Quality by Design Training in Kenya

Design Quality into Every Formulation

Give pharmaceutical and biopharma teams in Kenya the QbD skills that regulators now expect. This instructor-led programme shows formulation, quality and regulatory professionals how to apply the ICH Q8 to Q11 framework, build the QTPP, identify critical quality attributes, run risk assessment and Design of Experiments, and set a robust control strategy for stronger regulatory submissions.

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Hours

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Master Quality by Design and Lead Excellence in Kenya

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What Is Quality by Design and What Will You Gain?Build Quality in from the Design Stage

The Quality by Design Training (QbD) is a one-day, non-certification skills programme that teaches pharmaceutical teams how to build quality into a product from the design stage rather than testing it in at the end. Delivered across Kenya as instructor-led Quality by Design Training, it grounds every method in the ICH guidelines that the Pharmacy and Poisons Board and global authorities now expect.

QbD replaces trial-and-error development with a structured, science-based approach. You learn to define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), link them to material and process parameters through risk assessment, use Design of Experiments (DoE) to map the design space, and set a control strategy that holds production within it. The method is set out in ICH Q8(R2), Q9, Q10 and Q11 and is expected by regulators including the FDA and EMA.

For formulation, analytical, QC, process and regulatory professionals in Kenya's fast-growing pharmaceutical sector, these are the skills that turn local production into export-ready, submission-ready quality. Begin 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 Kenya 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 Kenya 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 Kenya

Instructor-led training formats available for individual learners and corporate teams across the Kenya
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 Kenya
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 Kenya 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 KenyaWho 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

What You Gain from QbD TrainingSkills You Can Apply from Day One

For Individuals

The Quality by Design Training helps pharmaceutical professionals build practical QbD capability they can apply immediately. It suits formulation, analytical, QC, process development, quality assurance and regulatory affairs specialists who want to move from trial-and-error development to a structured, science-based approach. Whether you are developing a new tablet, characterising a biologic, or preparing a dossier for the Pharmacy and Poisons Board, the tools you learn here connect directly to your day-to-day work.

If you want to lead QTPP definition, risk assessment, DoE and control strategy work in your organisation, this practical programme gives you the methods and the confidence to do it. You leave able to apply QbD on live development projects, with no exam required.

Build quality into products from the design stage instead of testing it in later
Apply the ICH Q8, Q9, Q10 and Q11 framework with practical confidence
Construct a QTPP and identify Critical Quality Attributes for real products
Lead risk assessments using Ishikawa diagrams and FMEA with RPN prioritisation
Plan and interpret Design of Experiments to define a robust design space
Develop control strategies and PAT plans that support consistent manufacturing
Strengthen ICH-aligned submissions and reduce post-approval changes
Add an in-demand, science-based capability valued across Kenya's pharma sector

For Organizations

Corporate Quality by Design Training equips your development and quality teams with a shared, science-based method for building quality into every product. It can be delivered for formulation groups, quality units, or cross-functional CMC teams at your site in Kenya or online. For manufacturers scaling local production and targeting export markets, QbD training turns individual expertise into a consistent organisational capability.

If your teams struggle with variable batches, inspection findings or slow submissions, group QbD training creates a common language across development, manufacturing and regulatory functions, and a repeatable approach to prioritisation, design space and control strategy.

Standardise QbD practice across formulation, quality and regulatory teams
Reduce batch failures, deviations and costly late-stage rework
Strengthen readiness for WHO and PPB GMP inspections
Improve the quality and speed of ICH-aligned regulatory submissions
Build in-house design space and control strategy capability
Support scale-up and technology transfer with real process understanding
Train cross-functional teams together on your own live projects
Choose flexible virtual, classroom and onsite delivery for your workforce

Where QbD Skills Take You in KenyaRoles, Sectors and Market Demand

Kenya is East Africa's most advanced pharmaceutical producer and one of the continent's largest drug exporters, with more than 37 licensed manufacturers. As the country pushes to raise local production, meet WHO and Pharmacy and Poisons Board GMP standards, and win export markets, employers need people who can build quality in by design, the practical capability that Quality by Design training develops. Demand is strongest in formulation, quality assurance, quality control, process development and regulatory affairs, and here is what the market shows.

