Quality by Design Training in Malawi

Build Quality into Every Product

Designed for pharmaceutical and biopharma professionals in Malawi, this instructor-led programme from a leading Quality by Design training company shows you how to design quality into products from the start using the ICH Q8, Q9, Q10 and Q11 framework. Build job-ready skills in QTPP, critical quality attributes, risk assessment, design of experiments and the control strategy that regulators such as the FDA and EMA now expect.

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What Is Quality by Design and Why It Matters in MalawiA Science-Led Route to Better Medicines

Quality by Design (QbD) Training in Malawi is a practical, non-certification programme that teaches a systematic, science-based approach to building quality into pharmaceutical and biopharmaceutical products from the design stage, rather than inspecting for it after manufacture. The training is grounded in the ICH guidelines, primarily ICH Q8(R2) Pharmaceutical Development, supported by ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances.

Over one focused day you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. These are the same expectations that regulators such as the FDA and EMA now build into modern development and manufacturing submissions.

For formulation scientists, analytical chemists, process engineers, QA staff and regulatory affairs professionals across Malawi's growing pharmaceutical sector, this is a direct way to strengthen local quality practice and support WHO-GMP ambitions. Start your QbD journey with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Malawi 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 Malawi 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 Malawi

Instructor-led training formats available for individual learners and corporate teams across the Malawi
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 Malawi
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 Malawi 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 MalawiWho 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 Quality by Design Skills Are Worth ItValue You Apply on the Job

For Individuals

QbD training helps pharmaceutical professionals in Malawi build practical capability they can use the next day at work. You learn to define what a product must achieve, identify what is critical to its quality, and control the process that delivers it. Whether you work in formulation, analytical development, process engineering, quality assurance or regulatory affairs, the training gives you a shared, science-based language for building quality in by design.

If you want to raise the standard of local development and manufacturing and strengthen your own profile, QbD is a clear step forward. You gain hands-on tool experience, real case examples and a structured method you can lead with in your own organisation.

Design quality into products from the start instead of relying on end-product testing
Apply the full QbD toolkit: QTPP, CQAs, risk assessment, DoE, design space and control strategy
Strengthen your value to pharmaceutical, biopharma, API and CDMO employers across Malawi and the region
Support WHO-GMP compliance and cut costly manufacturing deviations and rework
Prepare stronger regulatory submissions aligned to ICH Q8, Q9, Q10 and Q11
Move from trial-and-error development to a mechanistic, science-based approach
Build cross-functional confidence across formulation, analytical, process and QA teams
Earn a course completion record from Invensis Learning you can apply immediately

For Organizations

QbD group training helps pharmaceutical organisations in Malawi build quality capability across a whole development team at once. The training can be delivered for QA departments, formulation and process groups, or cross-functional project teams. For manufacturers working to meet WHO-GMP expectations and compete regionally, this training gives teams a scalable, practical method for building quality into products from the outset.

If your organisation relies on end-product testing and trial-and-error development, QbD training creates a shared, structured approach to quality. Teams learn to apply QTPP, risk assessment, DoE and control strategy to their own products, strengthening both compliance and consistency.

Builds a consistent, science-based quality approach across development teams
Reduces batch failures, deviations and rework by designing quality in early
Strengthens WHO-GMP readiness and the quality of regulatory submissions
Creates a shared QbD language across formulation, QA, process and regulatory staff
Enables customised training aligned to your own live product development work
Supports market access into the wider SADC region with GMP-grade practice
Provides flexible onsite, live virtual and blended delivery for teams
Builds stronger in-house quality and process-understanding capability

Career Payoff of QbD Skills in MalawiRoles and Demand Across Pharma

Quality by Design capability is becoming a genuine differentiator in Malawi's pharmaceutical sector. As the Pharmacy and Medicines Regulatory Authority pushes local plants towards WHO-GMP standards and the country works to close a well-documented quality gap in locally made medicines, employers increasingly value professionals who have completed Quality by Design training and can build quality in by design. Roles span QA and QC officers, formulation and process scientists, regulatory affairs specialists and quality managers, and here is what the local market is signalling.

