Quality by Design Training in Turkey

Build Quality in from Day One

Built for pharmaceutical and biopharma professionals across Turkey, this instructor-led programme shows you how to engineer quality into products from the design stage using the ICH Q8(R2) framework, the Quality Target Product Profile, critical quality attributes, Design of Experiments and a robust control strategy.

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Master Quality by Design and Lead Excellence in Turkey

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What Is Quality by Design and Why Pharma Teams Rely on ItA Science-Based Path to Product Quality

Quality by Design Training in Turkey introduces Quality by Design (QbD), a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It is the way modern development and quality teams work, and it is increasingly expected by regulators.

Grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH Q9, Q10 and Q11 quality framework, the programme teaches you to define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run risk assessments, apply Design of Experiments (DoE), establish a design space and build a control strategy that keeps production consistently on target.

As Turkey's pharmaceutical sector expands and the Turkish Medicines and Medical Devices Agency (TITCK) moves closer to full ICH membership, employers increasingly want formulation, process, analytical and quality teams who can work the QbD way. The course suits pharmaceutical scientists, process engineers, QA and regulatory affairs professionals who want practical, job-ready skills. Start your QbD journey with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Turkey is designed to help learners understand QbD principles, regulatory frameworks, and pharmaceutical product development methodologies covered in the program
Course content aligned with current ICH Q8, Q9, and Q10 guideline expectations, real-world pharmaceutical quality requirements, and practical learning objectives for Turkey professionals delivered through a comprehensive Quality by Design training program
Real-world examples and scenario-based learning to help learners connect QbD concepts with everyday pharmaceutical development, manufacturing, and quality assurance situations
Guided learning support to help participants strengthen understanding, improve confidence, and apply QbD principles effectively across product development and manufacturing roles

Structured Courseware and Learning Resources

Access to organized QbD course materials including QTPP definition worksheets, CQA and CMA identification templates, CPP mapping guides, and DoE reference cards designed to support step-by-step learning
Topic-wise learning resources, exercises, and knowledge checks to reinforce understanding of Design Space, control strategies, and risk assessment tools
Practice activities, assignments, and scenario-based exercises to help learners apply QbD concepts in realistic pharmaceutical product development and manufacturing quality situations
Supplementary learning aids such as risk assessment matrices, Design Space configuration worksheets, RTRT implementation checklists, and control strategy development guides

Instructor-Led, Practical Learning Experience

Live interactive sessions delivered by experienced QbD practitioners with hands-on domain expertise across pharmaceutical, biotechnology, and manufacturing sectors
Real-world examples, case discussions, and applied QbD exercises to improve practical understanding of QTPP definition, CQA identification, DoE applications, and Design Space configuration
Opportunities to ask questions, clarify doubts, and participate in trainer-led discussions on risk assessment, CPP mapping, and regulatory compliance requirements
Training approach focused on helping learners apply QbD concepts confidently at work, not just complete the course content

Flexible Learning Support in Turkey

Instructor-led training formats available for individual learners and corporate teams across the Turkey
Options include live virtual classroom training, onsite training, and customized group training depending on availability and organizational requirements
Learning support designed to help participants stay on track before, during, and after the Quality by Design training
Additional revision and post-training support may be available based on the selected course format

Learn the Core Concepts Covered in the Course

Understand QbD fundamentals, background, key drivers, and the regulatory guidance documents including ICH Q8, Q9, and Q10 that shape modern pharmaceutical development
Learn how to define QTPP, identify CQAs, CMAs, and CPPs, apply DoE, configure Design Space, and develop control strategies based on the course curriculum
Explore practical use cases showing how QbD is applied in pharmaceutical, biotechnology, healthcare, and manufacturing environments
Build role-relevant knowledge of risk assessment and management, real-time release testing, and regulatory compliance that supports better quality decisions in product development

Practice, Assessment, and Completion Support

Practice defining QTPP, identifying CQAs and CMAs, mapping CPPs, and applying DoE through exercises and scenario-based activities
Use assessments to identify knowledge gaps in QbD concepts and strengthen understanding of Design Space and control strategy development
Receive guidance from instructors to improve understanding of QbD tools and stay aligned with course objectives
Earn a course completion certificate after successfully meeting the training requirements

Career and Workplace Application

Build practical QbD skills that can support career growth, role advancement, or improved pharmaceutical quality performance in the Turkey
Strengthen confidence in applying QTPP definition, CQA identification, DoE, Design Space, and risk management concepts to real-world product development challenges
Improve professional credibility through structured, skill-focused Quality by Design training recognized across Turkey pharmaceutical and manufacturing industries
Support enterprise capability building through Quality by Design corporate training for employees across pharmaceutical, biotechnology, healthcare, and manufacturing organizations.

