Quality by Design Training in South Africa

Build Quality into Every Product

Master the Quality by Design approach used across South Africa's pharmaceutical and biopharmaceutical sector. This instructor-led programme equips formulation, process, quality and regulatory professionals to build quality into products from the design stage, applying the ICH Q8, Q9, Q10 and Q11 framework that SAHPRA now upholds as an ICH member.

Flexible

Duration

Live

Mode

Hours

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Master Quality by Design and Lead Excellence in South Africa

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ZAR 5690

What Quality by Design Training in South Africa CoversBuilding Quality in from the Design Stage

Quality by Design Training in South Africa gives pharmaceutical professionals a systematic, science-based way to build quality into a product from the design stage rather than testing it in at the end. The Quality by Design (QbD) approach is defined by the ICH Q8(R2) guideline and applied through Q9, Q10 and Q11, and it is the foundation of modern pharmaceutical development and regulatory submissions.

The programme suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and CMC regulatory specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations. You learn to construct a Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run risk assessments, plan Design of Experiments (DoE), define a design space and build a control strategy.

This matters more than ever in South Africa. With SAHPRA now an ICH member and local manufacturing expanding ahead of the 2026 patent cliff, regulators and employers increasingly expect QbD evidence in submissions. Start building that capability with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the South Africa 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 South Africa 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 South Africa

Instructor-led training formats available for individual learners and corporate teams across the South Africa
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 South Africa
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 South Africa 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 South AfricaWho 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 That Build Quality In

For Individuals

Quality by Design training helps pharmaceutical professionals replace empirical trial and error with a systematic, science-based way of developing products. You learn to design quality in from the outset and to defend that thinking in development reports and submissions. Whether you work in formulation, process development, analytical science, quality assurance or CMC regulatory affairs, the programme builds capability you can apply to live projects the day you return to work.

If you want to lead QbD on a product rather than support it, this training gives you the tools and the confidence to do so. You leave able to construct a QTPP, facilitate CQA and risk workshops, plan a DoE strategy and shape a control strategy that regulators recognise.

Apply the QbD approach to real pharmaceutical product and process development
Construct a Quality Target Product Profile and identify Critical Quality Attributes
Run structured risk assessments using FMEA and Ishikawa diagrams
Plan and interpret Design of Experiments to define a robust design space
Develop a control strategy and Process Analytical Technology plan
Structure QbD evidence for CTD submissions aligned to ICH Q8 to Q11
Move your team from quality-by-testing to designing quality in
Gain skills that transfer across pharma, biopharma, API and CDMO roles

For Organizations

QbD group training helps pharmaceutical organisations build development capability by equipping cross-functional teams with a shared, structured approach. The training can be delivered for R&D groups, quality teams, technical transfer teams or a whole product development function. For organisations scaling local manufacturing and complex biosimilars, this training turns QbD from a compliance phrase into a working practice.

If your teams still test quality in at the end, group QbD training creates a common way to design it in from the start. Cross-functional teams gain a standardised approach to QTPP, risk assessment, design space and control strategy that holds up under regulatory review.

Builds a shared QbD language across formulation, process, quality and regulatory teams
Reduces manufacturing deviations and batch failures through process understanding
Strengthens submission quality as SAHPRA aligns to ICH expectations
Speeds reliable scale-up of generics and biosimilars for local manufacturing
Enables customised delivery aligned to your live development projects
Standardises risk assessment and design space practice across sites
Provides flexible online, classroom and onsite delivery for teams
Builds in-house QbD capability instead of relying on external consultants

Where QbD Skills Lead in South AfricaTop Roles and Hiring Sectors

Quality by Design expertise is increasingly sought across South Africa's pharmaceutical and biopharmaceutical sector, where formulation scientists, process development engineers, quality assurance professionals and CMC regulatory specialists apply QbD to develop and manufacture medicines. With SAHPRA now an ICH member and local manufacturing expanding ahead of the 2026 patent cliff, professionals who can build quality into products from the design stage are in demand. Here is what the market is showing.