MWK 4.2M

Average pharmacist pay, Malawi

per year, Paylab 2026

4.4%

Africa generic medicines growth

CAGR, Grand View Research

30%

Local-made medicines flagged substandard

PLOS One Malawi study

Pharmaceutical manufacturers in Malawi

industry data, 2026

Sectors Hiring QbD Skills

—Pharmaceutical Manufacturing and Formulation
—Generic and Essential Medicines Producers
—Regulatory Affairs and Quality Assurance
—Central Medical Stores and Public Health Supply
—Contract Manufacturing and API Suppliers
—Medical Devices and Veterinary Pharmaceuticals

Local Demand Drivers

—PMRA driving WHO-GMP compliance across local plants
—Local-manufacture quality gap creating demand for QbD skills
—SADC market access rewarding GMP-grade quality systems
—Africa generic-medicines segment growing around 4.4% a year
—Import-substitution push to strengthen local production
—Scarce pharmaceutical quality talent in the local market

Sources: PMRA, PLOS One (Malawi medicine quality study), Paylab and Africarrieres (Malawi salary guides), Grand View Research (Africa pharmaceuticals) 2024-2026.

Designation

Quality by Design Professionals in Malawi : Salary Insights and Trends

Hiring Companies in Malawi

MK2400K

Min

MK3300K

Average

MK4800K

Max

Paylab · Africarrieres (Malawi) 2026

Laboratory & AlliedPharmanovaKentam Products

Source: Laboratory & Allied · Pharmanova · Kentam Products

Market Pressures Making QbD Skills Valuable in Malawi

Local Manufacturing Quality Gap

Studies found around 30% of medicines made in Malawi were substandard or falsified, against 6.6% for imports. Building quality in by design is the systematic fix regulators want to see.

QbD builds designed-in quality skills

WHO-GMP Compliance Pressure

The PMRA is pushing local plants towards WHO-GMP standards, yet few facilities in the region fully meet them. QbD process understanding underpins the compliance regulators expect.

QbD builds process-understanding skills

Reliance on Imported Medicines

Malawi imports most of its medicines, straining foreign exchange. Stronger local quality practice is essential to build trustworthy domestic production and reduce that dependence.

QbD strengthens local production quality

Scarce Pharmaceutical Quality Talent

With only a handful of local manufacturers and thin technical talent, professionals who can run QTPP, risk assessment and DoE are rare and increasingly sought after.

QbD makes quality professionals stand out

SADC and Regional Market Access

Selling into the wider SADC market rewards GMP-grade quality systems. QbD gives Malawian producers the process understanding needed to compete beyond the border.

QbD builds GMP-grade quality systems

Costly Deviations and Rework

Trial-and-error development drives batch failures, deviations and rework that small manufacturers cannot afford. Designing quality in reduces these losses at the source.

QbD reduces batch failures at the source

Sources: PMRA, PLOS One (Malawi medicine quality study), UNIDO and SAGMA, Grand View Research 2024-2026.

QbD is more than a quality trend. It is a practical capability that helps Malawi's pharmaceutical sector build medicines the market can trust. Start building these skills today.

Your Malawi QbD Transformation

From Reactive Testing to Designed-In Quality

Where QbD Takes Your Practice

Malawi's pharmaceutical sector is under real pressure to lift quality and meet WHO-GMP expectations. Professionals who can design quality in, not just test for it, are the ones who move ahead. Here is the shift QbD training delivers.

Today

Quality problems are caught late, through end-product testing and rejected batches

After QbD

You identify and control critical quality attributes early, before they reach the patient

Today

Quality problems are caught late, through end-product testing and rejected batches

Today

Development runs on trial and error, with little mechanistic understanding

After QbD

You use risk assessment and DoE to understand and predict how the process affects quality

Today

Development runs on trial and error, with little mechanistic understanding

Today

Submissions are thin on process understanding and design justification

After QbD

You structure QTPP, design space and control-strategy evidence the way ICH Q8 expects

Today

Submissions are thin on process understanding and design justification

You build QbD capability

Before

Quality seen as a QC checkpoint at the end of the line

Now you have

A science-based approach that builds quality into every stage of development

Before

Quality seen as a QC checkpoint at the end of the line

Before

Limited standing when quality issues or deviations arise

Now you have

The tools and language to lead QbD conversations across formulation, QA and regulatory teams

Before

Limited standing when quality issues or deviations arise

Before

Skills tied to one plant, product or department

Now you have

Transferable capability valued across pharma, biopharma, API and CDMO employers

Before

Skills tied to one plant, product or department

Before

A career limited by a narrow, testing-focused role

Now you have

A clear route into formulation, process, regulatory and quality management roles

Before

A career limited by a narrow, testing-focused role

"In modern pharmaceutical development, the gap between testing quality in and designing it in is exactly what separates trusted manufacturers from the rest."