37+

Licensed drug manufacturers in Kenya

industry and PPB, 2026

20-30%

Local share of medicine demand

Business Daily, 2026

~KSh 100bn

Annual pharmaceutical import bill

Business Daily, 2026

KSh 197k/mo

Pharma and biotech average pay

Salary Explorer (Kenya), 2026

SECTORS HIRING

—Pharmaceutical Manufacturing and Generics
—Biopharmaceuticals and Biotechnology
—Active Pharmaceutical Ingredient (API) Production
—Contract Development and Manufacturing (CDMOs)
—Regulatory Affairs and CMC Consulting
—Quality Assurance and Quality Control

GROWTH TRENDS

—National drive to raise local medicine manufacturing
—PPB GMP framework aligned to WHO standards
—ICH-aligned registration and submission requirements
—Universal Health Coverage expanding medicine demand
—Growing pharmaceutical export ambitions in the region
—Shortage of structured QbD and DoE capability

Sources: Business Daily, Kenya Ministry of Health, Pharmacy and Poisons Board, Salary Explorer, Paylab (Kenya) 2026.

Designation

Quality by Design Professionals in Kenya : Salary Insights and Trends

Hiring Companies in Kenya

KSh660K

Min

KSh1080K

Average

KSh1680K

Max

Paylab · PayScale (Kenya) 2026

Cosmos LimitedUniversal CorporationDawa LimitedBeta Healthcare

Source: Cosmos Limited · Universal Corporation · Dawa Limited · Beta Healthcare

Market Forces Driving Demand for QbD Skills in Kenya

The Local Manufacturing Gap

Local firms still supply only 20 to 30 percent of Kenya's medicines against a 50 percent national target, so manufacturers need robust, right-first-time development to scale up safely.

QbD helps teams scale output without quality slips

Heavy Reliance on Imported APIs

Most Kenyan makers depend on active ingredients imported from India and China. Understanding critical material attributes helps teams control incoming variability and protect product quality.

QbD builds critical material attribute control

Rising GMP and WHO Expectations

The Pharmacy and Poisons Board has aligned its GMP framework to WHO standards. QbD gives teams the process understanding that modern inspections and prequalification now require.

QbD delivers the process understanding inspections demand

ICH-Aligned Submissions

PPB registration guidance follows ICH requirements. Building QTPP, design space and control strategy evidence turns everyday development work into stronger, submission-ready dossiers.

QbD turns development work into stronger dossiers

Export Competitiveness

To compete regionally and reach stringent markets, Kenyan producers must prove consistent quality. Design-stage quality reduces batch failures and costly post-approval changes.

QbD reduces batch failures and post-approval changes

A Widening Skills Gap

Kenya's deep pharmacy talent pool is thin on structured QbD and DoE practice. Professionals who can lead risk assessment and design space work are increasingly sought after.

QbD makes structured practitioners stand out

Sources: Business Daily, Kenya Ministry of Health, Pharmacy and Poisons Board, WHO GMP guidelines (Kenya) 2026.

QbD is fast becoming the language of modern pharmaceutical quality. Build the skills Kenyan manufacturers and regulators now expect, and help your organisation produce quality by design. Start today.

Your Kenya QbD Transformation

Where Your Quality Practice Stands Today

The Shift QbD Delivers

Kenya's pharmaceutical sector is scaling up and raising its quality bar to meet WHO and PPB expectations. Employers increasingly separate teams that can design quality in from those that still test it in. Here is the shift this training delivers.

