QUALITY MANAGEMENT AND GLP
SUMMARY
MASTER BIOMEDICAL SCIENCES – INFECTIOUS AND TROPICAL
DISEASES
, INTRODUCTION
LEARNING OUTCOMES
- The student has gained insight in the different parts of the quality management systems and
understands the link between each of these
- The student knows the basic principles of good manufacturing practices and can apply these
on different practical cases
- The student is able to understand and explain the different requirements for a quality
management system specific for production sites of medical devices and suppliers and is able
to create a pathway for a medical device to enter the commercial market
- The student understands the different aspects, rules, responsibilities, and interactions which
exist in the clinical research field and is able to apply these aspects on different practical cases
- The student is able to explain the need of good laboratory practices (GLP) and how they are
implemented in non-clinical research laboratories
- The student is able to explain the organization and follow-up of GLP at national and
international level
- The student is able to explain what GLP compliance is and how this is evaluated
EXAM
- 25%: practical assignments in groups
o The students show that they can analyze a clinical study protocol, can report
discovered issues and can suggest potential action plans
o The students show that they can classify medical devices and can draw up a plan to
take a medical device to the market
o You need at least 10/20 to obtain a credit
- 75%: written exam
o The students show they understand the different parts of the quality management
systems and understand the link between each of these
o The student show they know the different requirements for a quality management
system specific for production sites of medical devices and supplier
o The student show they understands the different aspects, rules, responsibilities, and
interactions which exist in the clinical research field
o The student show they know the need of good laboratory practices (GLP) and how
they are implemented in non-clinical research laboratories
o The student show they understand the organization and follow-up of GLP at national
and international level
o The student show they know what GLP compliance is and how this is evaluated
1
, TABLE OF CONTENTS
Lecture 1: Intro to Quality Management System (QMS) (p3 – p15)
Lecture 2: Good Laboratory Practices (p16 – p36)
Lecture 3: Good Laboratory Practices, Compliance and Quality Assurance (p37 – p45)
Lecture 4: Clinical research, ICH GCP and ISO 14155, An Introduction (p46 – p58)
Lecture 5/6/7: The Informed Consent Process, Documentation,Quality Control and Protocol
Compliance in Clinical Trials (p 59 – p118)
Lecture 8: Medical Device – roadmap to CE marking (p119 – p134)
Lecture 9: ISO 13485: Medical devices – Quality management systems (p135 – p153)
Lecture 10/11: Introduction to Good Manufacturing Practices (GMP) (p154 – p170)
Exercises: p171 - p
2
, INTRO TO QUALITY MANAGEMENT SYSTEM (QMS)
THE CONCEPTS OF QUALITY, QUALITY MANAGEMENT AND QMS
This is very dependent who you ask and about what, so it is very subjective.
WHAT IS QUALITY?
- Sustainable is more and more important these days
- Compliant: in line with the regulatory requirements (for
example European or Belgian)
- The term “Quality” in industry? (There are different definitions in industry):
o “Fitness for purpose”
o “Meeting specifications”
o “Conformity to requirements”
o “The right product at the right time at the right price”
o “Getting it right the first time, every time”
o “Making goods which do not come back…for customers who do”
o Making goods that are not breaking do, so what the customer wants (customer
satisfaction and reliability are very important)
- Quality of what?
o Product
o Service
o Business performance
o Environmental impact
The cost of (bad) quality
There is a cost to quality, mainly to bad quality. How can bad quality be costly for a company: you
have invested a lot, but at the end it didn’t work / it can give you a bad name as a company.