Join the professionals who built practical, workplace-ready skills with Invensis Learning.

Sources: PMRA, PLOS One, Paylab (Malawi) 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 Malawi 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 ProgrammeApplying the Core QbD Toolkit

By the end of this Quality by Design programme you will be able to apply the full QbD toolkit to real pharmaceutical development scenarios, from defining the target product profile through risk assessment and DoE to a documented, submission-ready control strategy.

Define the Quality Target Product Profile

Build a QTPP from clinical and patient needs, translating the desired quality, safety and efficacy of a product into a clear design specification that guides the whole development programme.

Identify Critical Quality Attributes

Determine which physical, chemical, biological and microbiological properties are critical to product quality, and link them to critical material attributes and critical process parameters.

Run Structured Risk Assessment

Use Ishikawa (fishbone) diagrams and FMEA with risk priority numbers to prioritise the material attributes and process parameters that most strongly influence product quality.

Apply DoE and the Design Space

Use Design of Experiments to understand how inputs affect quality, define the design space, and set normal operating ranges and proven acceptable ranges with confidence.

Build a Robust Control Strategy

Turn risk assessment and DoE outputs into a control strategy spanning material controls, process controls, in-process testing and Process Analytical Technology monitoring.

Present QbD in Regulatory Submissions

Structure QbD evidence for the CTD format, Section 3.2.P.2, connecting QTPP, design space and control strategy the way ICH Q8 and regulators such as the FDA and EMA expect.

Who Should TakeQuality by Design Training in Malawi?

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

USD 345

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 in MalawiTrusted, Practical and ISO-Certified

Invensis Learning is a global, ISO 9001:2015 certified training organisation and a trusted Quality by Design training company in Malawi that helps pharmaceutical and quality professionals build practical, workplace-ready capability. Our Quality by Design training is delivered by experienced practitioners and grounded in the ICH guidelines that shape modern pharmaceutical development. Whether you are an individual learner in Blantyre or Lilongwe or a manufacturer training a whole development team, we offer flexible formats, structured courseware and hands-on exercises focused on real application, not just theory.

ISO 9001:2015 certified training provider with ISO 27001:2022 information security
Experienced practitioner trainers in quality management and process improvement
Flexible delivery: live virtual (online), classroom and onsite corporate formats
QbD content aligned to the ICH Q8, Q9, Q10 and Q11 guidelines
Hands-on exercises using realistic pharmaceutical development scenarios
Dedicated learner support before, during and after the training
Global training partner with regional support across Malawi and Africa
Course completion record from Invensis Learning on finishing the programme

24/7

Learner Support

50+

Industries Served

1-to-1

Doubt-Clearing Sessions

60+

Global Course Portfolio

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 MalawiAll our classroom training is now available online at your convenience

Quality by Design in Malawi

President Walmont Hotel Lilongwe, Malawi

Quality by Design in Malawi

Sunbird Mount Soche Blantyre, Malawi

Quality by Design in Malawi

President Walmont Hotel Lilongwe, Malawi

Quality by Design in Malawi

Sunbird Mount Soche Blantyre, Malawi

Corporate Quality by Design TrainingUpskill Your Whole Team

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Tailored QbD training for formulation, QA, process and regulatory teams
Flexible onsite, live virtual, hybrid or blended delivery in Malawi
Schedules aligned to your production and project calendars
Real examples applied to your own live product development work
Experienced trainers with pharmaceutical quality expertise
Progress tracking and dedicated coordination for group training
Scalable delivery for teams across Malawi and the region

What Our Learners Say

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A Practical Shift in How I Develop Products

"The training finally gave me a structured way to move from end-product testing to building quality in. Working through the QTPP and CQA exercises on a real formulation changed how our whole development approach looks."

Chikondi Banda

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Clear Link Between Process and Quality

"The risk assessment and control strategy sessions were exactly what I needed. I now understand how our process parameters link to quality attributes, and I can explain it clearly to the production team during reviews."

Thandiwe Phiri

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The Regulatory Picture Finally Made Sense

"Grounding everything in ICH Q8 through Q11 made the regulatory side click for me. Structuring QbD evidence for a submission is far less daunting now, and the case examples were genuinely relevant to our work."

