Quality by Design Training in Latvia

Design Quality in, Not Test It In

Instructor-led Quality by Design training for pharmaceutical and biopharmaceutical professionals in Latvia. Learn to apply the ICH Q8, Q9, Q10 and Q11 framework and build quality into products from the development stage, using QTPP, Critical Quality Attributes, risk assessment, Design of Experiments and a robust control strategy.

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Hours

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Master Quality by Design and Lead Excellence in Latvia

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

Quality by Design (QbD) is 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. This Quality by Design Training in Latvia gives scientists, engineers and quality professionals a practical command of the QbD framework so they can design robust products and processes with confidence.

The programme is grounded in the ICH Quality guidelines: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. Together these form the QbD approach that the FDA and EMA increasingly expect in modern development and manufacturing submissions. You learn to define the Quality Target Product Profile, identify Critical Quality Attributes, run risk assessments, use Design of Experiments to establish a design space, and build a control strategy.

Delivered in live virtual, classroom and corporate formats, this one-day programme suits professionals across Riga, Olaine and Latvia's wider life sciences sector. Start building QbD capability with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Latvia is designed to help learners understand QbD principles, regulatory frameworks, and pharmaceutical product development methodologies covered in the program
Course content aligned with current ICH Q8, Q9, and Q10 guideline expectations, real-world pharmaceutical quality requirements, and practical learning objectives for Latvia professionals delivered through a comprehensive Quality by Design training program
Real-world examples and scenario-based learning to help learners connect QbD concepts with everyday pharmaceutical development, manufacturing, and quality assurance situations
Guided learning support to help participants strengthen understanding, improve confidence, and apply QbD principles effectively across product development and manufacturing roles

Structured Courseware and Learning Resources

Access to organized QbD course materials including QTPP definition worksheets, CQA and CMA identification templates, CPP mapping guides, and DoE reference cards designed to support step-by-step learning
Topic-wise learning resources, exercises, and knowledge checks to reinforce understanding of Design Space, control strategies, and risk assessment tools
Practice activities, assignments, and scenario-based exercises to help learners apply QbD concepts in realistic pharmaceutical product development and manufacturing quality situations
Supplementary learning aids such as risk assessment matrices, Design Space configuration worksheets, RTRT implementation checklists, and control strategy development guides

Instructor-Led, Practical Learning Experience

Live interactive sessions delivered by experienced QbD practitioners with hands-on domain expertise across pharmaceutical, biotechnology, and manufacturing sectors
Real-world examples, case discussions, and applied QbD exercises to improve practical understanding of QTPP definition, CQA identification, DoE applications, and Design Space configuration
Opportunities to ask questions, clarify doubts, and participate in trainer-led discussions on risk assessment, CPP mapping, and regulatory compliance requirements
Training approach focused on helping learners apply QbD concepts confidently at work, not just complete the course content

Flexible Learning Support in Latvia

Instructor-led training formats available for individual learners and corporate teams across the Latvia
Options include live virtual classroom training, onsite training, and customized group training depending on availability and organizational requirements
Learning support designed to help participants stay on track before, during, and after the Quality by Design training
Additional revision and post-training support may be available based on the selected course format

Learn the Core Concepts Covered in the Course

Understand QbD fundamentals, background, key drivers, and the regulatory guidance documents including ICH Q8, Q9, and Q10 that shape modern pharmaceutical development
Learn how to define QTPP, identify CQAs, CMAs, and CPPs, apply DoE, configure Design Space, and develop control strategies based on the course curriculum
Explore practical use cases showing how QbD is applied in pharmaceutical, biotechnology, healthcare, and manufacturing environments
Build role-relevant knowledge of risk assessment and management, real-time release testing, and regulatory compliance that supports better quality decisions in product development

Practice, Assessment, and Completion Support

Practice defining QTPP, identifying CQAs and CMAs, mapping CPPs, and applying DoE through exercises and scenario-based activities
Use assessments to identify knowledge gaps in QbD concepts and strengthen understanding of Design Space and control strategy development
Receive guidance from instructors to improve understanding of QbD tools and stay aligned with course objectives
Earn a course completion certificate after successfully meeting the training requirements

Career and Workplace Application

Build practical QbD skills that can support career growth, role advancement, or improved pharmaceutical quality performance in the Latvia
Strengthen confidence in applying QTPP definition, CQA identification, DoE, Design Space, and risk management concepts to real-world product development challenges
Improve professional credibility through structured, skill-focused Quality by Design training recognized across Latvia pharmaceutical and manufacturing industries
Support enterprise capability building through Quality by Design corporate training for employees across pharmaceutical, biotechnology, healthcare, and manufacturing organizations.