Today

Your value rests on general pharma experience shared by many peers

After Training

You hold in-demand QbD and DoE capability that Kenyan manufacturers actively seek

Today

Your value rests on general pharma experience shared by many peers

Today

You react to deviations and out-of-specification results after the fact

After Training

You build control strategies that keep production within a proven design space

Today

You react to deviations and out-of-specification results after the fact

Today

Regulatory feedback often means rework and delay

After Training

You prepare stronger, ICH-aligned submissions that move through review more smoothly

Today

Regulatory feedback often means rework and delay

You build QbD capability

Before

Quality is checked at the end through final testing, and failures are caught late

Now you have

Quality is designed in from the QTPP stage, so problems are prevented, not detected

Before

Quality is checked at the end through final testing, and failures are caught late

Before

Development runs on trial and error and one-factor-at-a-time testing

Now you have

You use structured DoE to map the design space and understand your process

Before

Development runs on trial and error and one-factor-at-a-time testing

Before

Risk is judged informally with little documented rationale

Now you have

You run Ishikawa and FMEA risk assessment that stands up to inspection

Before

Risk is judged informally with little documented rationale

Before

Submissions rely on empirical specifications alone

Now you have

You present QTPP, design space and control strategy evidence in ICH-aligned dossiers

Before

Submissions rely on empirical specifications alone

"The gap between testing quality in and designing it in is now what separates strong pharmaceutical teams, and the manufacturers that matter already know it."

Join professionals who trained with Invensis Learning and made the shift to Quality by Design.

Sources: Business Daily, Pharmacy and Poisons Board, WHO GMP guidelines (Kenya) 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 Kenya 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

The QbD Skills You Will BuildTools You Will Apply at Work

In this Quality by Design Training you will learn to apply the full QbD toolkit, from QTPP and CQA identification through risk assessment, DoE and the design space to PAT and the control strategy. Every tool is practised on realistic pharmaceutical development scenarios so you can use it at work immediately.

Define the Quality Target Product Profile

Translate patient and clinical needs into a QTPP that sets the design targets for the whole development programme and anchors every later QbD decision.

Identify Critical Quality Attributes

Determine which physical, chemical and biological attributes are critical to safety and efficacy, and classify them with confidence for small molecules and biologics.

Run Risk Assessment with Ishikawa and FMEA

Map material and process risks to each CQA, then prioritise them by severity, occurrence and detectability using RPN scoring to focus your development effort.

Design Experiments and Map the Design Space

Plan screening and response-surface DoE studies, interpret the models, and define the design space with Normal Operating Ranges and Proven Acceptable Ranges.

Apply Process Analytical Technology

Use PAT tools such as NIR and Raman to monitor critical attributes in real time and support real-time release testing during manufacturing.

Build a Robust Control Strategy

Turn risk and DoE findings into a control strategy of material, process and in-process controls, ready to present in ICH-aligned regulatory submissions.

Who Should TakeQuality by Design Training in Kenya?

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

KES 44850

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

Untitled

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 KenyaPractical, Expert-Led Learning

Invensis Learning delivers practical Quality by Design Training for pharmaceutical professionals and organisations across Kenya. Our programmes combine experienced trainers, hands-on QbD tool exercises, and content grounded in the ICH Q8 to Q11 framework, so learning connects directly to real development and manufacturing work. As a trusted Quality by Design training company in Kenya, Invensis Learning supports professionals and organisations alike. Whether you enrol as an individual or arrange corporate training for your team, you gain a professional learning experience built around practical understanding, real-world application and measurable outcomes.

ISO 9001:2015 certified training provider with rigorous quality management
ISO 27001:2022 certified for information security you can trust
Experienced trainers with real pharmaceutical and quality management expertise
Live virtual, classroom and onsite delivery to suit teams across Kenya
Practical, exercise-led sessions using realistic development scenarios
Content grounded in the ICH Q8 to Q11 QbD framework
Dedicated learner support before, during and after the training
Scalable corporate delivery for local and regional pharmaceutical teams

Flexible Learning Modes

98%

First-Attempt Pass Rate

5000+

Accredited Trainers Globally

4.7/5

Rated by Learners Worldwide

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 KenyaAll our classroom training is now available online at your convenience