Quality by Design Training Eligibility in the TurkeyWho Can Enroll?

No formal prerequisites are required to enroll in the Quality by Design training program
Basic familiarity with quality assurance concepts is helpful but not mandatory for enrollment
Professionals from pharmaceutical, biotechnology, healthcare, and manufacturing industries are well-suited for this training
Individuals and corporate teams seeking to build QbD knowledge and apply regulatory-aligned product development principles are eligible to enroll
Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

What You Gain from Mastering Quality by DesignSkills You Apply from the Next Project

For Individuals

Quality by Design training helps pharmaceutical professionals move from reactive, test-and-fix development to a proactive, science-based way of working. You learn to understand how material attributes and process parameters shape product quality, then control them by design. Whether you develop small molecules, biologics or work in QA and regulatory affairs, the course builds capabilities you can apply on live product development projects straight away.

If you want to lead QbD thinking in your organisation, this programme gives you a clear, practical toolkit. You gain the QTPP, CQA, risk assessment, DoE and control strategy skills that pharmaceutical employers across Turkey increasingly value.

Design quality into products from the start instead of testing it in at the end
Apply the ICH Q8 to Q11 toolkit that regulators and employers now expect
Build QTPPs, identify CQAs and link them to material and process parameters
Run risk assessments with FMEA and Ishikawa to focus development effort
Use Design of Experiments to define and defend a design space
Develop a control strategy and structure QbD evidence for CTD submissions
Stand out for formulation, process, analytical and quality roles in Turkey

For Organizations

Quality by Design group training equips cross-functional development and quality teams to build robust processes and defensible regulatory dossiers. It is ideal for pharmaceutical and biopharma organisations investing in local development and manufacturing capability. When a whole team learns QbD together, they can apply the tools directly to current projects, aligning formulation, process, analytical and regulatory work around one approach.

For organisations facing cost pressure, localisation targets and rising regulatory expectations, QbD capability is a practical advantage. Teams learn to reduce variability, cut waste and connect development decisions to consistent, compliant product quality.

Fewer manufacturing deviations, rejections and out-of-specification batches
Stronger, science-based development that speaks the language of regulators
A shared QbD vocabulary across formulation, process, analytical and QA teams
Design space flexibility that reduces the post-approval change burden
Faster, more confident CTD submissions to TITCK and other authorities
Consistent product quality that protects patients and brand reputation
Team training tailored to your own products and development pipeline

Where Quality by Design Skills Take Your Career in TurkeyRoles, Demand and Earning Potential

Quality by Design skills open doors across Turkey's expanding pharmaceutical sector, from formulation and process development to analytical science, QA and regulatory affairs. As TITCK aligns with ICH standards, local API and biosimilar production grows, and manufacturers face pressure to cut waste, employers increasingly seek professionals who can build quality into products by design. Demand spans small molecule and biologic development, and here is what the market is telling us right now.

$22.3bn

Turkey pharma market size

2025, projected $32.6bn by 2034

85,000

Direct pharma sector jobs, Turkey

2023, up 5% year on year

103

Pharma manufacturing sites, Turkey

operating facilities, 2023

TRY 94,605

Quality Management Specialist pay

average monthly, Turkey Jan 2026

Sectors Hiring

—Pharmaceutical Manufacturing and Development
—Biopharmaceuticals and Biosimilars
—Active Pharmaceutical Ingredient (API) Production
—Contract Development and Manufacturing (CDMO)
—Regulatory Affairs and CMC Consulting
—Medical Devices and Generics

Market Growth Drivers

—TITCK advancing toward full ICH membership and QbD expectations
—Local API production rising, now around 35% of domestic demand
—Government backing for the domestic biosimilar and biotech sector
—Strong export base into European and Middle Eastern markets
—Cost pressure pushing manufacturers to cut deviations and rework
—Growing demand for scientists who can design quality in, not test it in

Sources: IMARC, Expert Market Research and Statista (Turkey pharma market 2025-2026); Invest Turkey and IEIS (manufacturing and API); Kariyer.net and Eleman.net (Turkey salaries 2026).