Quality by Design Training Eligibility in the LatviaWho Can Enroll?

No formal prerequisites are required to enroll in the Quality by Design training program
Basic familiarity with quality assurance concepts is helpful but not mandatory for enrollment
Professionals from pharmaceutical, biotechnology, healthcare, and manufacturing industries are well-suited for this training
Individuals and corporate teams seeking to build QbD knowledge and apply regulatory-aligned product development principles are eligible to enroll
Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

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

For Individuals

Quality by Design training helps pharmaceutical and biopharmaceutical professionals move from trial-and-error development to a systematic, science-based approach. You gain hands-on skills in QTPP, CQA identification, risk assessment, DoE and control strategy that apply directly to your development projects. Whether you work in formulation, analytical development, process engineering, quality assurance or regulatory affairs, the training builds capability you can use immediately in Latvia's pharma and CDMO sector.

If you want to design robust products, reduce manufacturing deviations and support regulatory submissions with sound process understanding, QbD is a core skill. You leave able to lead QbD activities and connect development decisions to consistent product quality.

Apply QbD from the first stage of development instead of relying on end-product testing
Build Quality Target Product Profiles and identify Critical Quality Attributes with confidence
Run structured risk assessments using Ishikawa diagrams and FMEA to focus your effort
Use Design of Experiments to define a design space and prove real process understanding
Develop control strategies that hold quality steady across scale-up and manufacturing
Speak the ICH Q8, Q9, Q10 and Q11 language that regulators and reviewers expect
Contribute to stronger CTD submissions and smoother post-approval change management
Become the person your team turns to for QbD on live development projects

For Organizations

Quality by Design group training helps pharmaceutical and biopharmaceutical organisations in Latvia build consistent, science-based development practice. Teams learn to apply the QbD framework and ICH guidelines to their own products, creating a shared approach to quality across departments. The training can be delivered for R&D, manufacturing, quality and regulatory teams together, so QbD becomes a common language rather than an individual skill.

For organisations facing regulatory expectations, scale-up challenges or costly deviations, QbD group training provides a scalable, flexible route to stronger process understanding, more robust submissions and more consistent product quality.

Standardise QbD practice across formulation, analytical, process and quality teams
Reduce deviations and out-of-specification results through better process understanding
Strengthen ICH-aligned development and support smoother FDA and EMA submissions
Build design spaces that give production flexibility and cut post-approval change burden
Upskill cross-functional teams together on live product development projects
Embed risk-based decision-making across the pharmaceutical quality system
Deliver training onsite, live virtual or blended to fit production schedules
Build lasting in-house QbD capability across business units

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.

EUR 314M

Pharmaceutical sector turnover, Latvia

2022, Invest in Latvia

27%

Pharma share of industrial exports

2023, Invest in Latvia

EUR 1,029-2,658

Process Engineer net pay, Latvia

per month, Algas.lv 2026

Pharma operators based in Latvia

most near Riga, industry data

SECTORS HIRING

—Pharmaceutical Manufacturing and Generics
—Contract Development and Manufacturing (CDMO)
—Active Pharmaceutical Ingredient (API) Production
—Biopharmaceutical and Life Sciences R&D
—Regulatory Affairs and Quality Assurance
—Analytical and Process Development

GROWTH TRENDS

—EU-GMP and EMA-aligned manufacturing drawing pharma investment
—Small-molecule and CDMO capacity expanding around Riga and Olaine
—Pharma a major share of Latvia's industrial exports
—Rising regulatory expectation for QbD evidence in submissions
—Organic synthesis and generics heritage anchored by the Institute of Organic Synthesis
—Skilled, cost-competitive workforce attracting contract manufacturing

Sources: Invest in Latvia, LIAA, Algas.lv, EuroPharmaJobs, Baltic biotech industry data 2025-2026.

