Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Quality by Design Means for Pharmaceutical Teams

    A Science-Based Route to Built-In 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 Armenia

    Who Can Enrol?

    What You Gain from QbD Training

    Skills Your Projects Can Use Immediately

    Who Should Take Quality by Design Training in Armenia?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    QbD Career Paths in Armenia's Pharma Sector

    Roles 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 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 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 Programme

    From 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.

    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

    USD 325

    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 Armenia

    Trusted, 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 Armenia

    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 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 Teams

    On-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

    Trusted by Leading Enterprises in Armenia

    ArpimedEsco-PharmLiqvorPharmaTechAzad PharmaceuticalAlfa Pharm

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    What Our Learners Say About Us

    "Respective communication, steady pace of the class, not too fast but as well not too slow. A lot of space for open discussions and questionings. its not 5/5 because I believe the sessions consist of too much information for such short time. It could be organized in 1 more day, with less information per day, to have a better understanding."

    Marianne Van der Veken

    (4.0/5)

    BelgiumTrustpilot

    "It was a pleasur working and learning from Pritesh Shah. He managed to pick up where I was standing and helped me understand from the ground on. I am very greatful he managed to help me in that way. It is absolutely worth the money."

    Kaltrina

    (5.0/5)

    SwitzerlandTrustpilot

    "Ease of navigation and very knowledgeable instructor"

    Terrence Brown

    (4.0/5)

    United StatesTrustpilot

    "This is a good conduct of the information contained in e-mail for me ."

    Sanchita Parashar

    (5.0/5)

    NetherlandsTrustpilot

    "It's a good learning experience with Pritesh! He spent time to help me going through both 7th and 8th edition and giving exam tips. Appreciate it!"

    Rachel Valentina

    (5.0/5)

    "Great traininer and material."

    Andrea

    (5.0/5)

    HungaryTrustpilot

    "It was a good experienced and he did great of using real world examples that I was able to relate to. Pritesh were Explaining with extra slides in my work area. "

    Victor Hamman

    (5.0/5)

    South AfricaTrustpilot

    "The instructor is very knowledgeable and shared variety of examples to explain different concepts. The training was tailored to my understanding level which was very helpful. I had plenty of flexibility in break time as well as scheduling these sessions with my medical issues. Very grateful for this training and all the tips and additional materials. Thank you"

    Palak Ray

    (5.0/5)

    AustraliaTrustpilot


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    Frequently Asked Questions

    Here'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.