Designation

Quality by Design Professionals in Turkey : Salary Insights and Trends

Hiring Companies in Turkey

₺480K

Min

₺660K

Average

₺960K

Max

Kariyer.net · Eleman.net (Turkey) 2026

Abdi IbrahimDeva HoldingBilim IlacSanovel

Source: Abdi Ibrahim · Deva Holding · Bilim Ilac · Sanovel

Market Forces Making QbD Skills Essential in Turkey

Rising Regulatory Expectations

Turkey mandates CTD dossiers and TITCK is advancing toward full ICH membership, so regulators increasingly expect QbD evidence such as design space and control strategy in development submissions.

QbD builds ICH-aligned development skills

Scaling Local Manufacturing

With over 100 manufacturing sites and a national localisation push, more development teams must design robust processes up front rather than rely on end-product testing to catch problems.

QbD builds robust process understanding

API Localisation Drive

Local API production has climbed to around 35% of domestic demand. New drug-substance and process work needs the ICH Q11 QbD thinking that links critical parameters to product quality.

QbD builds process characterisation skills

Biosimilar and Biotech Growth

Turkey is actively backing its biosimilar sector. Complex biologics demand disciplined CQA identification, risk assessment and design space thinking to control molecular quality attributes.

QbD builds CQA and design space skills

Cost and Quality Pressure

Demand for affordable medicines pushes manufacturers to reduce deviations, rejections and rework. QbD delivers the process understanding that keeps quality consistent and costs down.

QbD builds variability-reduction skills

Export Market Requirements

Turkish exporters selling into European and Middle Eastern markets must meet FDA and EMA QbD expectations, making design-led development a competitive necessity, not an option.

QbD builds submission-ready capability

Sources: TITCK and PharmaRegulatory (ICH and CTD); Invest Turkey and IEIS (manufacturing, API, biosimilars) 2025-2026.

Quality by Design is more than a framework. It is a practical way to build better products and stronger dossiers. Join the professionals designing quality into pharma across Turkey. Start your QbD journey today.

Your Turkey Career Transformation

From Testing Quality in to Designing It In

The Shift QbD Makes to Your Work

Turkey's pharmaceutical sector is expanding through localisation, biosimilars and rising regulatory expectations, and employers increasingly separate teams who can design quality in from those who only test it. Here is which side of that line you want to be on.

Today

Limited to reacting to out-of-specification results after the fact

After QbD training

Able to predict and control quality across the whole process

Today

Limited to reacting to out-of-specification results after the fact

Today

Overlooked for senior development and quality roles that expect QbD

After QbD training

Ready for formulation, process, analytical and QA roles across Turkey's pharma sector

Today

Overlooked for senior development and quality roles that expect QbD

Today

Submissions built on fixed parameters and heavy end-product testing

After QbD training

Confident structuring QbD evidence for CTD dossiers under TITCK and ICH expectations

Today

Submissions built on fixed parameters and heavy end-product testing

You master QbD

Before

Quality checked by end-product testing, with deviations surfacing late

Now you have

A design-led approach that builds quality in from the start

Before

Quality checked by end-product testing, with deviations surfacing late

Before

Development run on trial and error and one-factor-at-a-time testing

Now you have

DoE-driven process understanding and a defined, defensible design space

Before

Development run on trial and error and one-factor-at-a-time testing

Before

Risk judged informally, case by case, with no clear prioritisation

Now you have

Structured FMEA and Ishikawa risk assessment linking CMAs and CPPs to CQAs

Before

Risk judged informally, case by case, with no clear prioritisation

Before

QbD sitting outside your day-to-day development toolkit

Now you have

A working command of the ICH Q8 to Q11 toolkit employers expect

Before

QbD sitting outside your day-to-day development toolkit

"The gap between testing quality in and designing it in is what separates modern pharma teams, and the employers that matter already know it."

Join the professionals who trained with Invensis Learning and made the shift to QbD.

Sources: Kariyer.net, Eleman.net, Paylab and SalaryExpert (Turkey) 2026.