Designation

Quality by Design Professionals in Latvia : Salary Insights and Trends

Hiring Companies in Latvia

€18K

Min

€24K

Average

€36K

Max

Algas.lv · SalaryExpert · EuroPharmaJobs (Latvia)

GrindeksOlphaKalceksPharmIdea

Source: Grindeks · Olpha · Kalceks · PharmIdea

Market Forces Making QbD Skills Valuable in Latvia

Rising Regulatory Expectations

The FDA and EMA increasingly expect QbD evidence in development submissions, yet many teams still work empirically. QbD closes that gap by grounding development in ICH Q8, Q9, Q10 and Q11.

QbD builds ICH-aligned development skills

The Cost of Test-And-Fix

Relying on end-product testing to catch defects drives deviations and rework. QbD builds quality in from the design stage, reducing out-of-specification results and costly failures.

QbD replaces end-product testing with understanding

Scale-Up and Transfer Risk

Moving from development to commercial scale often introduces variability. A defined design space and control strategy give teams the process understanding to scale up predictably.

QbD builds design space and control skills

CDMO Competitiveness

Latvia's growing CDMO sector competes on quality and compliance. QbD expertise is a differentiating capability that reassures clients and supports EU-GMP manufacturing.

QbD is a differentiating CDMO capability

QbD Talent Shortage

Latvia has deep chemistry and pharma talent but fewer professionals trained in structured QbD tools. Those who can lead QTPP, DoE and risk assessment work are sought after.

QbD makes skilled professionals stand out

Post-Approval Change Burden

Rigid processes make every manufacturing change a regulatory event. A well-justified design space lets teams operate flexibly and cut the post-approval change burden.

QbD reduces regulatory change effort

Sources: Invest in Latvia, LIAA, trade.gov Latvia commercial guide, ICH and EMA guidance 2025-2026.

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.

Today

Pay and progression capped by a narrow development skill set

After QbD

Skilled QbD professionals command competitive pharma pay in Latvia's growing sector

Today

Pay and progression capped by a narrow development skill set

Today

Shortlisted less often for QbD-focused development roles

After QbD

Eligible for formulation, process, QA and regulatory roles that value QbD

Today

Shortlisted less often for QbD-focused development roles

Today

Confident in the lab, but less so on design space and control strategy

After QbD

Able to lead QTPP, DoE, risk assessment and control strategy work

Today

Confident in the lab, but less so on design space and control strategy

You build QbD capability

Before

Development driven by trial and error and end-product testing

Now you have

A structured, science-based QbD approach to product and process design

Before

Development driven by trial and error and end-product testing

Before

Limited fluency in the ICH guidelines behind modern submissions

Now you have

Command of the ICH Q8, Q9, Q10 and Q11 framework regulators expect

Before

Limited fluency in the ICH guidelines behind modern submissions

Before

Quality checked at the end, with problems found too late

Now you have

Quality designed in from the start, with fewer late-stage deviations

Before

Quality checked at the end, with problems found too late

Before

Recognition tied to job title rather than demonstrable QbD skill

Now you have

A practical QbD skill set valued across pharma and CDMOs in Latvia

Before

Recognition tied to job title rather than demonstrable QbD skill

"The gap between running experiments and designing quality in is a set of practical QbD skills, and the organisations that matter already know it."

Join the professionals who trained with Invensis Learning and made the shift.

Sources: Algas.lv, SalaryExpert, EuroPharmaJobs (Latvia) 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 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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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

Shifts your thinking from testing quality in at the end to designing it in from the start.

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

Shifts your thinking from testing quality in at the end to designing it in from the start.

100% Secure and Safe download

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

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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.

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Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

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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

EUR 400

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

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

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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

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

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

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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

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

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

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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

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Please Note: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.

Loading schedules…

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 27001:2022 Certified

Secure SSL Encryption

Leaders in Training industry for 12+ years

Over 5000 five star reviews

Level AA conformance, W3C WCAG 2.2

Quality by Design Training Locations in LatviaAll our classroom training is now available online at your convenience

Quality by Design in Latvia

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

Quality by Design in Latvia

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

Quality by Design in Latvia

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

Quality by Design in Latvia

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

Corporate QbD Training for TeamsUpskill Your Pharma Team

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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

What Our Learners Say

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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

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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

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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

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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

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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

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4.6

Ratings

100K+

Happy Learners

100+

Locations Worldwide

99%

Training Satisfaction

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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.

General

What is Quality by Design (QbD) training?

Is Quality by Design training worth it?

