Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Quality by Design Means for Pharmaceutical TeamsA Science-Based Route to Built-In Quality

    Quality by Design Training in Armenia is a practical, one-day programme that teaches the Quality by Design (QbD) approach to pharmaceutical product and process development, where quality is engineered into the medicine from the design stage rather than tested in at the end. The course is grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines that the FDA and EMA now expect, and it shows you how to move from a Quality Target Product Profile (QTPP) to critical quality attributes, risk assessment, design of experiments and a robust control strategy. The programme suits formulation scientists, analytical scientists, process development engineers, quality assurance professionals and regulatory affairs (CMC) specialists across Armenia's growing pharmaceutical and biopharmaceutical sector. With more than half of Armenian pharmaceutical output now exported and Eurasian Economic Union GMP expectations rising, QbD fluency has become a core workplace skill for development teams. You leave able to apply QbD tools to real development scenarios straight away, with no prior QbD knowledge assumed. Build the capability your projects need with Invensis Learning.

    What Quality by Design Means for Pharmaceutical TeamsA Science-Based Route to Built-In Quality

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    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the ArmeniaWho Can Enroll?

    What You Gain from QbD TrainingSkills Your Projects Can Use Immediately

    QbD Career Paths in Armenia's Pharma SectorRoles and Rising Demand

    Quality by Design skills are becoming a core requirement across Armenia's fast-growing pharmaceutical sector, where more than half of output is exported and EAEU GMP expectations keep rising. Formulation scientists, process development engineers, analytical scientists, QA professionals and regulatory affairs specialists who can apply QbD are increasingly sought after by domestic manufacturers, API producers and biopharma developers preparing submissions for regulated markets, fuelling demand for structured Quality by Design training. Here is what the market is telling us right now.

    Market Forces Behind Rising QbD Demand in Armenia

    QbD is a practical skill your development and manufacturing projects need now. Join Armenian pharmaceutical professionals building quality in from the start. Begin today.

    Your Armenia QbD Career Shift

    Where Your Team Stands Today,

    And What QbD Skills Change

    Armenia's pharmaceutical sector is growing on the back of exports and EAEU access, and employers increasingly separate teams that can design quality in from those that only test for it. Here is which side of that line you want to be on.

    Sources: salaries.am, Statista, Armenia Ministry of Economy (Armenia) 2025-2026.

    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 Armenia 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 ProgrammeFrom QTPP to Control Strategy

    This Quality by Design training builds practical, ICH-aligned skills you can apply to pharmaceutical development straight away, across QTPP definition, CQA identification, risk assessment, design of experiments and control strategy.

    Build a Quality Target Product Profile

    Translate patient, clinical and regulatory needs into a QTPP that sets the design targets for the whole development programme, the starting point of every QbD project.

    Identify and Classify Critical Quality Attributes

    Determine which product characteristics are critical to quality, safety and efficacy, and link each CQA to the material attributes and process parameters that drive it.

    Run QbD Risk Assessments

    Apply Ishikawa (fishbone) diagrams and FMEA with severity, occurrence and detectability scoring to prioritise the variables that most affect product quality.

    Design and Interpret Experiments (DoE)

    Choose screening, response surface and mixture designs, then read the models to define a design space with Normal Operating and Proven Acceptable Ranges.

    Apply PAT and Build a Control Strategy

    Use process analytical technology and QbD outputs to assemble a control strategy spanning material, process and in-process controls that holds within the design space.

    Document QbD for Regulatory Submission

    Structure QTPP, risk assessment, design space and control strategy evidence for Section 3.2.P.2 of a CTD submission, and manage change across the product lifecycle.

    Who Should TakeQuality by Design Training in Armenia?

    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 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

    USD 345

    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.

    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

    USD 345

    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 ArmeniaTrusted, Expert-Led and Flexible

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations across Armenia, combining experienced trainers, ICH-aligned courseware and flexible delivery. Our one-day programme is built around hands-on QbD tools, from QTPP and CQA identification to risk assessment, design of experiments and control strategy. Whether you enrol as an individual or arrange corporate training for your team, we focus on real-world application and workplace outcomes, backed by ISO 9001:2015 quality and ISO 27001:2022 information-security certification.

