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Quality assurancein 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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• 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

DefinitionsOrganisation/staff: training, hygieneProgramme for quality controlFacilities in a laboratory environmentEquipment (possibly software-controlled)

and material: calibration, qualification/validationTest and reference materialAnalytical methods and validations

(Pharmacopoeia): materials and reagents, specifications and out of specifications (OOS), change of control

Work instructions – SOPCarrying out the researchReporting and storage of dataLoss 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

– IntroductionFDA, EMA and regulationsISPE

– GAMP 5Workflow of automation systems: V modelDifferences compared to GAMP 4PhasingDesign and validation

– 21CFR Part 11Electronic recordsElectronic signaturesAudit trailPractical interpretation

– Annex 11Risk managementWhat 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 systemsStandards relating to auditsTypes of audit, the people involved and SOPsThe general audit processAuditor skills and climateDiscussion 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

BelgiumFotografielaan 182160 Wilrijk

The NetherlandsPivot ParkMolenweg 555349 AC Oss

SpainC/ Aragón 390-394 6ª Planta08013 Barcelona

MexicoCuliacán 114A int. 202, Del. Cuauhtémoc 06100Ciudad de México