Module 1: Introduction to QbD

Background and key drivers that led to the adoption of Quality by Design in pharmaceutical development
Regulatory guidance documents including ICH Q8, Q9, and Q10 that define the QbD framework
QbD development process flow from concept and design through to manufacturing and regulatory submission

Module 2: QbD Tools and Techniques

Risk management principles and tools used to identify, assess, and control quality risks in product development
Design of Experiments (DoE): fundamentals, design types, and how DoE is used to understand process variability
Design Space definition and control strategies: how boundaries are established and maintained throughout the product lifecycle

Module 3: Industry and Regulatory Perspective

Regulatory framework for QbD including agency expectations from the FDA, EMA, and ICH guidelines
Implementation challenges organizations face when transitioning from traditional to QbD-based development approaches
Real-world industry examples demonstrating how pharmaceutical and biotechnology organizations have adopted QbD

Module 4: Quality Target Product Profile (QTPP)

Definition of the Quality Target Product Profile and its role in guiding QbD-based product development decisions
How QTPP links patient needs and regulatory requirements to specific product quality attributes and design objectives
Practical steps for defining a QTPP for pharmaceutical and biotechnology products

Module 5: Critical Quality Attributes, Critical Material Attributes, and Critical Process Parameters

Identifying Critical Quality Attributes (CQAs): what they are, how to define them, and why they are central to QbD
Critical Material Attributes (CMAs): how raw material properties influence product quality and must be controlled
Critical Process Parameters (CPPs): identifying process parameters that impact CQAs and require monitoring and control

Module 6: Statistical Design of Experiments

Fundamentals of statistical DoE including full factorial, fractional factorial, and response surface methodologies
Applications of DoE in pharmaceutical process development and optimization
Interpreting DoE results to establish design space boundaries and process understanding

Module 7: Design Space and Process Control

Design Space concept: defining the multidimensional combination of input variables and process parameters that provide quality assurance
Implementation of Design Space within regulatory submissions and manufacturing control strategies
Continuous process verification and how Design Space supports process control across the product lifecycle

Module 8: Risk Assessment and Management

Risk assessment methodologies used in QbD including FMEA, Ishikawa diagrams, and risk ranking tools
Applying risk management principles to product development decisions, process design, and control strategy development
Linking risk assessment outcomes to Design Space boundaries and CQA control strategies

Module 9: Real-time Release Testing (RTRT)

RTRT concept: replacing end-product testing with in-process monitoring and real-time quality assurance
Regulatory requirements and industry expectations for RTRT implementation in pharmaceutical manufacturing
Practical considerations for implementing RTRT as part of a QbD-based control strategy

Module 10: Case Studies and Practical Applications

Pharmaceutical and biotechnology case studies demonstrating end-to-end QbD implementation from QTPP to RTRT
Practical group exercises and scenario analysis applying QbD tools including QTPP definition, CQA identification, DoE, and risk assessment
Lessons learned and best practices from real QbD projects in pharmaceutical, biotechnology, and manufacturing environments

Course Curriculumof the Quality by Design Training

The online Quality by Design training course curriculum in the Turkey is structured across ten modules, taking learners from foundational QbD background and regulatory guidance through to real-world case studies and practical applications in pharmaceutical, biotechnology, and manufacturing environments.

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Background and key drivers that led to the adoption of Quality by Design in pharmaceutical development
Regulatory guidance documents including ICH Q8, Q9, and Q10 that define the QbD framework
QbD development process flow from concept and design through to manufacturing and regulatory submission

Shifts your thinking from testing quality in at the end to designing it in from the start.

Module 1: Introduction to QbD

Background and key drivers that led to the adoption of Quality by Design in pharmaceutical development
Regulatory guidance documents including ICH Q8, Q9, and Q10 that define the QbD framework
QbD development process flow from concept and design through to manufacturing and regulatory submission

Shifts your thinking from testing quality in at the end to designing it in from the start.

100% Secure and Safe download

The QbD Capabilities You Will BuildTools You Will Apply on Real Projects

Here is what you will learn in Quality by Design training: a complete, practical toolkit for building quality into pharmaceutical products. By the end of the programme you can construct a QTPP, identify CQAs, run risk assessments, design and interpret DoE studies, define a design space and develop a control strategy.

Define the Quality Target Product Profile

Build a QTPP from clinical and patient needs, setting the dosage form, route, strength, pharmacokinetic targets and quality standards that anchor the whole QbD programme.

