is preceded by an SOP
which prompts you through the procedure of populating and then
customizing the template, into your own bespoke company document.
This CVM has real documents, detailed, compliant and interactive, but
most of all - Highly Cost Effective. These document have evolved
through over thirty years of joint validation expertise, they will free
up a lot of your time and enable you to deliver your validation projects
and tasks on time.
For the validation professional, this corporate validation manual is an extremely useful
tool, for the new comer in validation, it gives a huge boost to
confidence and actually makes you look good. To have this material on
hand is incredible and to be able to download and populate an IQ in
minutes, or six IQ’s in an hour, is quite awesome. Remembering always
that these are the best FDA Compliant document templates available
anywhere.
If you have background knowledge in pharmaceuticals and are reasonably
competent, the Corporate Validation Manual will do the rest for you. If
you are in the Pharmaceutical / Biotechnological / API / Medical Device,
industries or whether your in any of the engineering streams that are
involved with these industries, the Corporate Validation Manual will enable you
to:-
- Run large validation projects.
- Promptly produce compliance documentation.
- Get started in pharmaceutical validation.
- Gain promotion in the industry.
- Become dual skilled.
- Get into the highest paid section of the industry.
The cost of the FDA Compliant, Corporate Validation Manual, will be recouped in the first few weeks, it will then go on to show a very healthy return on your original investment.
An investment that you will never ever regret.
Corporate Validation Manual CHAPTER 1 TO 13 HEADINGS.
Corporate Validation Manual Usage.
It would appear the established colleges have not managed to establish validation as a separate subject, yet they have been slow to integrate into existing courses knowledge of GAMP 3/4/5, or GMP's, or 21 CFR Part 11, or EMEA 726-2004 Degree qualified persons looking for employment in the pharmaceutical and medical device manufacturing industry arrive in production plants with little or no comprehension of FDA or MHRA or WHO rules and requirements.
Validation is the number one priority in these plants, fall down on your validation and the regulators (FDA / MHRA / EMEA/ WHO) 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 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 Corporate 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 this Corporate Validation manual has the answers or can point to where the answers are for any validation problem you may run into.
Appended Validation Protocols
Appended Validation Test Scripts.
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User Requirements Specification Template
$115.00
The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for. It uses three levels of User Requirements Specification Template (URS), URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. It can be used on mechanical, electrical and software controlled, monitored or driven systems.
Corporate Validation Manual $1,160.00
This definitive 1000 + page (including all attachments) Corporate Validation Manual arrives with you in USB memory stick format, this enables you at any time to download protocol or test-scrips documents and quickly edit them into company bespoke documents. In fact there are over $3,500.00 worth of superb documents, that form attachments to the DVM manual, which can be instantly copied. Once copied, the unique document interactive editing, allows you to produce high quality bespoke company documents; Such as the Validation Plan Template or the equally ubiquitous User requirements Specification template Design Qualification (DQ); in a few hours. The cost of the Definitive Validation Manual, will be recouped in the first few weeks of use. It will then go on to show a massive return on your original investment.