Blessings Mvula

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Great Team Upskilling on Quality

"We brought the training onsite for our quality and process teams and it gave everyone a shared QbD language. The design space and DoE exercises were hands-on and immediately useful for our current products."

Grace Chirwa

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Practical Capability Building for Our Team

"As a training sponsor, I wanted something practical that would raise our WHO-GMP readiness. The programme delivered. Our team now applies structured risk assessment and control strategy thinking to real development work."

Patrick Nkhoma

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4.6

Ratings

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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 building quality into pharmaceutical products from the design stage. It covers the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, risk assessment, DoE and the control strategy.

General

What is Quality by Design (QbD) training?

Is QbD training worth it for professionals in Malawi?

Yes. As the PMRA pushes local plants towards WHO-GMP standards and Malawi works to close its medicine-quality gap, employers increasingly value staff who can design quality in. The skills apply immediately across formulation, QA, process and regulatory roles.

Who should attend the QbD training?

The training suits formulation and analytical scientists, process development engineers, quality assurance staff, regulatory affairs professionals and manufacturing managers in pharmaceutical, biopharma, API, CDMO and medical device organisations.

Do I need prior experience to take the course?

No. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, 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 guidelines, primarily ICH Q8(R2) Pharmaceutical Development, with ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. It reflects expectations from regulators such as the FDA and EMA.

Pricing

How much does QbD training cost in Malawi?

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

What is included in the course fee?

The fee typically includes instructor-led training across all QbD modules, structured courseware, hands-on tool exercises, pharmaceutical case examples, learner support and a course completion record from Invensis Learning.

Do you offer group or corporate pricing?

Yes. We offer corporate group training with customised schedules and volume-based pricing for QA departments, development teams and cross-functional groups. Ask about corporate pricing for your team.

What payment options are available?

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

Can fees be quoted in Malawian Kwacha?

Corporate quotes for Malawian teams can be discussed in your local context, including Malawian Kwacha where applicable. Request a quote and an advisor will confirm the details for your chosen format.

Assessment

Is there an exam for the QbD training?

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

How is my learning assessed?

There is no formal assessment. Throughout the programme you apply QbD tools, such as QTPP construction, CQA identification, risk assessment and design space interpretation, to realistic development scenarios to reinforce learning.

What do I receive on completing the course?

You receive a course completion record from Invensis Learning. This is a skills training programme, so it is a record of completion rather than a formal certification, and there is no certifying body or credential exam involved.

Is there any renewal or expiry to worry about?

No. There is nothing to renew and no credential to maintain. The QbD knowledge and tools you gain are immediately applicable and do not expire.

Will this course make me QbD certified?

The course builds practical QbD skills and provides a course completion record from Invensis Learning. It is a skills training programme, not a formal certification, so it does not award an accredited credential.

Course Content

What topics does the QbD syllabus cover?

The syllabus covers QbD principles and the ICH regulatory context, QTPP and CQA identification, risk assessment with Ishikawa and FMEA, DoE and the design space, PAT and the control strategy, plus QbD case studies and regulatory submission.

What will I be able to do after the training?

You will be able to construct a QTPP, identify and classify CQAs, run a risk assessment, plan and interpret DoE, define a design space with NOR and PAR, build a control strategy, and structure QbD evidence for CTD submissions.

Does the course cover both small molecules and biologics?

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

Are there hands-on exercises in the course?

Yes. Hands-on QbD tool exercises run throughout the programme, covering QTPP construction, CQA identification, Ishikawa risk mapping, DoE design selection and design space interpretation, all applied to realistic pharmaceutical scenarios.

How long is the QbD training?

The programme is delivered as a focused one-day, eight-hour course covering all the QbD modules, from principles and the ICH framework through to the control strategy and regulatory submission.

Enrollment

How do I enrol in the QbD training?

You can enrol through the Invensis Learning website. Choose your preferred format, complete the booking, and you will receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need guidance.

What training formats are available?

We offer live virtual (online) instructor-led training, classroom training, and customised onsite corporate group training, so you can choose the format that best fits your schedule and team.

Can teams in Malawi be trained onsite?

Yes. We deliver onsite corporate training for teams in Malawi, which lets a whole development or quality group apply QbD tools to their own live products together. Ask about onsite delivery for your organisation.

How soon can I start?

New sessions run regularly in live virtual and classroom formats, and corporate sessions can be scheduled around your team's availability. See upcoming schedules or request a date that suits you.