course information

Overview

Course structure

Modules

Eligibility of applicants

Assessment procedures

Course organisation

Course certification

Course fee

Payment

Application Form 

Residential blocks

MSc in Pharmaceutical Validation Technology Course Overview

The mission statement of course is to provide a suitable learning experience to enable successful participants to become leading edge validators within the pharmaceutical and allied industries.  The course is run and administered by the European College of Validation Ltd in partnership with the Dublin Institute of Technology. This course is fully ratified through academic rigour and will provide successful delegates with a formal qualification equal in every way to the MSc degree awarded by other colleges or faculties. In addition the practical nature of the study will enhance tremendously your value to your company and the effectiveness of the validation processes in the workplace.

Structured as a modular distance learning course.

Qualification awarded by the Dublin Institute of Technology.

18 months continuous assessment for the diploma (by for example written assignments).

4 residential blocks for diploma (possibly at various European locations).

6 months to MSc, which comprises an in-house project.

Normal entry requirement would be a relevant first degree and vocational experience.

Experts from the validation industry are involved in the writing of module materials, in attendance at residential weeks and marking of assessments.

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Course structure

The course is distance learning and runs over 2 years. The PGDip (18 months) comprises 12 modules  and 4 residential blocks. An additional research project (6 months) is required for the MSc award.

Each Diploma module involves approximately 100 hours of study which is divided into:

• directed study (including residential blocks)
• preparation of assessments
• in-house assignments
• private study

It is expected that a mentor from the student’s organisation will be nominated to provide guidance for appropriate parts of the course.

Candidates may wish to exit the course after satisfactory completion of the 12 Diploma modules with the award of Postgraduate Diploma Pharmaceutical Validation Technology or they may proceed to the MSc.

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Modules

The twelve compulsory modules comprising the course are:

1. INTRODUCTION TO VALIDATION IN THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
2. REGULATORY AND DOCUMENTATION REQUIREMENTS
3. IMPACT AND RISK ASSESSMENT
4. PROJECT PLANNING
5. QUALIFICATION OF FACILITIES, UTILITIES, AND EQUIPMENT: GENERAL
6. QUALIFICATION OF FACILITIES, UTILITIES, AND EQUIPMENT: WATER SYSTEMS, HVAC, COMPRESSED AIR BMS
7. PRIMARY (API) PROCESS VALIDATION
8. SECONDARY PROCESS VALIDATION STERILE AND NON STERILE PROCESSES
9. SECONDARY PROCESS VALIDATION: BIOTECHNOLOGY PROCESSES
10. SECONDARY PROCESS VALIDATION: PACKAGING AND DISTRIBUTION
11. COMPUTER SYSTEM VALIDATION
12. CLEANING AND  ANALYTICAL METHOD VALIDATION

Students will receive a module book for each module, written by module teams drawn from experts in the subject area. This material will be supported by provided textbooks, journal articles and other appropriate sources.

The content of modules aims to equip the student with the knowledge and experience required to successfully validate the wide range of facilities, utilities, processes, procedures and equipment used in the pharmaceutical and biopharmaceutical industries.

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Eligibility of applicants

Applicants must be graduates or equivalent and/or have relevant practical and vocational experience.

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Assessment procedures

Students progress through the course will be monitored by a mixture of continuous assessment, written assignments, oral presentations and multiple choice questions depending on the requirements of each particular module.

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Course organisation

The course is run and administered by the European College of Validation in partnership with the Dublin Institute of Technology.

The course has been developed in co-operation with the following professional bodies:

• International Society for Pharmaceutical Engineers
• Institution of Mechanical Engineers

Each of these bodies is represented on the course advisory committee, which also comprises representatives from the industry.

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Course certification

On completion of the course, successful participants will be awarded a Postgraduate Diploma or MSc in Pharmaceutical Validation Technology by the Dublin Institute of Technology. 

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Course fee

£7500 per annum plus VAT for MSc.

(to include accommodation at residential blocks, all meals, module books and accompanying text books, papers, etc)

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Payment

Following acceptance of applicants onto the course, further details will be issued to effect the invoicing of course fees. Fees may be settled in four stage payments by prior agreement. There is an 'early bird' discount available for first year fees of 15% for those who apply by 1st December and make a payment by 4th January.

Application Form

Please fill out and submit the Application Form to be considered for a place, or contact us at the address at the top of this webpage.

Residential blocks

Residential blocks will normally be held in the South East England area (though other venues are under consideration).

The residential sessions will include specialist lectures, workshops, student presentations, industrial visits and course assessment by multiple choice questions.

Attendance at the residential blocks is a compulsory element of the course.

 PGDip COURSE CALENDAR

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