Yes. QbD is increasingly expected by the FDA and EMA and is valued across Latvia's pharma and CDMO sector. The skills apply immediately to development projects, helping you design robust products, cut deviations and support stronger regulatory submissions, which makes QbD-capable professionals sought after.

Who should attend this QbD training?

The training suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals, and regulatory affairs (CMC) specialists in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to understand and apply QbD.

Do I need prior experience to take QbD training?

No formal prerequisites are required. Familiarity with pharmaceutical development or GMP is helpful but not essential, as the course introduces QbD from first principles in a pharmaceutical development context.

Which standards and guidelines does the course follow?

The course is grounded in the ICH Quality guidelines: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, the framework the FDA and EMA expect in modern development submissions.

How long is the Quality by Design training?

The course runs as a one-day, eight-hour programme covering all six QbD modules, from principles and the ICH framework through QTPP, CQAs, risk assessment, DoE, PAT and control strategy, with hands-on tool exercises throughout.

Pricing

How much does Quality by Design training cost in Latvia?

Course fees vary by delivery format (live virtual, classroom or corporate) and group size, so pricing for training in Latvia is available on request. Contact a learning advisor for a tailored quote.

What is included in the course fee?

The fee typically includes instructor-led training across all six QbD modules, structured courseware, hands-on tool exercises, learner support and a course completion certificate from Invensis Learning. Request a quote for the full inclusions.

Do you offer group or corporate pricing?

Yes. We offer corporate group training with customised schedules and volume-based pricing for pharmaceutical teams. Ask about corporate or group pricing to train your team together.

What payment methods are available?

We accept major credit and debit cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to choose the option that suits you.

Are there any exam or membership fees to pay?

No. This is a non-certification training course with no examination and no external body, so there are no exam or membership fees. You pay only the course fee for your chosen format.

Assessment

Is there an exam for Quality by Design training?

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

Do I receive a certificate after the training?

You receive a course completion certificate from Invensis Learning after finishing the programme. It is a record of attendance and learning, not a credential from an external awarding body, as QbD training has none.

How is learning assessed during the course?

There is no formal assessment. You apply QbD tools such as QTPP construction, CQA identification, Ishikawa diagrams and DoE design to realistic development scenarios throughout the day, so learning is reinforced through practice.

What will I be able to do after the training?

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

Is the training suitable for both small molecules and biologics?

Yes. The course covers QbD principles for small molecule drug products and biopharmaceuticals, with case study examples for both, including CQAs such as dissolution and impurities for small molecules and glycosylation and aggregation for biologics.

Course Content

What will I learn in Quality by Design training?

You will learn to apply the full QbD framework: defining the Quality Target Product Profile, identifying Critical Quality Attributes, conducting risk assessment, using Design of Experiments to define a design space, applying Process Analytical Technology, and building a control strategy.

What topics are covered in the syllabus?

The syllabus spans six modules: QbD principles and the ICH framework; QTPP and CQAs; risk assessment; DoE and design space; PAT and control strategy; and QbD in practice, covering case studies, CTD submissions and lifecycle management.

Does the course include hands-on exercises?

Yes. Hands-on QbD tool exercises run throughout, including QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams, DoE design selection and design space interpretation, all applied to realistic pharmaceutical scenarios.

Does it cover ICH guidelines and regulatory submission?

Yes. The course covers ICH Q8, Q9, Q10 and Q11 and shows how QbD outputs form the pharmaceutical development section (3.2.P.2) of a CTD submission, plus post-approval change management under ICH Q12.

What learning materials are provided?

You receive structured courseware covering all six modules, worked pharmaceutical case studies, tool templates and exercise materials to support hands-on practice during and after the session.

Enrollment

How do I enrol in the Quality by Design course?

You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you receive access to schedules, courseware and learning resources. Talk to a learning advisor to get started.

What training formats are available?

The course is available online (live virtual instructor-led), in classroom, onsite, and as customised corporate group training, so you can choose the format that fits your schedule and your team.

How soon can I start the training?

New live virtual and classroom sessions run regularly, and corporate sessions are scheduled to fit your team. See upcoming batches or ask a learning advisor about the next available dates in Latvia.

Can I reschedule or transfer my enrolment?

Yes. Flexi options let you reschedule or transfer to another batch on selected plans. Contact support to arrange this without hassle.

What is the refund or cancellation policy?

Refunds and cancellations follow our published policy, and selected plans include a money-back option. Reach out to our team for the details that apply to your enrolment.