- Monetary costs: replacements, compensation, repairs, destruction/loss
- Process costs: investigating why the product broke down for example, retesting, remaking
- Loss of time: down time, disagreements with (internal/external) customers
o People need to investigate and can’t do other things in that time
- Image: complaints, recall, claims, law suits, bad media coverage
o Some products needed to be recalled, the company stays in your memory
- And of course you might lose unhappy customers to competitors
o But satisfy an unhappy customer by helping them appropriately…and they are more
likely to return (= service recovery paradox)
▪ Service recovery paradox: bol.com for example is very known for the fact that
when you sent a complain, they don’t even ask something, they just sent a new
one
Quality
- Applies to both products and services
- Is measurable
- Has to be tailored to the customer’s needs
3
SUMMARY
MASTER BIOMEDICAL SCIENCES – INFECTIOUS AND TROPICAL
DISEASES
, INTRODUCTION
LEARNING OUTCOMES
- The student has gained insight in the different parts of the quality management systems and
understands the link between each of these
- The student knows the basic principles of good manufacturing practices and can apply these
on different practical cases
- The student is able to understand and explain the different requirements for a quality
management system specific for production sites of medical devices and suppliers and is able
to create a pathway for a medical device to enter the commercial market
- The student understands the different aspects, rules, responsibilities, and interactions which
exist in the clinical research field and is able to apply these aspects on different practical cases
- The student is able to explain the need of good laboratory practices (GLP) and how they are
implemented in non-clinical research laboratories
- The student is able to explain the organization and follow-up of GLP at national and
international level
- The student is able to explain what GLP compliance is and how this is evaluated
EXAM
- 25%: practical assignments in groups
o The students show that they can analyze a clinical study protocol, can report
discovered issues and can suggest potential action plans
o The students show that they can classify medical devices and can draw up a plan to
take a medical device to the market
o You need at least 10/20 to obtain a credit
- 75%: written exam
o The students show they understand the different parts of the quality management
systems and understand the link between each of these
o The student show they know the different requirements for a quality management
system specific for production sites of medical devices and supplier
o The student show they understands the different aspects, rules, responsibilities, and
interactions which exist in the clinical research field
o The student show they know the need of good laboratory practices (GLP) and how
they are implemented in non-clinical research laboratories
o The student show they understand the organization and follow-up of GLP at national
and international level
o The student show they know what GLP compliance is and how this is evaluated
1
, TABLE OF CONTENTS
Lecture 1: Intro to Quality Management System (QMS) (p3 – p15)
Lecture 2: Good Laboratory Practices (p16 – p36)
Lecture 3: Good Laboratory Practices, Compliance and Quality Assurance (p37 – p45)
Lecture 4: Clinical research, ICH GCP and ISO 14155, An Introduction (p46 – p58)
Lecture 5/6/7: The Informed Consent Process, Documentation,Quality Control and Protocol
Compliance in Clinical Trials (p 59 – p118)
Lecture 8: Medical Device – roadmap to CE marking (p119 – p134)
Lecture 9: ISO 13485: Medical devices – Quality management systems (p135 – p153)
Lecture 10/11: Introduction to Good Manufacturing Practices (GMP) (p154 – p170)
Exercises: p171 - p
2
, INTRO TO QUALITY MANAGEMENT SYSTEM (QMS)
THE CONCEPTS OF QUALITY, QUALITY MANAGEMENT AND QMS
This is very dependent who you ask and about what, so it is very subjective.
WHAT IS QUALITY?
- Sustainable is more and more important these days
- Compliant: in line with the regulatory requirements (for
example European or Belgian)
- The term “Quality” in industry? (There are different definitions in industry):
o “Fitness for purpose”
o “Meeting specifications”
o “Conformity to requirements”
o “The right product at the right time at the right price”
o “Getting it right the first time, every time”
o “Making goods which do not come back…for customers who do”
o Making goods that are not breaking do, so what the customer wants (customer
satisfaction and reliability are very important)
- Quality of what?
o Product
o Service
o Business performance
o Environmental impact
The cost of (bad) quality
There is a cost to quality, mainly to bad quality. How can bad quality be costly for a company: you
have invested a lot, but at the end it didn’t work / it can give you a bad name as a company.
- Monetary costs: replacements, compensation, repairs, destruction/loss
- Process costs: investigating why the product broke down for example, retesting, remaking
- Loss of time: down time, disagreements with (internal/external) customers
o People need to investigate and can’t do other things in that time
- Image: complaints, recall, claims, law suits, bad media coverage
o Some products needed to be recalled, the company stays in your memory
- And of course you might lose unhappy customers to competitors
o But satisfy an unhappy customer by helping them appropriately…and they are more
likely to return (= service recovery paradox)
▪ Service recovery paradox: bol.com for example is very known for the fact that
when you sent a complain, they don’t even ask something, they just sent a new
one
Quality
- Applies to both products and services
- Is measurable
- Has to be tailored to the customer’s needs
3
