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Medical Device Manufacturing Preparation Course
Day. 1. Communications Skills and Working in a Team
Day 2. CV Preparation and Interview Skills
Day 3 – 6 Cleanroom course: as below.
Module 1: Overview of Medical Device Operations (Duration 0.2 days)
Content:
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Review Medical Device Industries in the West.
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Understand the products that they make and their uses.
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Actually see and feel the products they make.
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Get familiar with the different depts. within these industries.
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Look at employment opportunities in these sectors.
Learner Outcome: On completion of this module learners will understand what
types of products are made in these industries, know the importance of real life
uses of these products and become familiar with the roles and responsibilities of
different departments within these industries.
Module 2: Overview of Cleanroom Operator Work Practices & GMP (Duration 1.5
days)
Content:
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Understand what is a cleanroom
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Why we need cleanrooms to manufacture the products
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Understand what is contamination
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Understand what are the impacts if contamination enters the cleanroom
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Understand cleanroom policies and behaviours regarding personnel
working in the cleanroom
•
Understand the function of cleanroom garb
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Perform gowning up processes
•
Wear the cleanroom garb for a day to get the feel of what it’s like
•
Perform effective hand-washing exercises
•
Perform effective cleaning of bench surfaces and equipment
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Understand how to effectively transfer materials into the cleanroom
•
Understand why the cleanroom is monitored and the different types of
monitoring performed.
Learner Outcome: On completion of this module learners will have a better
understanding of the requirements and function of a cleanroom & heightened
awareness as to how they and the various cleanroom processes they perform, can
significantly contribute to contamination levels.
Module 3: Introduction to Basic Microbiology and how it impacts on cleanroom
technology & Microscopy Use (Duration 0.5 days)
Content:
•
Understand the different types of contamination that may be found in the
cleanroom and the criticality of the different types both in the environment and
on the product.
•
Observe some of the critical bacteria found in cleanrooms growing on a
plate.
•
Understand how to link personnel behaviours with these types of
bacteria.
•
Use of a microscope to view medical device products and bugs.
Learner Outcome: On completion of this module learners will understand the
types of contamination typically found in the cleanroom and its impacts on the
manufacturing environment and on product.
Module 4: Regulations and Standards. ISO 13485 and FDA Explained (Duration 0.4
days)
Content:
•
Understand the need for regulatory bodies
•
What are the regulatory bodies for medical device companies?
•
What is ISO?
•
What is ISO 13485? – Overview of its main requirements
•
Differences and similarities between ISO and FDA
•
Review sections from the FDA code of federal regulations to understand
the language.
Learner Outcomes: On completion of this module learners will understand why
medical device companies need to be strictly regulated, understand the main
terminology from the different standards and what their different requirements
are.
Module 5: Cleanroom operating procedures and documentation (Duration 0.25
days)
Content:
•
What is an SOP?
•
Purpose of an SOP
•
Anatomy of an SOP
•
Function of an SOP
•
Following an SOP correctly
•
Read and understand an SOP
•
Understand the change control process
•
How documentation /SOPs are controlled effectively.
Learner Outcome: On completion of this module learners will understand the
function of an SOP, have read an SOP, understand how to read and follow an SOP
correctly, understand how SOP’s are carefully controlled to ensure that all
personnel are working from the same revision.
Module 6: Importance of Documentation and completion of same – do’s and
don’ts of paperwork. (Duration 0.75 days)
Content:
•
Why do we require documentation?
•
Good Documentation Practices (GDP)
•
Completing a batch record using GDP
•
Reviewing documentation for errors.
Learner Outcome: On completion of this module learners will understand the GDP
requirements in the medical device industries and be competent to complete
documentation using GDP.
Module 7: Cleanroom equipment and machinery (Duration 0.2 days)
Content:
•
Overview of commonly used pieces of equipment found in cleanrooms
e.g. callipers, micrometer, thread gauges, shadowgraph etc.
•
Function of equipment calibration and calibration stickers.
Learner Outcome: On completion of this module learners will have an
understanding of the function of some of the common types of equipment used in
cleanrooms and understand the importance of equipment calibration.
Module 8: Safety in the workplace, accountability, duty of care (Duration 0.2 days)
Content:
•
Common accidents that occur in the workplace
•
Main causes of accidents in the workplace
•
Importance of reporting accidents in the workplace
•
Duties of the employee when working with regard to H&S
•
Importance of PPE
•
Understanding the function of a safety statement.
Learner Outcome: On completion of this module learners will understand their
responsibilities and duty of care with regard to H&S in the workplace. They will
also have knowledge of typical / common accidents that occur and what a safety
statement is.
TRAINING METHODOLOGY
This training programme is designed specifically for adult learners and in
particular, for job seekers so it will be very interactive, constantly encouraging
discussion and feedback from the participants to ensure their understanding. To
achieve this different training methods and styles will be applied to deliver the
key messages e.g. discussions, group activities, demonstrations and practical
exercises.
Individual learner feedback questionnaires will be completed at the end of the
course.
COURSE MANUAL
The course manual will contain a full set of course slides and accompanying notes,
which will prove to be an excellent source of reference after the course in
preparation for job interviews.
COURSE PRESENTER: Dr Kevina O’Donoghue
Dr. Kevina O’Donoghue, Microbiologist will be delivering the training for SQT.
Kevina O’Donoghue is a PhD graduate from the National University of Ireland,
Galway and has worked with cleanroom environments for nearly 10 years.
Beginning in the diagnostics sector, working for Cambridge Diagnostics, and then
moving to the medical device sector, working for Abbott Vascular Galway, she
worked as a Microbiologist and was closely involved in the setting up of new
cleanroom environments, validation of cleanroom environments, management of
the environmental monitoring programme, auditing of cleanrooms and their
processes, sterilisation validations and training in contamination control and GMP.
She was one of the co-founders of a cleanroom technology network and
facilitated it.
Kevina set up her own business Micro Matters Ltd in Jan 2012 and provides
specialist cleanroom advice to companies both nationally and internationally,
performing audits, investigational work and training through SQT.
Kevina is currently project managing the third FÁS Medical Device Industrial Skills
Training program in Galway for SQT which is a 16 week program (10 weeks
classroom based training & 6 weeks work placement) and has achieved an
employment rate with learners of >50%. Kevina also delivers a FÁS evening course
entitled ‘Introduction to the Pharmaceutical, BioPharmaceutical & Medical Device
Sectors in Ireland.
She accomplished a certificate in Training and Continuing Education, National
University of Ireland, Maynooth and completed the Certified Auditor / Lead
Auditor ISO 9001:2000 Quality Management System training in 2007.