This document provides an overview of training courses offered by QbD Academy in 2017 related to quality assurance in the pharmaceutical, medical device, and biotech industries. QbD Academy offers both on-site and online training courses on various topics including auditing, quality management systems, good manufacturing practices, validation, and regulations. The training courses range from half-day to multi-day sessions and cover the objectives, content, duration, and location for each course. Contact information is also provided for QbD Academy.

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Quality assurance
in the pharmaceutical
medical device & biotech industry
Overview Training 2017

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QbD Academy
At QbD, we like to pass our expertise on to our clients and partners. That’s why we offer
training and coaching for companies, small groups and individuals.
When you participate in a QbD in-company training, you’re assured that
• training is in line with your company and your individual training needs
• you’re flexible in terms of time and location
• you receive a tailor made offer based on your needs
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Location
• On Site / GoToTraining
Fee / participant
• To be negotiated depending on training needs
Travel Cost
• At expense
Duration
• To be disclosed depending on the training needs
Organisational proposal

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QbD Training Overview 2017
• Audit training
• Introduction in Registration
• Introduction in QMS
• Good Manufacturing Practices (GMP)
• Good Distribution Practices (GDP)
• Good Laboratorical Practices (GCP)
• Introduction in Validation Basics
• Acceptance Sampling
• Design of Experiment (DoE)
• Quality by Design (QbD)
• GAMP5
• Intro Serialisatie
• Tech Transfer
• ISO 13485 – Medical Device
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5. 5
• Why?
– Within the (bio-)pharmaceutical industry, the quality of
the manufactured products must be guaranteed at all
times. In the past, a number of rules or good practices
were developed in this regard, by both legal authorities
and the sector itself. Vigilance and continuous
improvement of processes as well as in the development
of drugs are required.
• For whom?
– This workshop is intended for anyone who has recently
started in the pharmaceutical industry and wishes to
learn more about the expectations placed on the goods
produced according to GMP. No prior knowledge is
required.
– All participants who attend the complete workshop
receive a certificate.
• Duration?
– 1 day training and workshop
• Program
– The concept of ‘quality’ within the pharmaceutical
industry
– Standards and norms
Pharmaceutical legislation
Inspections and authorities
Drug registration
– ICH GMP content, meaning and requirements
– Principles
– Division of ICH GMP guidelines
– Requirements placed on employees and resources
– Requirements placed on production and controls
Complaints and recalls
– Internal audits
– Other expectations
Good Manufacturing Practices

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• Why?
– The new European guidelines on Good Distribution
Practice (GDP) of 5 November 2013 set out the rules to
help the industry face the latest challenges, such as the
rise in counterfeit medicines. The adoption of this
regulation by all players involved in the storage and
distribution of medicines is increasingly monitored by
governments.
• For whom?
– The new European guidelines on Good Distribution
Practice (GDP) of 5 November 2013 set out the rules to
help the industry face the latest challenges, such as the
rise in counterfeit medicines. The adoption of this
regulation by all players involved in the storage and
distribution of medicines is increasingly monitored by
governments.
• Duration
– 1 day training with workshop and Q&A session
• Program
– Introduction in GDP
Why GDP?
What are the expectations from the government?
Who has to be compliant with these GDP guidelines?
– The EU GDP guidelinE
Principles
Quality systems
Personnel & training
Facilities & equipment
Documentation
Operations
Complaints and recalls
Internal audits
– Distribution of pharmaceutical products
Good Distribution Practices

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• Why?
– GLP tries to provide organisations with a quality
assurance system to ensure, among other things, that
the data generated in the laboratory are reliable and
traceable. This requires a specific modus operandi that
makes knowledge of GLP necessary for each employee.
The rules must be followed. They are discussed in this
training but it is also explained why they are set up in
this way.
• For whom?
– You work in a regulatory environment, or will shortly be
working in a quality laboratory that has to deal with GLP.
Note: the instructors have no experience of animal
testing and this aspect of GLP is not dealt with in the
course
• Duration?
– 1 day training
• Program
– Introduction
– Legislation
– GLP
Definitions
Organisation/staff: training, hygiene
Programme for quality control
Facilities in a laboratory environment
Equipment (possibly software-controlled) and material:
calibration, qualification/validation
Test and reference material
Analytical methods and validations (Pharmacopoeia):
materials and reagents, specifications and out of
specifications (OOS), change of control
Work instructions – SOP
Carrying out the research
Reporting and storage of data
Loss of qualification
Good Laboratorical Practices