Identify and Classify Critical Quality Attributes

Translate the QTPP into CQAs for small molecules and biologics, then link each to critical material attributes and process parameters using prior knowledge and structured mapping.

Run Risk Assessments with FMEA and Ishikawa

Apply Ishikawa diagrams and FMEA with Severity, Occurrence and Detectability scoring to prioritise the parameters that matter most and focus experimental effort where it counts.

Apply DoE to Build the Design Space

Use screening, response surface and mixture designs to quantify how parameters affect CQAs, then define the design space, normal operating ranges and proven acceptable ranges.

Deploy PAT and a Robust Control Strategy

Understand Process Analytical Technology tools and real-time release testing, and develop a control strategy that keeps material, process and product quality within the design space.

Structure QbD Evidence for CTD Submissions

Present QTPP, CQA, risk assessment, DoE and control strategy work in the CTD Module 3 format, and manage the QbD lifecycle and post-approval change under ICH Q12.

Who Should TakeQuality by Design Training in Turkey?

Process Engineers

QC Analysts

Engineering Teams

Technical Staff

Production Managers

Distribution Managers

Regulatory Affairs Specialists

Quality Assurance Professionals

Who Can Take This Certification Training

Quality by Design Training Modesfor Professionals and Teams

We offer flexible training formats designed to suit different learning preferences, schedules, and professional goals. Whether you prefer self-paced learning or a structured, corporate, instructor-led experience, choose the option that best supports your skill development journey with the best Quality by Design online training options.

Quality by Design Classroom Training

Instructor-led classroom sessions
Interactive discussions and group activities
Real-world examples and practical exercises
Structured learning with fixed schedules
Opportunities for peer networking and collaboration
Practice assessments and knowledge checks
Dedicated Q&A and concept clarification
Immediate trainer feedback and support

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Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

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Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

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Quality by Design Live Virtual Training

Live online instructor-led sessions
Interactive discussions and virtual activities
Expert guidance from experienced trainers
Practice assessments and revision support
Dedicated Q&A sessions for concept clarification
Fixed schedules for accountability and momentum
Small batch sizes for personalized attention
Access from any location with internet connectivity

TRY 18370

Attend fully interactive weekday Quality by Design training sessions from anywhere while benefiting from real-time instructor guidance and collaborative learning experiences.

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Best For: Professionals seeking the flexibility of online learning without compromising on live instructor interaction.

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Quality by Design Corporate Group Training

Customized training aligned to organizational goals
Flexible delivery: onsite, virtual, hybrid, or blended
Scheduling tailored to business availability
Role-based examples and industry-relevant discussions
Progress tracking and learner assessments where applicable
Dedicated coordination and administrative support
Consistent learning experiences across teams
Scalable delivery for local, regional, or global workforces

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Designed for organizations that want to build capabilities at scale, standardize knowledge, and support workforce development through customized team learning initiatives.

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Best For: Organizations looking to upskill employees, address capability gaps, and deliver consistent training across teams.

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Quality by Design Focused 1-to-1 Training

One-to-one instructor attention
Customized learning plans and objectives
Flexible scheduling based on availability
Personalized feedback and coaching
Additional focus on challenging topics
Targeted practice and revision support
Faster clarification of questions and concepts
Learning pace is adapted to individual needs

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Receive personalized instruction tailored to your goals, pace, and learning requirements through dedicated sessions from our trusted Quality by Design training company.

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Best For: Professionals seeking personalized guidance, accelerated learning, or focused support to achieve specific outcomes.

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Quality by Design Classroom Training

Instructor-led classroom sessions

Interactive discussions and group activities

Real-world examples and practical exercises

Structured learning with fixed schedules

Opportunities for peer networking and collaboration

Practice assessments and knowledge checks

Dedicated Q&A and concept clarification

Immediate trainer feedback and support

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Please Note:Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

Loading schedules…

Why Choose Invensis Learning for Quality by Design Training in TurkeyExpert-Led, Flexible and Trusted

Invensis Learning delivers structured, practical Quality by Design training for pharmaceutical professionals and teams who want job-ready QbD skills. Our programmes combine experienced trainers, hands-on tool exercises and flexible delivery, all aligned to the ICH quality guidelines that underpin modern development. Whether you enrol as an individual or arrange corporate training for a cross-functional team, you get a professional learning experience built around real-world application, clear explanation and measurable outcomes. As an ISO 9001:2015 and ISO 27001:2022 certified provider serving learners across more than 100 countries, we make QbD capability achievable for your organisation.

