VALIDATION ACADEMY.


A validation Academy graphic depicting the Edinburgh city skyline.o


An Insite to the world of Validation.

The Validation Academy can open opportunities that command the highest salary levels in the pharmaceutical / biotechnical / API / medical device, industries, and yet does not demand the highest level of academic achievement. The emphasis is more on the side of experience and practicality. Browse through these attached job vacancies and you can see where the emphasis on candidate suitability is place. These are typical of the multitude of opportunities that the Validation Academy can make accessable to your paticular skill set.  The situation vacant, advertiser is not laying down a demand for wall to wall qualifications, but is stipulating an in depth knowledge of validation as a requisite for the vacancy.  This is quite the norm for the industry. Had the vacancy been for the laboratory or process side of the business, the salary offered would command at least a PHD level of qualification.


Validation started in the aircraft industry back in the 1950’s, it came about simply because of the atrocious reliability of the then current aircraft. Liability law was growing exponentially and people in the aircraft industry suddenly realized that one accident was unique, two accidents was improper, use or manufacture. QA was born, every manufacturing process was documented. The process was then validated, all parts of the process were calibrated, validated and verified. Nothing could be used that was not a known item with certification of its component parts and final specification. Every company had to write a Company Exposition, which was a precursor to an ISO Quality Management Procedure.  Quality was inspected into every process from the mining of the basic ores to the painting of finished aircraft, everything carried release certification. No release certification, and the item could never be used.  Passengers killed, started to fall, aircraft lost, started to fall. Now every single thing that went wrong was subjected to detailed investigation (at times regardless of cost). There was no place to hide skeletons, if mistakes had been made during production or operation they were made public. Companies closed or conformed.


The pharmaceutical industry never went through this stage and have never come close to the degree of quality control that is standard practice in the aviation industry. This is why there is still a great call for validation staff and validation opportunities abound. The industry is far from being properly under control. The Comet disasters in the 1960’s shook up the entire aircraft industry when around 200 people were killed. The Thalidomide disaster around the same time caused severe malformities to 10,000 infants, and resulted in a call for further tests in future, but no call for more exacting manufacturing procedures.

 

The Validation Academy was formed to introduce skilled qualified people to the additional skills that the day to day operation of validation requirements demands.  As consultants just about everywhere we go we are asked by all levels and skills of staff if there is a course that can be taken that will give you the validation skills set.  It is the intension that the Validation Academy will slowly introduce such a service.


Can you prove these validation salaries?

We could, but the best way to convince yourself is to ring the agencies that are advertising validation vacancies. A biologist with a basic degree or who starts in a laboratory straight from school (with A levels) can expect to earn £16/19K, (€23/27K), ($27/33K) per year, in a permanent position. In a contract position around £10/14/hour, (€14/20/hour), ($17/24/hour). With Validation Academy Training Center, training they would immediately jump to £24/28/hour, (€35/41/hour), ($41/48/hour), quite substantial extra income. After one years field experience they could earn an easy £32/36/hour, (€46/52/hour), ($55/62/hour). After that it really depends on equipment experience, if a company wants specialized people then they have to, and do, pay the going rate. The same applies to persons who enter the validation field from an engineering background (mechanical / electrical / instrument / electronic / software / IT). Fitters with a few years experience are ideal training material.


Why such high rates?

Validation is all about experience and know how. When pharmaceutical companies start, move, alter, modify in any way, equipment (all equipment) that is used to produce their product, then the regulators (FDA, HMRA etc) demand, and will inspect to ensure, that all the equipment has been revalidated. This is time consuming and expensive for the companies, but no exceptions are given.  When a new plant is being built and approaching the production stage it often soaks up every contract validation engineer available in that area and sometimes in the surrounding countries. This has been the norm for many years and was vividly demonstrated in the early 2000's; in the explosive growth in, pharmaceutical manufacturing, in Ireland, which drew in validation staff from all over the world.


VALIDATION ACADEMY.


Validation Plan (Issue 10) -- $93.00

The Validation Plan (VP), is the starting point for any validation task, and 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 a mandated document with regulators and auditors.

While in the past validation was more focused on functions of procedures, recently the focus has progressed into infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by systems.



User Requirements Specification (Issue 8) -- $115.00

This document was designed to be used as a live document up until the DQ is completed and approved.  It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing.  A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules.  It can be used on mechanical, electrical and software controlled, monitored or driven systems.



Validation Risk Assessment (Issue 11) -- $125.00

This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities. The VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).



Design Qualification (Issue 5) -- $115.00

The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.


………………………………………………… Validation Plan (Issue 10) -- $93.00

Installation Qualification.  (Issue 9.) -- $115.00