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• Why?
– Validation is a way to prove that a system or process
works correctly, and complies with fixed acceptance
criteria. Each pharmaceutical or cosmetic product needs
a quality control process to guarantee that the products
meet quality requirements and comply with regulations.
A validation process results in a file with certifications
that prove to auditors that, by means of various tests,
you comply with the required criteria.
• For whom?
– This training is intended for people in the life sciences
(especially pharmaceuticals) or cosmetics sector with
little or no experience in validation and are planning to
get busy with validation.
• Duration
– 1 day training
• Program
– Learn the basic principles of and discuss the possibilities
for your validation process.
– Gain insight into the best start for your validation
process and required information and equipment.
– Learn the definition of validation related terms, like URS
certification, impact assessment or risk analysis.
– Discover how to design a validation test.
• In addition to this training, we offer a
Pharmaceutical Engineer training to extend your
knowledge to the technical aspects. We also
explore the subject and the issues we are facing in
the field in greater detail. This may lead to
internal or external assignments.
Introduction in Validation Basics

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• Why?
– Every company that makes products for the European or
American market is subject to the laws of the EMA
(European Medicine Agency), FDA (Food & Drug
Administration) and/or FAMHP (Federal Agency for
Medicines and Health Products). These include GMP
(Good Manufacturing Practices, also known as Predicate
Rules), 21CFR Part 11 and/or Annex 11.
• For whom?
– This training is intended for anyone involved in the
development/implementation of production systems for
the pharmaceutical sector, the cosmetics industry, the
food industry or related sectors where quality is an
important factor
• Duration?
– 2 day training
• Program
– Introduction
– ISPE
– Workflow of systems: V model
– Phasing
– Design and Validation
– Risk-Based Approach and ASTM E2500
– Commissioning & Qualification
– Tasks and responsibilities
– Maintenance of validated systems
– Risk Management
– What requirements are placed on staff?
– How to deal with suppliers and subcontractors?
– What tasks are expected in the various project phases?
System validation / Qualification

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• Why?
– GAMP is a practical interpretation of this legislation and
can be regarded as a structured and project-based
approach for the validation of (automation) systems. In
fact, this approach includes various working methods
that could generally be considered good practice.
• For whom?
– This training is intended for anyone involved in the
development/implementation of automated production
systems for the pharmaceutical sector, the cosmetics
industry, the food industry or related sectors where
quality is an important factor.
• Duration?
– 2 day training
• Program
– Introduction
FDA, EMA and regulations
ISPE
– GAMP 5
Workflow of automation systems: V model
Differences compared to GAMP 4
Phasing
Design and validation
– 21CFR Part 11
Electronic records
Electronic signatures
Audit trail
Practical interpretation
– Annex 11
Risk management
What requirements are placed on staff?
How to deal with suppliers and subcontractors?
What tasks are expected in the various project phases?
GAMP5

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• Why?
– After the training, participants will understand; the roles
and responsibilities of the sending unit, the receiving
unit and the project team, the various phases within a
Tech Transfer project, the main pitfalls and threats to
quality, the regulatory impact of the main types of
transfer.
– Afterwards, participants can independently; fulfil their
own role within the team, spot potential problems and
make proposals for improvements, estimate the
regulatory impact of changes.
• For Whom?
– Employees of small and large companies faced with
technology transfer,
– Project managers of technology transfer projects,
– The training focuses on technology transfer within the
pharmaceutical industry.
• Duration?
– 4-hour or 8-hour training.
• Program
– During the 8-hour training, a number of workshop
elements are provided that focus on the specific
situation of the course participant(s). While for the 4-
hour training, the focus is mainly on theory and
independently learning to find additional information.
Tech Transfer

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• Why?
– The aim of this training is to acquire an understanding of
the various audit processes and provide tips so that you
are in a position to both successfully carry out and
undergo an audit
• For whom?
– In particular, new QA operatives wanting to broaden
their base.
• Duration?
• 1 day training
• Program
– Theory
Quality systems
Standards relating to audits
Types of audit, the people involved and
SOPs
The general audit process
Auditor skills and climate
Discussion of different audits
- Exercises (tools)
- Test
Audit Training

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• Why?
– Falsified medicines are a serious threat to patients all
over the world. More and more governments are
therefore enacting new legal requirements to enforce
anti-counterfeiting measures in the supply chain. This
legislation poses a big challenge in addition to significant
costs to organisations that manufacture, distribute and
sell drugs, as they seek to comply with the mandates.
• For whom?
– This training is intended for people involved in the
packaging of pharmaceuticals who are facing current and
upcoming legal requirements for serialisation and track
& trace.
• Duration?
– Half-day training and discussion
• Program
– Acquire a clearer picture of how to set up a serialisation
system.
– Get an overview of the current and upcoming legal
requirements.
– View the risks involved with serialization.
– Discuss the best validation methods with your co-
participants.
– In addition, we pay much attention to change
management.
Serialization