Experienced trainers with real pharmaceutical development and quality expertise
Practical, hands-on exercises on QTPP, CQA, risk assessment, DoE and design space
Flexible formats: live virtual instructor-led, classroom and corporate onsite
Content aligned to the ICH Q8(R2), Q9, Q10 and Q11 quality guidelines
Course completion certificate from Invensis Learning on finishing the programme
ISO 9001:2015 and ISO 27001:2022 certified training operations
Dedicated learner support before, during and after the training
Scalable delivery for individuals and teams across Turkey and worldwide

5000+

Accredited Trainers Globally

4.7/5

Rated by Learners Worldwide

500+

Corporate Clients

15+

Years of Training Excellence

ISO 9001:2015 Certified

ISO 27001:2022 Certified

Secure SSL Encryption

Leaders in Training industry for 12+ years

Over 5000 five star reviews

Level AA conformance, W3C WCAG 2.2

Quality by Design Training Locations in TurkeyAll our classroom training is now available online at your convenience

Quality by Design in Turkey

Hilton Istanbul Bosphorus, 50, Cumhuriyet Caddesi, Taşkışla, Harbiye Mahallesi, Şişli, Istanbul, Marmara Region, 34367, Türkiye

Quality by Design in Turkey

Swissotel The Bosphorus Istanbul, Turkey

Quality by Design in Turkey

Hilton Istanbul Bosphorus, 50, Cumhuriyet Caddesi, Taşkışla, Harbiye Mahallesi, Şişli, Istanbul, Marmara Region, 34367, Türkiye

Quality by Design in Turkey

Swissotel The Bosphorus Istanbul, Turkey

Corporate Quality by Design Training for Your TeamBuild QbD Capability Across Your Organisation

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Tailored to your own products, dosage forms and development pipeline
Flexible delivery through onsite, live virtual, hybrid or blended formats
Trainers with practical pharmaceutical development and quality experience
Cross-functional learning that aligns formulation, process, analytical and QA teams
Hands-on QbD exercises applied to your live product development scenarios
Dedicated coordination and learner support for group programmes
Scalable delivery for teams across Turkey and global sites

What Our Learners Say

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QbD Finally Made Practical

"The training finally made QbD practical for me. Building a QTPP, mapping CQAs and running an FMEA on a real formulation clicked in a way it never had from reading the ICH guidelines alone."

Elif Yilmaz

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Design Space Made Sense

"The DoE and design space sessions were the highlight. I now understand how to plan experiments that actually define an operating range, instead of testing one factor at a time."

Mehmet Demir

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Directly Useful for Submissions

"As a regulatory affairs professional, the module on structuring QbD evidence for CTD submissions was directly useful. I applied the control strategy approach to a dossier the following week."

Zeynep Kaya

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A Shared Language for Our Teams

"We trained our development and quality teams together and it gave everyone a shared QbD language. Deviations discussions are far more structured now, and our risk assessments are more consistent."

Canan Ozturk

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Tailored to Our Pipeline

"The onsite corporate session was tailored to our biosimilar pipeline. The trainer connected CQA identification and control strategy to our actual products, which made the learning stick across the group."

Burak Sahin

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4.6

Ratings

100K+

Happy Learners

100+

Locations Worldwide

99%

Training Satisfaction

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Frequently Asked QuestionsHere's everything you may ask...

Quality by Design training teaches a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It covers the QTPP, critical quality attributes, risk assessment, Design of Experiments, design space and control strategy, grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines.

General

What is Quality by Design (QbD) training?

Is Quality by Design training worth it for my career in Turkey?

Yes. As TITCK aligns with ICH standards and Turkey grows its local API, generic and biosimilar production, employers increasingly want scientists who can design quality in. QbD skills support formulation, process, analytical, QA and regulatory roles across the sector, where quality management specialists average around TRY 94,605 per month in 2026.

Which standards and guidelines does the course follow?

The programme is grounded in the ICH Q8(R2) Pharmaceutical Development guideline, together with ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. It also references FDA and EMA expectations and the CTD submission format that TITCK requires.

Who should attend this Quality by Design programme?