    • ISO 9001:2015 certified quality management and ISO 27001:2022 information security
    • Experienced trainers with real pharmaceutical quality and QbD expertise
    • Live virtual, classroom and corporate on-site delivery to suit your team
    • ICH-aligned courseware covering Q8, Q9, Q10 and Q11 in a practical one-day format
    • Hands-on QTPP, CQA, risk assessment and design-space exercises, not just theory
    • Course completion record from Invensis Learning on finishing the programme
    • Dedicated learner support before, during and after training
    • Trusted by professionals and organisations across 100+ countries

    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 ArmeniaInstructor-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 Armenia

    Marriott Armenia, 1, Pap Karasavi Street, Kentron, Yerevan, 0010, Armenia

    Quality by Design Training Location in Armenia

    Radisson Blu, Azatutyan avenue, Arabkir, Yerevan, 0037, Armenia

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    Corporate QbD Training for TeamsOn-Site or Virtual, Armenia

    • Train formulation, analytical, process, quality and regulatory staff together
    • Tailored to your products, dosage forms and target export markets
    • Flexible on-site, live virtual or blended delivery around production schedules
    • ICH Q8 to Q11 aligned content mapped to your submission needs
    • Experienced pharmaceutical quality trainers with hands-on QbD exercises
    • Scalable across multiple sites and business units
    • Dedicated coordination and post-training support for your team

    Pharmaceutical Organisations in Armenia

    ArpimedEsco-PharmLiqvorPharmaTechAzad PharmaceuticalAlfa Pharm

    What Our Learners Say

    From Theory to Real Formulation Work

    "The QbD training finally connected the theory to my daily work. I can now build a QTPP, run a proper risk assessment and design a small DoE without leaning on outside consultants. The tablet case study was exactly the kind of product I develop."

    Lusine Grigoryan

    Formulation Scientist

    0/0

    Made the ICH Framework Make Sense

    "As an analytical scientist I understood testing, but not how it fits into a design space and control strategy. The trainer explained PAT and criticality in plain terms, and the hands-on exercises made the ICH guidelines click for me."

    Narek Sargsyan

    Analytical Scientist

    0/0

    Practical for CMC Submissions

    "Very useful for regulatory work. I now understand how QTPP, risk assessment and design space evidence should read in a CTD submission, which has made reviewing our development reports much faster."

    Anahit Petrosyan

    Regulatory Affairs Specialist

    0/0

    One Shared Approach Across Our Teams

    "We ran this on-site for our development and quality teams before a new export line. Everyone now shares one QbD language, and our early process work is far more structured. The trainer tailored the examples to our dosage forms."

    Aram Hovhannisyan

    Quality Assurance Manager, Generics Manufacturer

    0/0

    Flexible and Genuinely Hands-On

    "Invensis Learning delivered a well-organised corporate programme for a cross-functional group. The scheduling flexibility fit our production calendar, and the hands-on exercises meant people left able to apply QbD, not just describe it."

    Mariam Avetisyan

    Head of Learning and Development, Pharmaceutical Company

    0/0



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

    Quality by Design training is a practical, one-day course on the science-based approach to pharmaceutical product and process development, where quality is built into the medicine from the design stage rather than tested in at the end. It covers the ICH Q8(R2), Q9, Q10 and Q11 framework using tools such as QTPP, CQAs, risk assessment, DoE and control strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design training is a practical, one-day course on the science-based approach to pharmaceutical product and process development, where quality is built into the medicine from the design stage rather than tested in at the end. It covers the ICH Q8(R2), Q9, Q10 and Q11 framework using tools such as QTPP, CQAs, risk assessment, DoE and control strategy.

    Who should attend QbD training in Armenia?

    The course suits formulation scientists, analytical scientists, process development engineers, quality assurance professionals and regulatory affairs (CMC) specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations. It is ideal for teams across Armenia preparing products and submissions for EAEU and other regulated markets.

    Is Quality by Design worth learning for pharma professionals in Armenia?

    Yes. With more than half of Armenian pharmaceutical output exported and EAEU GMP expectations rising, QbD has become a core workplace skill. Professionals who can design quality in, define design spaces and build control strategies are increasingly valued by manufacturers and developers.

    Which standards and guidelines does the course follow?

    The training is grounded in the ICH Quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. These are the QbD expectations that the FDA, EMA and EAEU regulators apply to modern development submissions.

    Do I need prior QbD experience to attend?