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Intro in Sterilization Validation
• Why?
– For the safety of end users, it is important that
sterilization processes are validated. Such validation
entails detailed measuring of various physical
parameters throughout the sterilization process and
assessing and comparing these results to relevant
international standards.
• For whom?
– This workshop is intended for anyone involved in
pharmaceutical sterilization
• Duration?
– Half-day training and discussion
• Program
– Why Sterilization?
– Sterilization methods
– How to: Sterilization Validation

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• Why?
– The quality of an inspection lot is often evaluated by
means of a sample survey during an IPC or – in case of
doubt – by re-examination. The inspection lot is
compared to predefined specifications or requirements.
This enables a quality inspector or auditor to decide
whether to accept or reject certain products. Acceptance
sampling – a statistical technique based on the ISO
regulations 2858 and 3951 – is an important part of
quality control and an accurate method to guarantee
quality of products without enormous testing costs.
• For whom?
– Quality employees working in the pharmaceutical sector,
the cosmetics industry, the food industry or related
sectors. People responsible for creating purchasing
specifications and related defect tolerances.
• Duration
– Half-day training
• Program
– Introduction
– Applying ISO 2859 part 1
AQL vs. UQL
Sampling plans
Operating Characteristic Curves
Exercises
– Mistakes about acceptance sampling
– Acceptance Sampling individual batches (ISO 2859 part
2)
– Acceptance Sampling – variables
Introduction in Acceptance Sampling

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• Why?
– For organizations in the life sciences (pharmaceuticals,
medical devices, …) or food industry, experiments and
tests are regular processes. They usually occur as part of
a root cause research or during the development or
improvement of a process. The outcome of such a
process is often determined by various verifiable or
unverifiable parameters. A Design of Experiments (DoE),
or in other words statistical test design, offers insight
into the effects of these parameters and their mutual
interactions.
• For whom?
– Employees planning to set up and analyse experiments
within an organisation, production, research or
laboratory, and supporters of SPC wanting to improve
the suitability of their processes.
• Duration?
– Half-day training
• Program
– Get to know the basics of DoE in a unique, simple and
informative way.
– Discover possible analytical tools and explore them using
various examples and assignments.
– Participants learn to make full use of systematic quality
care.
Design of Experiment (DoE)

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• Why?
– Within the (bio-)pharmaceutical industry, the quality of
the products being manufactured must be guaranteed at
all times. In the previous era, the agencies were focused
on end quality product testing. The view of quality gurus
in the 20th century: “Quality cannot be tested into a
product, it must be there in the first place” is how quality
is currently being treated by the agencies.
Specific knowledge is required to introduce the concept
to management and the project engineers that perform
this new quality approach.
• For whom?
– This workshop is intended for anyone who has struggled
with the guidelines and wants to understand how it can
be applied. No prior knowledge is required, but an
understanding of a product lifecycle is a plus (tech
transfer → commercial manufacturing → termination).
All participants who attend the complete workshop
receive a certificate.
• Duration?
– Half-day training and discussion
• Programme
– Overview of the background in which QbD is set
– Introduction to broader quality concepts
– Why QbD
– ICH 8, 9 & 10 (Pharmaceutical Development, Quality Risk
Management & Pharmaceutical Quality System)
– Principles
Criticality
Design space
Control strategy
– Risk assessment drill down (methods on how to turn
QbD into practice)
– FDA process validation guidance 2011
Revisit the guidance with QbD in mind
Quality by Design

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CCIT testing and component qualification
• Why?
– Just like the pharmaceutical product, primary packaging
materials are subject to certain rules and standards (USP,
EP and JP Pharmacopoeia, ISO standards,…). Container
closure integrity testing (CCIT) is required from the
government. Therefore, this test will also be subject of
this training.
• For whom?
– This workshop is intended for anyone involved in CCIT
testing and component qualification
• Duration?
– Half-day training and discussion
• Program
– What: Primary Component?
– How: Component Qualification?
– QbD concept (cfr separate training)- Component
Qualification
– CCIT: (technical) issues

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• Why?
– This standard is a Quality Management System that is
specifically applicable on the production of medical
devices and their suppliers. ISO13485 clarifies what
needs to be done to comply with legislative and client
demands.
– More specifically this standard and logically this training
focus on the research and development phase,
production, warehousing and transportation,
installation, customer service and the elimination of the
medical device.
• For whom?
– This course explains the latest version and assures the
organization understands which steps need to be taken
to reach ISO13485 compliancy.
• Duration
– 1 day training
• Program
– Quality Management System
– Personel
– Product execution
– Monitor, measure, analyse and remediate
– Manage change
– Risk Management
ISO 13485: Medical Devices

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Contact
info@QbD.eu
Belgium
Fotografielaan 18
2160 Wilrijk
The Netherlands
Pivot Park
Molenweg 55
5349 AC Oss
Spain
C/ Aragón 390-394
6ª Planta
08013 Barcelona
Mexico
Culiacán 114A int. 202,
Del. Cuauhtémoc 06100
Ciudad de México