Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why Pharma Teams Rely on It

    A Science-Based Path to Product Quality

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    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Turkey

    Who Can Enrol?

    What You Gain from Mastering Quality by Design

    Skills You Apply from the Next Project

    Who Should Take Quality by Design Training in Turkey?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where Quality by Design Skills Take Your Career in Turkey

    Roles, 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.

    Market Forces Making QbD Skills Essential in Turkey

    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.

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

    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 optimisation
    • 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 Curriculum

    of 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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    The QbD Capabilities You Will Build

    Tools 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.

    Quality by Design Training Modes

    for 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

    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.

    Quality by Design Corporate Group Training

    • Customised training aligned to organisational 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

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

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

    Quality by Design Focused 1-to-1 Training

    • One-to-one instructor attention

    • Customised 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

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

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

    Quality by Design Live Virtual Training

    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

    Starts from

    TRY 16390

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

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

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    Why Choose Invensis Learning for Quality by Design Training in Turkey

    Expert-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 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

    Quality by Design Training Locations in Turkey

    Instructor-led in-person Classroom training is available for group batches. All other public cohorts are delivered as Instructor-led Live Virtual. See available cohorts.

    Quality by Design Training Location in Turkey

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

    Quality by Design Training Location in Turkey

    Swissotel The Bosphorus Istanbul, Turkey

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    Corporate Quality by Design Training for Your Team

    Build QbD Capability Across Your Organisation

    • 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

    Trusted by Leading Enterprises in Turkey

    Abdi IbrahimDeva HoldingBilim IlacKocak FarmaSanovelNobel Ilac

    Enquire with us now

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    We also deliver Quality by Design Training across multiple cities in Turkey

    Quality by Design training for individuals and teams. Select a city in Turkey to view upcoming dates, formats and pricing.

    Quality by Design Training Course in AnkaraQuality by Design Training Course in AntalyaQuality by Design Training Course in BursaQuality by Design Training Course in GaziantepQuality by Design Training Course in IstanbulQuality by Design Training Course in Kocaeli

    Frequently Asked Questions

    Here'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.

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