Quality by Design in Kenya

Villa Rosa Kempinski, Waiyaki Way, Highridge sublocation, Highridge location, Highridge division, Westlands, Nairobi, Zimmerman, Soko ya Mawe, Nairobi, 97104, Kenya

Quality by Design in Kenya

Radisson Blu Hotel & Residence, Nairobi Arboretum, Aboretum Drive, Kilimani location, Kilimani ward, Kilimani division, Westlands, Nairobi, Zimmerman, Soko ya Mawe, Nairobi, 00400, Kenya

Quality by Design in Kenya

Villa Rosa Kempinski, Waiyaki Way, Highridge sublocation, Highridge location, Highridge division, Westlands, Nairobi, Zimmerman, Soko ya Mawe, Nairobi, 97104, Kenya

Quality by Design in Kenya

Radisson Blu Hotel & Residence, Nairobi Arboretum, Aboretum Drive, Kilimani location, Kilimani ward, Kilimani division, Westlands, Nairobi, Zimmerman, Soko ya Mawe, Nairobi, 00400, Kenya

Onsite QbD Training for TeamsBuilt for Kenya's Pharma

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Tailored QbD training for your formulation, quality and regulatory teams
Onsite, live virtual or blended delivery to fit your schedule
Sessions built around your own live development projects
Experienced trainers with pharmaceutical quality expertise
Consistent QbD practice across sites and business units
Progress tracking and dedicated coordination for group training
Scalable delivery for teams across Kenya and the region

What Our Learners Say

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From Trial and Error to a Structured Method

"The QbD training finally connected the ICH guidelines to what I do at the bench. I now build a QTPP and run risk assessment before touching a formulation, and my development work is far more structured."

Wanjiru Kamau

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DoE Made Practical and Clear

"The sessions on DoE and the design space were the most useful training I have done. I can now plan a screening study and read the model instead of testing one factor at a time. Very practical and hands-on."

Brian Otieno

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Stronger, Submission-Ready Dossiers

"As a regulatory professional, learning to structure QTPP, design space and control strategy evidence has made our submission dossiers noticeably stronger. The ICH context was explained clearly throughout."

Achieng Odhiambo

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A Shared QbD Language for Our Teams

"We ran the training onsite for our development and quality teams and it gave everyone a shared QbD language. Risk assessment and control strategy discussions are now much sharper across the site."

Daniel Mwangi

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Tailored, Practical Corporate Training

"Invensis Learning tailored the programme to our live projects and delivery schedule. The trainers understood pharmaceutical quality deeply, and our team left able to apply QbD tools straight away."

Grace Wambui

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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 is a systematic, science-based approach to pharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It is defined by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and uses tools such as the QTPP, CQAs, risk assessment, DoE and the control strategy.

General

What is Quality by Design (QbD)?

Who should attend the Quality by Design Training in Kenya?

The training suits formulation scientists, analytical and QC scientists, process development engineers, quality assurance professionals and regulatory affairs specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations across Kenya who want to apply QbD in product development and submissions.

Is the Quality by Design Training worth it?

Yes. QbD is increasingly expected by the Pharmacy and Poisons Board, WHO and stringent regulators, so the ability to build quality in is a valued, in-demand skill in Kenya's growing pharmaceutical sector. You gain practical tools you can apply to live development projects immediately, with no exam required.

Do I need prior QbD knowledge to attend?

No. The course has no formal prerequisites and introduces QbD from first principles. Familiarity with pharmaceutical development or GMP is helpful but not required, making it suitable for professionals across development, quality and regulatory functions.

Which standards does the training follow?

The training is grounded in the ICH quality guidelines: ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. These are the guidelines that define QbD and underpin modern regulatory submissions.

Pricing

How much does the Quality by Design Training cost in Kenya?

Fees vary by delivery format (live virtual, classroom or corporate onsite), group size and schedule, so pricing is available on request. Contact a learning advisor for a quote tailored to individual or team training in Kenya.

