Continuing Professional Development in Validation Science

Program Overview

This one-year Validation Science program provides a level 7 qualification for individuals seeking employment in the biopharmaceutical, pharmaceutical, and medical device industries. Delivered through a blended approach of online modules, industrial seminars, and workshops, the program includes modules on Introduction to Validation and Validation Science, covering topics such as GMP, process validation, risk management, and analytical method validation. Assessment is through industrial case studies, assignments, and online exams, and extensive career services and support are provided to enhance employability in the validation field.

Program Outline

Degree Overview:

This program in Validation Science provides a level 7 qualification in Validation Science over one year for individuals who are seeking to up-skill or cross-skill in order to gain suitable employment in sectors such as biopharmaceutical, pharmaceutical and medical device industries. This program targets employment roles in production/manufacturing, quality assurance, regulatory affairs, commissioning, qualification, validation and operation roles within pharmaceutical/biotechnology/medical device manufacturing companies. This is an industrially focused course where students gain valuable knowledge and key skills in subject areas pertinent to working in highly regulated manufacturing environments such as GMP, Quality and Validation. The importance of validation of equipment, plant, utilities, processes and procedures in industry will be shown to be an essential approach to consistently producing products of the intended quality.

Outline:

This one-year program is delivered over two semesters. The first module, Introduction to Validation, introduces key concepts related to working within a GMP environment and the second module (Validation Science) gives the learner a critical understanding of all aspects involved in process validation. Both modules are delivered through a blended approach of online delivery of material content, industrial supported seminars, industrial led webinars and industrial championed workshops. The student will gain an insight of the increasing regulatory requirements relevant to the biomedical, pharmaceutical and biopharmaceutical industry. The following topics will be delivered:

• Requirements of cGMP, QA, GMP, and Quality Control as interrelated aspects of Quality Management.
• Quality Assurance aspects.
• Data Integrity
• Quality Audits.
• Laboratory Management Systems.
• Process Control and Product Release Strategies.
• CM2012: Validation Science (5 credits)
• Validation Lifecycle EU and FDA regulations and guidelines.
• Process Validation Quality by design, establishing a strategy for process control.
Commissioning and qualification of processes and utilities. Process Performance Qualification Continued Process Verification. Prospective, concurrent and retrospective approaches in process validation. Revalidation.
• Risk Management in Process Validation Review of industrially recognised risk management guidelines and application of tools such as PHA, FMECA and Fault Tree Analysis.
• Validation of Pharmaceuticals and Biopharmaceuticals Validation of APIs, solid dosage forms, inhalation aerosols.
Sterilisation and aseptic process validation.
• Validation of Medical Devices Lifecycle approach to validation with a focus on medical devices.
Validation vs. verification. Validation of software controlling a medical device.
• Computer and Automation Validation Compliance with 21 CFR Part 11 and use of GAMP guidelines.
Confirmation of data integrity.
• Cleaning Validation Methodologies used to prove the effectiveness of equipment cleaning processes and procedures in the manufacturing process.
• Validation Documentation Preparation and review of validation documents such as the User Requirement Specification, Validation Master Plan, Validation Protocol, Validation Report.

Assessment:

The course is examined through a mixture of continuous assessments which includes industrial themed case studies, individual-based assignments and online examinations of material content.

Teaching:

The course is delivered through a blended approach of online delivery of material content, industrial supported seminars, industrial led webinars and industrial championed workshops.

Careers:

At the beginning of the course the 1st workshop that the students takes is a career professional development (CPD) workshop. This aims to highlight the skills required on completion of the programme in the recruitment and selection process for employment in the sectors identified. In addition, the industrial partners offer advice on career prospects and pathways in the validation field. Networking opportunities are given as part of the workshop/seminars held throughout the programme.

Other:

The course consists of two 5 credit modules. All lectures are delivered online with each module containing six units of lecture topics. On completion of each unit the student will be required to complete a series of multiple choice questions (MCQ). Progression to the next unit of lectures is based on achieving an 80% grade in the MCQ. In addition, a series of workshops delivered by industry will be provided and the student will be required to submit an assignment for these. Finally, several industry webinars will also be delivered as well as further reading material and directed study.

€1250