R637,000

Average formulation scientist salary, South Africa

per year, SalaryExpert 2026

R950,000

Regulatory affairs manager salary, South Africa

average, PayScale and SalaryExpert 2026

Since 2025

SAHPRA ICH membership

aligning submissions to ICH standards

18 sites

Aspen manufacturing footprint

Africa's largest pharma producer

SECTORS HIRING

—Pharmaceutical Manufacturing and Generics
—Biopharmaceuticals and Vaccines
—Active Pharmaceutical Ingredient (API) Production
—Contract Development and Manufacturing (CDMOs)
—Regulatory Affairs and CMC Consulting
—Medical Devices and Diagnostics

GROWTH TRENDS

—SAHPRA elevated to ICH membership in late 2025
—2026 patent cliff opening generics and biosimilar production
—Government drive to expand local manufacturing and cut imports
—QbD and continuous manufacturing adoption on the rise
—Growing oncology and immunology biosimilar demand
—Export ambitions across Africa raising quality expectations

Sources: SalaryExpert, PayScale, ERI (South Africa) 2026; DrugPatentWatch, SAHPRA, Arizton pharmaceutical market data 2025-2026.

Designation

Quality by Design Professionals in South Africa : Salary Insights and Trends

Hiring Companies in South Africa

R330K

Min

R480K

Average

R680K

Max

SalaryExpert, PayScale (South Africa) 2026

Aspen PharmacareAdcock IngramCipla

Source: Aspen Pharmacare Adcock Ingram Cipla

What Is Driving Demand for QbD Skills in South Africa

Local Manufacturing Push

South Africa is expanding local production to cut import reliance, and QbD provides the process understanding needed to develop and scale consistent, high-quality medicines at home.

QbD builds the process understanding to scale reliably

The 2026 Patent Cliff

As blockbuster patents expire, local producers race to launch generics and biosimilars. QbD design space and control strategy make consistent scale-up and reliable transfer possible.

QbD builds design space and control strategy skills

SAHPRA Now an ICH Member

SAHPRA's 2025 ICH membership raises expectations for QbD evidence in submissions, so development and CMC teams now need fluency in the Q8, Q9, Q10 and Q11 guidelines.

QbD builds ICH Q8 to Q11 fluency

Complex Biosimilar Development

Oncology and immunology biosimilars demand tight control of attributes like glycosylation and aggregation, exactly what QbD risk assessment, DoE and control strategy are built to manage.

QbD builds CQA and risk assessment skills

The Quality-By-Testing Legacy

Many sites still verify quality through end-product testing. QbD shifts development to designing quality in from the start, cutting deviations, rework and out-of-specification batches.

QbD shifts teams from testing to designing quality in

Scarce QbD Talent

South Africa has deep GMP and QC experience but few practitioners fluent in QTPP, design space and control strategy, making professionals who apply QbD tools genuinely valuable.

QbD training makes practitioners stand out

Sources: DrugPatentWatch, Arizton, IndexBox (South Africa pharma market) 2025-2026; SAHPRA ICH membership.

QbD is more than a compliance phrase. It is the practical skill South Africa's pharma sector needs to develop and scale medicines reliably. Join professionals who design quality in from the start. Begin your QbD journey today.

Your South Africa QbD Transformation

From Testing Quality in to Designing It In

Your QbD Transformation

South Africa's pharmaceutical sector is scaling local manufacturing and adopting Quality by Design ahead of the 2026 patent cliff, and employers increasingly separate professionals who can design quality in from those who only test it. Here is which side of that line you want to be on.

