Supplying to Pharma and Medical Device Industry

Skills for those aiming to join the sector

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Ireland is home to fifteen of the world’s top twenty-five healthcare companies, employing over 40,000 people. This highly interactive two-day training course introduces learners to the Pharmaceutical and Medical Device sectors, equipping them with the knowledge and awareness required to move from general industry into these highly regulated environments. The course is delivered by expert tutors who guide learners through the principles that govern pharmaceutical and medical device manufacturing, highlighting both differences and opportunities compared with other industries. It also explores the valuable perspectives, transferable skills and problem-solving approaches that individual and companies from general industry can bring to the healthcare industry.

This course provides an overview of the principles, regulations and practices shaping pharmaceutical and medical device manufacturing. Key areas covered include:

Laws, regulations and guidelines across Europe, the US, Japan, Australia, Canada and globally (ICH Q7, CE Marking, EU GMPs, FDA cGMPs)
ISO 13485, ISO 9000, FDA QMSR (Part 820) and their interrelationships
CAPA and continuous improvement in line with ICH Q10
Hygiene, sterilisation, cleanroom operations, cleaning validation and the role of the Qualified Person
Validation principles and lifecycle: VMP, IQ, OQ, PQ, process design and characterisation
Computer systems and software validation (GAMP 5, EU GMP Annex 11, 21 CFR Part 11)
Laboratory systems validation and method validation
Risk management principles (ISO 14971, ICH Q9)
Good documentation practice and audit readiness
Industry players and sector-specific jargon and abbreviations (URS, ICH, P&ID, GXP)
Opportunities within the healthcare sector

This programme is designed for organisations or individuals seeking to enter the pharmaceutical and medical device industries. It is particularly beneficial for:

Managers
Engineers
Technical Specialists
Quality Assurance personnel

The training is particularly beneficial for companies intending to supply into the healthcare industry or individuals applying for positions within regulated healthcare manufacturing. It equips learners with relevant knowledge and helps them leverage their existing skills to compete and succeed with the sector.

A good standard of written and spoken English is important to engage effectively with this programme.

On successful completion of this course, learners will be able to:

Explain the principles that govern pharmaceutical and medical device manufacturing.
Identify the key regulatory bodies and frameworks in Europe, the US, Canada, Asia and globally.
Apply knowledge of hygiene, sterility and cleanroom practices to healthcare manufacturing.
Describe the validation lifecycle for processes, computer systems, laboratory systems and cleaning.
Analyse the role of risk management and apply core techniques aligned with ISO 14971 and ICH Q9.
Recognise the importance of documentation, records and audit readiness.
Identify potential pathways within the pharmaceutical and medical device sectors.

These outcomes ensure that learners return with the practical skills and knowledge necessary to transition confidently into regulated healthcare industries.

This course is delivered by highly experienced tutors with specialist expertise in pharmaceutical and medical device manufacturing. Each Tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support.

Learners benefit from their combined knowledge, ensuring practical and applied learning throughout the programme.

Gerry Burke

Gerry is a self-motivated medical industry professional with kn...

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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Our methodology emphasises interactive and practical learning.

Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation.
Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance.
Live training is available virtually or delivered onsite to suit the needs of the team
Real-time support from expert tutors

Class sizes are generally limited to 12-15 participants to support personalised learning and individual support.

Learners who complete this course often continue to deepen their skills in:

Process Validation & Equipment Validation
21 CFR Part 11 Electronic Records and Electronic Signatures and Data Integrity
Medical Device Risk Management and ISO 14971:2019
ISO 134853
Technical Writing Skills

This progression ensures ongoing professional development within the healthcare manufacturing sector.

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Snapshot

Online Learning FAQ >

Course Code

LS006

Duration

2 training days

Delivery Mode

Available for In-House and delivered through Virtual Classroom Training

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