It suits formulation scientists, process development engineers, analytical scientists, QA professionals, regulatory affairs and CMC specialists, and manufacturing technical managers in pharmaceutical, biopharma, API, CDMO and medical device organisations who want to understand and apply QbD.

Do I need prior QbD knowledge to join?

No. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, as the course introduces QbD from first principles in a practical development context.

Pricing

How much does Quality by Design training cost in Turkey?

Fees depend on the delivery format, whether you enrol as an individual or a group, and the schedule. Instructor-led and corporate options are priced separately. For current pricing in your preferred format, request a quote and a learning advisor will help.

What is included in the course fee?

The fee typically includes instructor-led training across all QbD modules, hands-on tool exercises, learning materials and case study examples, and a course completion certificate from Invensis Learning. Ask a learning advisor about the inclusions for each format.

Do you offer group or corporate pricing?

Yes. We offer corporate group training with tailored content and volume-based pricing for development and quality teams. It is ideal for organisations training a cross-functional group together. Contact us for a group quote for your team.

In what currency is the training billed?

Pricing can be arranged to suit learners and organisations in Turkey. Talk to a learning advisor for a quote in your preferred currency and delivery format.

Are there payment or instalment options?

Flexible payment options are available on selected plans. Speak with a learning advisor to choose the approach that best suits you or your organisation.

Assessment

Is there an exam for this course?

No. This is a practical skills programme with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case study examples and discussion throughout the training.

Do I receive a certificate after the training?

Yes. You receive a course completion certificate from Invensis Learning once you finish the programme. This is a skills training course, so there is no external awarding body or separate credential.

How are my skills assessed during the course?

There is no formal assessment. Instead, you apply the tools directly through exercises such as building a QTPP, identifying CQAs, running an FMEA and interpreting a design space, using realistic pharmaceutical development scenarios.

What will I be able to do after completing the course?

You will be able to construct a QTPP, identify and classify CQAs, map risks with Ishikawa and FMEA, plan and interpret DoE studies, define a design space with normal operating and proven acceptable ranges, develop a control strategy, and structure QbD evidence for CTD submissions.

Does the course prepare me for regulatory submissions?

Yes. The training shows how QbD outputs feed Section 3.2.P.2 of a CTD dossier and how a well-documented control strategy supports a more flexible post-approval change relationship under ICH Q12, aligned to what TITCK, the FDA and EMA expect.

Course Content

What topics does the Quality by Design course cover?

The course covers QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment with Ishikawa and FMEA, Design of Experiments and design space definition, Process Analytical Technology and control strategy, and QbD in practice through case studies and CTD submissions.

Does it cover both small molecules and biologics?

Yes. The course applies QbD principles to both small molecule drug products, such as tablets and injectables, and biopharmaceutical products, such as monoclonal antibodies and biosimilars, with case study examples from both.

Are Design of Experiments covered practically?

Yes. You learn how to select screening, response surface and mixture designs, run and interpret a QbD DoE, read the resulting model, and use it to define the design space and set operating ranges for consistent quality.

Is the content aligned with current ICH guidelines?

Yes. The content reflects the current ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH Q9, Q10 and Q11 quality framework, plus the CTD format used for submissions in Turkey and other ICH-aligned markets.

What materials are provided with the training?

You receive structured learning materials covering all QbD modules, worked case study examples, and hands-on exercise templates for tools such as the QTPP, CQA mapping and risk assessment, so you can apply the methods after the course.

Enrollment

How do I enrol in the Quality by Design course?

You can enrol through Invensis Learning. Choose your preferred format, confirm your place, and you will receive access to the schedule, learning materials and joining details. See upcoming batches or talk to a learning advisor to get started.

What delivery formats are available?

The course is available as online live virtual instructor-led training, classroom training, and corporate onsite delivery for teams. You can pick the format that best fits your schedule and learning preference.

How soon can I start?

Public sessions run on a regular schedule, and corporate onsite training can be arranged around your team's availability. Check the upcoming batches or ask a learning advisor about the next available dates.

Can the training be delivered onsite for my company?

Yes. We deliver onsite and live virtual corporate sessions tailored to your products and pipeline, which is especially effective when a cross-functional team applies QbD tools to live projects together. Contact us to arrange a group programme.

Can I reschedule my enrolment?

Yes. Flexible rescheduling options are available on selected plans. Contact our support team and they will help you move to a batch that works for you.