Today

Seen as a capable QC or formulation contributor

After QbD

Recognised as the person who can lead QbD on a product, not just support it

Today

Seen as a capable QC or formulation contributor

Today

Limited to your own function on development projects

After QbD

Able to connect formulation, process, quality and regulatory work into one approach

Today

Limited to your own function on development projects

Today

Skills tied to one employer's way of working

After QbD

Fluent in an internationally harmonised approach that travels across sectors and sites

Today

Skills tied to one employer's way of working

You master QbD

Before

Quality is verified by end-product testing, with deviations found late

Now you have

Quality is designed in from the start using a QTPP and defined CQAs

Before

Quality is verified by end-product testing, with deviations found late

Before

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

Now you have

You use Design of Experiments to understand relationships and set the design space

Before

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

Before

Risk is judged informally, without a structured method

Now you have

You run FMEA and Ishikawa risk assessments to prioritise CPPs and CMAs

Before

Risk is judged informally, without a structured method

Before

Submissions lack the process understanding regulators now expect

Now you have

You structure QbD evidence aligned to ICH Q8 to Q11 for SAHPRA and beyond

Before

Submissions lack the process understanding regulators now expect

"The gap between testing quality in and designing it in is exactly what South Africa's pharma sector is now hiring for."

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

Sources: SalaryExpert, PayScale (South Africa) 2026; SAHPRA, DrugPatentWatch 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 South Africa 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 Tools You Will MasterQTPP, DoE and Control Strategy

This training builds the practical skills to apply Quality by Design across pharmaceutical product and process development. By the end, you can construct a QTPP, identify CQAs, run risk assessments, plan DoE, define a design space, apply PAT and build a control strategy for regulatory submission.

Quality Target Product Profile (QTPP)

Build a QTPP that defines what a product must achieve for quality, safety and efficacy, from dosage form and route of administration to the pharmacokinetic target and container closure system. This becomes the design specification for the whole QbD programme.

Critical Quality Attributes (CQAs)

Identify and classify the physical, chemical, biological and microbiological attributes critical to product quality, and link each CQA to Critical Material Attributes and Critical Process Parameters using prior knowledge and structured assessment.

Risk Assessment with FMEA and Ishikawa

Run structured risk assessments to prioritise which material attributes and process parameters most affect the CQAs. Apply Ishikawa diagrams and FMEA with Risk Priority Numbers to focus experimental effort where it matters most.

Design of Experiments and Design Space

Use DoE to quantify how CPPs and CMAs affect CQAs and to define the design space, Normal Operating Ranges and Proven Acceptable Ranges. Understand screening, response surface and mixture designs and how to read the model output.

Process Analytical Technology (PAT)

Apply PAT tools such as NIR and Raman spectroscopy for real-time monitoring of critical attributes during manufacturing, and understand how PAT supports real-time release testing within a QbD control approach.

Control Strategy and Regulatory Submission

Develop a control strategy from your risk assessment and DoE outputs, and structure the QbD evidence for CTD Section 3.2.P.2 submissions aligned to ICH Q8 to Q11 and the expectations of authorities such as SAHPRA.

Who Should TakeQuality by Design Training in South Africa?

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

ZAR 5690

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 Train with Invensis LearningFor QbD Training in South Africa

As a trusted Quality by Design training company, Invensis Learning delivers practical training for pharmaceutical professionals and organisations across South Africa and worldwide. Our programmes combine experienced trainers, structured courseware aligned to the ICH guidelines, hands-on tool exercises and flexible delivery. Whether you enrol as an individual or arrange online (live virtual) training for your team, you learn from experts and apply QbD to real development scenarios, backed by ISO 9001:2015 and ISO 27001:2022 certified processes and dependable learner support.

