Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design Training in Lithuania?

    Designing Quality into Every Batch

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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 Lithuania

    Who Can Enrol?

    Why QbD Skills Pay off on the Job

    Practical Value from Day One

    Who Should Take Quality by Design Training in Lithuania?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    How QbD Skills Advance Your Pharma Career

    Roles, Demand and Pay

    Quality by Design has become a core capability across Lithuania's life sciences sector, valued by biopharma manufacturers, CDMOs, API producers and regulatory teams that export most of their output to the EU, US and Japan. As the sector grows 20 to 25% a year and campuses like Bio City scale, professionals who can design quality in are increasingly sought after. Quality by Design training is how professionals build exactly that capability. Demand spans analytical and formulation science through to QA, process development and CMC roles, and here is what the market is telling us now.

    What Is Driving Demand for QbD Skills in Lithuania

    Quality by Design is fast becoming a baseline skill for pharmaceutical development in Lithuania. Build applied QbD capability your team can use on live projects. Start your training with Invensis Learning today.

    Your Lithuania Career Shift

    Your Skills Before and After the Training

    The on the Job Difference QbD Makes

    Lithuania's life sciences sector is growing 20 to 25% a year, and employers increasingly want people who can design quality in rather than test it in. Here is what changes once you can apply Quality by Design end to end.

    Sources: WorldSalaries, PayScale, Manoalga.lt (Lithuania) 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 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 Lithuania 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 QbD Training

    The Full QbD Toolkit in One Day

    This training gives pharmaceutical and biopharmaceutical professionals hands on command of the full QbD toolkit. By the end of the one day programme you can define a QTPP, run risk assessment, plan DoE, define a design space and set a control strategy on your own products.

    Set the QTPP and Identify CQAs

    Construct a Quality Target Product Profile from patient and clinical needs, then identify and classify Critical Quality Attributes for both small molecule and biologic products.

    Run Risk Assessments with FMEA and Ishikawa

    Map Critical Material Attributes and Critical Process Parameters to each CQA, then prioritise them using Ishikawa diagrams and FMEA with Severity, Occurrence, Detectability and RPN scoring.

    Design and Interpret DoE Studies

    Select screening and response surface designs, run and analyse a QbD Design of Experiments, and define the design space along with Normal Operating Ranges and Proven Acceptable Ranges.

    Apply PAT for Real Time Control

    Use Process Analytical Technology tools such as NIR, Raman and FBRM to monitor CQAs during manufacturing and understand how PAT enables real time release testing.

    Build a Risk Based Control Strategy

    Turn risk assessment and DoE outputs into a holistic control strategy covering material, process and in process controls, PAT monitoring and periodic review.

    Structure QbD for Regulatory Submission

    Present QbD evidence in the CTD, including Section 3.2.P.2 Pharmaceutical Development, and manage the lifecycle and post approval changes 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

    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 QbD Training

    Expert Led Training That Applies at Work

    Invensis Learning delivers structured Quality by Design training for individual professionals and pharmaceutical teams that want to build QbD capability aligned to the ICH framework. Our programmes combine experienced trainers, real world case studies, organised courseware and hands on tool exercises. As a trusted Quality by Design training company in Lithuania, we focus on the capability you can apply straight away. Whether you enrol as an individual learner in Lithuania or plan corporate training for a cross functional development team, Invensis Learning provides a professional training experience built around practical understanding, real world application and measurable learning outcomes.

    • Experienced trainers with pharmaceutical and biopharma quality expertise
    • Instruction aligned to the ICH Q8, Q9, Q10 and Q11 guidelines
    • Flexible formats: classroom, live virtual online and corporate onsite
    • Real pharmaceutical case studies for small molecules and biologics
    • Hands on QbD tool exercises using realistic development scenarios
    • Structured courseware and practical, workplace ready learning
    • Dedicated learner support before, during and after the training
    • ISO 9001:2015 and ISO 27001:2022 certified training operations

    500+

    Corporate Clients

    12+

    Years of Training Excellence

    24/7

    Learner Support

    50+

    Industries Served

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

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    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 Lithuania

    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 Lithuania

    Radisson Blu Hotel Lietuva, 20, Konstitucijos pr., Skansenas, Šnipiškii seniūnija, Vilnius, Vilnius city municipality, Vilnius district, 09308, Lithuania

    Quality by Design Training Location in Lithuania

    Grand Hotel Kempinski Vilnius, Lithuania

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    Corporate QbD Training for Pharma Teams

    For Your Teams

    • Tailored QbD curriculum built around your own products and processes
    • Delivered onsite in Lithuania, live virtual, or in a blended format
    • Trainers with real pharmaceutical and biopharma QbD experience
    • Flexible schedules that fit shift patterns and project workloads
    • Group rates and volume based pricing for teams and departments
    • Progress tracking and post training support for every learner
    • Scalable delivery for local, regional and multi site teams

    Trusted by Leading Enterprises in Lithuania

    Thermo Fisher Scientific BalticsTeva BalticsNorthway BiotechBiotechpharmaSanitasCasZyme

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

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

    Quality by Design Training Course in KlaipedaQuality by Design Training Course in Vilnius

    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design Training is a practical, one day skills course on the QbD approach to pharmaceutical product and process development. It suits formulation scientists, process development engineers, analytical scientists, QA professionals and regulatory affairs (CMC) specialists who want to design quality into products from the outset.