For more information,
email eurcoval.gotham@ntlworld.com
The requirements to validate facilities, equipment and processes used in the manufacture of medicinal products have been around since the mid-1970s. In the intervening years these requirements have gained an enhanced profile in consistent and safer processes for the manufacture of pharmaceutical products which do not place patients at risk because of inadequate safety, quality or efficacy. It is estimated that the cost of taking validation through installation qualification (IQ) and operational qualification (OQ) is 1.8 to 2.5% of facility capital value whilst performance qualification (PQ) and process validation (PV) can increase this to over 6%.
The US regulatory authority the FDA defines validation as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes”. It is now a regulatory requirement within the pharmaceutical industry to carry out validation of processes, computer/control systems, equipment, utilities and facilities and a pharmaceutical company setting up in a green field site would currently require 10% of its overall budget for validation activities. The validation activities involved when establishing a company and the on-going validation/revalidation studies necessitate companies having dedicated validation departments which employ personnel who require minimal training and are experienced/skilled in the area of validation.
The impact of validation personnel on a company’s turnover can therefore be significant both as a saving (when it all goes right) or a cost (when it all goes wrong).
The idea of ‘certification’ of validation professionals has been discussed since early 2000, approximately the same time as a number of like-minded industrialists and academics came together to discuss the possibility of a higher degree in this area.
A collaborative Steering Group was formed which after some interesting and prolonged meetings discussing various aspects and exact meanings of commonly used terminologies in validation led to an agreed outline curriculum. Unanimous agreement had already been obtained in that any qualification offered should be at the postgraduate level and that the course should be aimed at scientists, engineers and other professionals working in the pharmaceutical, biotechnological and health-care related industries.
A market survey in early 2002 indicated that such a course, offered in the distance-learning mode with associated residential periods would be viable, the approach of ‘how to do it’ as well as ‘what to do’ was especially well received.
As an outcome of the survey a small group from the original steering group set up the European College of Validation (Eurcoval) in order to further the aims of the steering group. Members of Eurcoval have substantial experience in the organisation and delivery of postgraduate distance learning programmes, having worked together as a team over many years, and are supported in course delivery by recognised experts in the field of validation from European companies and consultancies.
Around about this time the School of Chemistry at the Dublin Institute of Chemistry (DIT) was also exhibiting an interest in developing a part-time postgraduate course in validation to expand its portfolio of masters’ courses. A meeting between Eurcoval and DIT confirmed similar aims and outlooks for development and in March 2003 a collaborative agreement was signed whereby Eurcoval would develop a course in the distance-learning mode and DIT a mapped course in the part-time mode.
The Eurcoval distance learning MSc/PGDip in Pharmaceutical Validation was validated by DIT in 2004 such that the first intake with students from companies such as Astra-Zeneca, Bio Products Laboratory, Cardinal Health and Organon occurred in January 2005. Since that time students have registered from many other national and international companies and have attended residential blocks from countries such as Malta and Saudi Arabia.
The philosophy underpinning both courses ensures that the programme delivers, in essence, skilled competent personnel whose skills and experiences are concerned with the application of validation within the pharmaceutical industries. These skills are most often acquired in industry rather than through formal study. Validation offers an opportunity to acquire a diverse set of skills across many disciplines such as chemistry, pharmaceutical technology, engineering etc. The part time programme provides an opportunity to acquire these skills within the geographical surrounds of Dublin whilst the distance learning course expands this sphere of influence across the UK, Europe and beyond. The emphasis is on a practical problem solving approach to validation drawing on industrial case studies to develop required skills, and to illustrate underlying principles. The graduates from these programmes will be qualified to employ their skills not only in the validation areas but will also have the flexibility to transfer these skills to other cognate sectors of the pharmaceutical industry.
(a) provide a distance learning programme which allows science and engineering graduates to develop the necessary knowledge and skills to integrate quickly into the role of validation engineer or manager,
(b) present a detailed introduction to each module topic, supported by relevant practical validation knowledge based on proven theory and current regulations,
(c) provide a unique opportunity for personnel already employed in this highly specialised area of the industry to obtain a relevant postgraduate qualification over two or more years on a distance learning basis,
(d) deliver high quality industrially relevant education and training by experts from academia and industry,
(e) provide appropriate assessments and assignments in order to enhance, reinforce and test learning,
(f) make available modules and topics suitable for continuing professional development,
(g) deliver a programme which will enable graduates to work effectively with a range of professionals in solving plant operating problems,
(h) enhance the student’s ability to exploit work-based and self directed learning,
(i) develop research skills.
The Eurcoval course is distance learning and runs over two years. The Postgraduate Diploma (18 months, 90 ECTS credits) comprises 12 modules and 4 residential blocks. An additional research project (6 months, 30 ECTS credits) is required for the MSc award.
The Diploma commences in January each year.
Each Diploma module comprises 100 hours of total student effort made up of 60 hours spent on distance learning material, guided study and attendance at a residential block and 40 hours for the preparation of assessments. Each module has been allocated 9 hours of contact split between two residential blocks.
Candidates can exit the course after satisfactory completion of the twelve Diploma modules with the award of a Postgraduate Diploma in Pharmaceutical validation Technology or they may proceed to the MSc.
The Diploma modules have individual module teams comprised of academics and industrialists with the lead industrialist/consultant acting as Module Leader. Students receive a module book for each module written by the module team. This material is supported by provided textbooks, journal articles and other appropriate sources.
The content of the modules aims to equip the student with the knowledge and experience to successfully validate the wide rage of facilities, utilities, processes, procedures and equipment used in the pharmaceutical and biopharmaceutical industries.
To date the organisers are pleased to note that the feedback from all the students has been extremely positive, thus demonstrating that the course meets the identified need of the pharmaceutical, biotechnology and related health care industries to have a validated postgraduate programme for personnel working in the validation environment such that their expertise can be enhanced and their careers progressed.
Finally I would like to thank everyone who has given their time willingly to bring this programme to a successful fruition.