    No prior QbD experience is required. The course introduces QbD from first principles in a pharmaceutical development context. Familiarity with pharmaceutical development or GMP is helpful but not essential.

    Pricing

    How much does QbD training in Armenia cost?

    Pricing varies by delivery mode, group size and whether you enrol individually or as a corporate team. Contact us for current figures for Armenia, and we will share a tailored quote. Request a quote to see the option that fits your needs.

    What is included in the course fee?

    The fee typically includes instructor-led sessions across all six QbD modules, ICH-aligned courseware, hands-on tool exercises (QTPP, CQA identification, risk assessment and design-space interpretation), case studies and learner support, plus a course completion record from Invensis Learning.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with tailored content and volume-based pricing for development, quality and regulatory teams. It can be delivered on-site or live virtual. Ask about corporate pricing for your team.

    In which currency is the training billed?

    Training for teams in Armenia can be quoted to suit your organisation, and pricing depends on the format and group size. Speak with a learning advisor for a quote in the currency that works best for you.

    How do I request a quote for QbD training?

    Share your team size, preferred format and dates through the enquiry form, and a learning advisor will send a tailored quote. Talk to a learning advisor to plan a schedule that fits your projects.

    Assessment

    Is there an exam or test to pass?

    No. This is a non-certification skills course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion during the one-day programme.

    Do I receive a certificate after the training?

    Participants receive a course completion record from Invensis Learning after finishing the programme. This is a record of attendance and learning, not a formal credential from an external awarding body.

    Is QbD training a certification?

    No. QbD training is a practical, non-certification programme focused on building workplace skills. There is no governing body, no formal credential and no examination associated with the course.

    How is learning reinforced during the course?

    Learning is applied throughout the day through QTPP construction, CQA identification, Ishikawa and FMEA risk assessment, DoE design selection and design-space interpretation, all using realistic pharmaceutical development scenarios rather than a formal test.

    Will the training help with regulatory submissions?

    Yes. You learn how QbD outputs (QTPP, CQAs, design space and control strategy) form Section 3.2.P.2 of a CTD submission, so you can prepare and review development documentation that meets ICH-aligned regulator expectations.

    Course Content

    What topics does the QbD course cover?

    The course covers QbD principles and the ICH regulatory context, QTPP and CQAs, risk assessment (Ishikawa and FMEA), design of experiments and design space, process analytical technology and control strategy, plus QbD in practice through small molecule and biologic case studies.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, run risk assessments with Ishikawa diagrams and FMEA, plan and interpret a DoE, define a design space with NOR and PAR, and develop a control strategy for regulatory submission.

    Does the course include hands-on exercises?

    Yes. Hands-on QbD tool exercises run throughout the day, applying QTPP construction, CQA identification, risk assessment and design-space interpretation to realistic pharmaceutical development scenarios so you can use the tools immediately.

    Does it cover both small molecule and biologic products?

    Yes. The training covers QbD principles for small molecule drug products such as tablets, capsules and injectables, and for biopharmaceutical products such as monoclonal antibodies and biosimilars, with worked case study examples from both.

    How long is the QbD training?

    The programme runs for one day (eight hours) and covers all six QbD modules, from principles and the ICH framework through QTPP, CQAs, risk assessment, DoE, PAT and control strategy, with hands-on exercises throughout.

    Enrollment

    How do I enrol in QbD training in Armenia?

    You can enrol through the Invensis Learning website or the enquiry form. Choose your preferred format, and you will receive access to schedules, courseware and learning resources. See upcoming batches to get started.

    What delivery formats are available?

    QbD training is available as online (live virtual) instructor-led sessions, in-person classroom training, and customised corporate on-site programmes, so you can choose the format that fits your schedule and team.

    Can the course be delivered on-site for our team?

    Yes. Corporate on-site delivery is available for pharmaceutical teams in Armenia and is particularly effective when a cross-functional group applies QbD tools to their own live development projects during the session. Ask about corporate or group options.

    When are the upcoming batches?

    New public and corporate sessions are scheduled regularly in live virtual and classroom formats. Contact a learning advisor for the current Armenia schedule and to reserve places for your team.

    Can I reschedule my enrolment?

    Yes. Flexible options let you reschedule or transfer to another batch. Contact our support team to arrange a date that works for you and your projects.