Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters in PharmaYour Route to Built-In Product Quality

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the LatviaWho Can Enroll?

    Why This QbD Training Is Worth Your TimeThe On-The-Job Value of QbD Skills

    Where QbD Takes Your Career in LatviaIn-Demand Pharma and CDMO Roles

    Quality by Design skills are increasingly valued across Latvia's pharmaceutical and life sciences sector, from established manufacturers to fast-growing CDMOs. As EU-GMP and EMA-aligned production expands around Riga and Olaine and regulators expect more QbD evidence in submissions, professionals who can design quality into products are in demand. Roles span formulation, analytical and process development, quality assurance and regulatory affairs, and here is what the market shows.

    Market Forces Making QbD Skills Valuable in Latvia

    QbD is a practical, science-based skill that pharmaceutical teams in Latvia increasingly need. Build the capability to design quality in and lead development with confidence. Start your journey today.

    Your Latvia QbD Career Shift

    From Empirical Development to Designed-In Quality

    The Shift QbD Skills Deliver

    Latvia's pharmaceutical sector is moving towards science-based, ICH-aligned development, and employers increasingly value professionals who can design quality in rather than test it in. Here is how QbD skills change where you stand.

    Sources: Algas.lv, SalaryExpert, EuroPharmaJobs (Latvia) 2025-2026.

    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 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 Latvia 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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    Skills You Will Build in This QbD TrainingQTPP, DoE and Control Strategy Tools

    This Quality by Design training teaches you to apply the full QbD toolkit to real pharmaceutical development, from defining product goals through to a documented control strategy. By the end you can lead QbD activities across formulation, process and quality work.

    Quality Target Product Profile (QTPP)

    Construct a QTPP from clinical and patient needs, translating the intended use of a product into clear, measurable quality goals that anchor the whole QbD programme.

    Critical Quality Attributes (CQAs)

    Identify and classify the physical, chemical, biological and microbiological attributes critical to product quality, safety and efficacy, and link them to material and process inputs.

    Quality Risk Management

    Apply Ishikawa (fishbone) diagrams and FMEA with Risk Priority Numbers to rank how material attributes and process parameters affect each CQA, focusing effort where it counts, per ICH Q9.

    Design of Experiments and Design Space

    Use screening and response surface designs to understand factor effects, then define a design space with Normal Operating and Proven Acceptable Ranges that assures quality.

    Process Analytical Technology (PAT)

    Understand how in-line tools such as NIR and Raman enable real-time monitoring and real-time release testing, replacing reliance on end-product testing.

    Control Strategy and Submissions

    Build a control strategy from your risk assessment and DoE results, and structure QbD evidence for the pharmaceutical development section of a CTD submission.

    Who Should TakeQuality by Design Training in Latvia?

    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

    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

    • 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

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

    • 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

    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

    EUR 300

    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 LatviaExpert-Led, Flexible and Practical

    Invensis Learning delivers practical, instructor-led Quality by Design training for individuals and pharmaceutical teams in Latvia. Our trainers are experienced quality management practitioners, and our programmes are built around real pharmaceutical development scenarios rather than theory. Whether you enrol as an individual or arrange corporate training for your team, you get structured courseware, hands-on QbD tool exercises and learner support before, during and after the session. As an ISO 9001:2015 and ISO 27001:2022 quality-assured training organisation and a trusted Quality by Design training company in Latvia, we deliver a professional learning experience you can rely on.

    • Experienced quality management trainers with real pharmaceutical and process expertise
    • Hands-on QbD exercises using realistic pharmaceutical development scenarios
    • Flexible formats: live virtual, classroom, onsite and corporate group training
    • Structured, practical courseware focused on workplace application
    • Dedicated learner support before, during and after the training
    • ISO 9001:2015 and ISO 27001:2022 quality-assured training delivery
    • Scalable delivery for local and global pharmaceutical teams
    • Competitive pricing for individual and corporate learners

    1-to-1

    Doubt-Clearing Sessions

    60+

    Global Course Portfolio

    100+

    Countries Served

    ISO 9001

    Quality Management

    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 LatviaInstructor-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 Latvia

    Radisson Blu - Hotel Latvija, 55, Elizabetes iela, Centra district, Centrs, Centra area, Riga, LV-1010, Latvia

    Quality by Design Training Location in Latvia

    Grand Palace Hotel, 12, Pils iela, Old Riga, Latgale neighborhood, Riga, LV-1050, Latvia

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    Corporate QbD Training for TeamsUpskill Your Pharma Team

    • Customised QbD training for R&D, manufacturing, quality and regulatory teams
    • Flexible delivery through onsite, live virtual, hybrid or blended formats
    • Schedules aligned to your team's production and project availability
    • Role-based pharmaceutical examples for direct workplace application
    • Experienced trainers with pharmaceutical quality and process expertise
    • Dedicated coordination and support for group training programmes
    • Scalable delivery for teams across Latvia and global sites

    Trusted by Life Sciences Teams

    GrindeksOlphaPharmIdeaKalceksSilvanolsLotos Pharma

    What Our Learners Say

    Practical from the First Module

    "The QbD training finally connected the ICH guidelines to what I do day to day. I can now build a QTPP, map CQAs and plan a DoE with real confidence, and I have already used it on a live formulation project."

    Ilze Berzina

    Formulation Scientist

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    Design Space Made Clear

    "The sessions on Design of Experiments and design space were exactly what my scale-up work needed. Working through realistic scenarios made the difference, and I understand Normal Operating and Proven Acceptable Ranges far better now."

    Janis Ozolins

    Process Development Engineer

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    Strong on the Regulatory Angle

    "As a regulatory affairs specialist, the module on structuring QbD evidence for the pharmaceutical development section of a submission was genuinely useful. The trainer answered every question and kept it grounded in ICH Q8, Q9 and Q10."

    Anna Kalnina

    Regulatory Affairs Specialist

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    A Shared Language for Our Teams

    "We ran the training onsite for our quality and process teams. It gave everyone a shared QbD language, and we have already reduced friction between development and manufacturing on risk assessment and control strategy."

    Maris Liepins

    Quality Assurance Manager, Pharmaceutical Manufacturer

    0/0

    Tailored and Well Organised

    "Invensis Learning tailored the QbD programme to our CDMO context and scheduled it around production. The cross-functional format worked well, and our teams now apply QTPP and FMEA consistently across projects."

    Kristine Vitola

    Head of Learning and Development, CDMO

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    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

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    We also deliver Quality by Design Training across multiple cities

    Invensis Learning delivers industry-leading Quality by Design training solutions tailored for individuals and organizations.

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

    Quality by Design training is a practical, non-certification course that teaches a systematic, science-based approach to pharmaceutical development, where quality is built into the product from the design stage. It covers the QbD framework and the ICH Q8, Q9, Q10 and Q11 guidelines, including QTPP, CQAs, risk assessment, Design of Experiments, PAT and control strategy.