What is included in the course fee?

The fee typically covers instructor-led training across all six QbD modules, hands-on tool exercises, course materials and a course completion record from Invensis Learning. Request a quote to confirm exactly what is included in your chosen format.

Do you offer corporate or group pricing?

Yes. We offer corporate group training with tailored schedules and volume-based pricing for pharmaceutical teams. It is ideal for training a cross-functional development team together on your own projects. Ask a learning advisor about group pricing.

Are there tailored rates for teams in Kenya?

Group and corporate rates are available for teams, and pricing depends on team size and delivery mode. Talk to a learning advisor for a tailored group quote for your organisation.

How do I pay for the training?

We accept major cards and bank transfers, and corporate invoicing is available for organisations. Speak with a learning advisor to arrange the payment option that suits you.

Assessment

Is there an exam for the Quality by Design Training?

No. This is a non-certification skills course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and discussion, so you leave able to apply the methods rather than sit a test.

Do I receive a certificate after the training?

You receive a course completion record from Invensis Learning after completing the one-day programme. No formal credential is awarded by an external body, because QbD training is a practical skills course rather than a certification scheme.

How is learning assessed?

Learning is reinforced through practical exercises rather than a formal assessment. You practise QTPP construction, CQA identification, Ishikawa and FMEA risk assessment, and design space interpretation on realistic scenarios throughout the day.

Is QbD a certification?

No. Quality by Design is a methodology, not a certification. This course builds the practical skills to apply QbD; it does not lead to an exam or an accredited credential, so you can focus entirely on capability you can use at work.

Will this help with regulatory submissions?

Yes. You learn to structure QbD evidence (the QTPP, CQAs, risk assessment, design space and control strategy) in the ICH-aligned format that regulators such as the Pharmacy and Poisons Board expect in development and CMC submissions.

Course Content

What will I learn in the Quality by Design Training?

You will learn to apply the full QbD toolkit: defining the QTPP, identifying Critical Quality Attributes, running risk assessment with Ishikawa and FMEA, designing and interpreting DoE studies, defining the design space, using PAT, and building a control strategy for ICH-aligned submissions.

How long is the course?

The programme runs for one day (8 hours), and is also available as two half-days totalling 8 hours. It covers all six QbD modules with concept explanation, regulatory context and hands-on tool exercises using realistic pharmaceutical development scenarios.

Does it cover both small molecules and biologics?

Yes. The training covers QbD for both small molecule drug products such as tablets and injectables and biopharmaceuticals such as monoclonal antibodies, with case study examples from both to show how the tools apply across product types.

Are DoE and the design space covered practically?

Yes. You work through DoE design selection, model interpretation and design space definition, including Normal Operating Ranges and Proven Acceptable Ranges, using realistic scenarios so you can plan and read DoE studies at work.

What materials are provided?

You receive structured course materials and work through hands-on exercises covering QTPP construction, CQA and criticality assessment, risk assessment and design space interpretation, all applied to realistic pharmaceutical development cases.

Enrollment

How do I enrol in the Quality by Design Training in Kenya?

You can enrol through the Invensis Learning website or by contacting a learning advisor. Choose your preferred format, complete registration, and you receive schedule details and course materials ahead of the session.

What delivery formats are available?

The course is available as live virtual (online) instructor-led training, classroom training, and corporate onsite delivery for teams. Choose the format that best fits your schedule and learning preference in Kenya.

Can the course be delivered onsite for our team?

Yes. We deliver corporate onsite and live virtual QbD training for pharmaceutical teams across Kenya, and sessions can be built around your own live development projects. Contact us to arrange team training.

How soon can I start?

Public and corporate sessions run on a regular schedule. Contact a learning advisor to see upcoming dates and reserve a place for yourself or your team.

What is the reschedule policy?

Flexible options let you reschedule to another session where needed. Reach out to our support team to discuss the arrangements that apply to your enrolment.