Globally experienced trainers with real pharmaceutical and quality management expertise
Online (live virtual), classroom and onsite delivery to fit your schedule
Structured, practical courseware built around the ICH Q8 to Q11 guidelines
Hands-on QbD tool exercises using realistic pharmaceutical development scenarios
ISO 9001:2015 quality and ISO 27001:2022 information security certified operations
Dedicated learner support before, during and after the training
Customised corporate delivery for pharmaceutical and biopharmaceutical teams
Course completion certificate on finishing the programme

60+

Global Course Portfolio

100+

Countries Served

ISO 9001

Quality Management

200K+

Professionals Trained

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 South AfricaAll our classroom training is now available online at your convenience

Quality by Design in South Africa

The Westin Cape Town Convention Square, Lower Long Street, Cape Town Ward 115, Cape Town, City of Cape Town, Western Cape, 8000, South Africa

Quality by Design in South Africa

Southern Sun Katherine Street Sandton, 115, Linden Street, Atholl Gardens, Johannesburg Ward 91, Johannesburg, City of Johannesburg Metropolitan Municipality, Gauteng, 2146, South Africa

Quality by Design in South Africa

The Westin Cape Town Convention Square, Lower Long Street, Cape Town Ward 115, Cape Town, City of Cape Town, Western Cape, 8000, South Africa

Quality by Design in South Africa

Southern Sun Katherine Street Sandton, 115, Linden Street, Atholl Gardens, Johannesburg Ward 91, Johannesburg, City of Johannesburg Metropolitan Municipality, Gauteng, 2146, South Africa

Corporate QbD Training for Pharma TeamsIn South Africa

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Suitable for R&D, quality, process and regulatory teams of any size
Customised schedules aligned to your team's availability
Flexible delivery through onsite, live virtual or hybrid formats
Trainers with real pharmaceutical development and QbD expertise
Exercises applied to your own live product development projects
Dedicated coordination and support for group programmes
Scalable delivery for teams across South Africa and beyond

What Our Learners Say

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From Trial and Error to a Real Design Space

"The training finally connected the QbD tools for me. I can now build a QTPP, run a proper risk assessment and plan a DoE instead of testing one factor at a time. I applied it to a tablet reformulation the week I returned to work."

Thandiwe Mokoena

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DoE That Made Scale-Up Predictable

"The Design of Experiments and design space sessions were exactly what I needed for scale-up. Understanding Normal Operating Ranges and Proven Acceptable Ranges has already made our transfers far more predictable."

Riaan Botha

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Made QbD Submissions Make Sense

"As a regulatory professional I needed to understand how QbD evidence fits the CTD. The control strategy and Section 3.2.P.2 walkthrough was practical and directly relevant now that SAHPRA aligns to ICH."

Naledi Dlamini

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A Shared QbD Language Across Our Teams

"We ran this as an onsite programme for our development and quality teams. It gave everyone a shared QbD language, and the exercises used our own products. Deviations discussions are far more structured now."

Sipho Naidoo

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Tailored to Our Biosimilar Pipeline

"Invensis Learning tailored the sessions to our biosimilar pipeline. Our scientists now apply CQA identification and risk assessment consistently, which was exactly the capability gap we set out to close."

Michelle van der Merwe

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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 programme that teaches the QbD approach to pharmaceutical product and process development. You learn to build quality into a product from the design stage using the ICH Q8, Q9, Q10 and Q11 framework, rather than testing it in at the end.

General

What is Quality by Design (QbD) training?

Who should attend QbD training in South Africa?

The training suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals, CMC regulatory specialists and manufacturing technical managers in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations across South Africa.

Is Quality by Design training worth it?

Yes. QbD is expected by regulators such as SAHPRA, now an ICH member, and underpins reliable local manufacturing of generics and biosimilars. Professionals who can design quality in from the start are in demand across South Africa's pharmaceutical sector.

Is QbD relevant to both small molecule and biologic products?

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

Which ICH guidelines does the training cover?

The training is grounded in ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, with links to PAT and ICH Q12 lifecycle management.

Pricing

How much does QbD training cost in South Africa?

Fees vary by delivery mode, group size and format, and local training is quoted in South African rand. Pricing is available on request. Speak with a learning advisor for a quote tailored to individual or team enrolment.

What is included in the QbD course fee?

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

Do you offer group or corporate rates for QbD training?

Yes. We offer corporate group training with customised schedules and pricing for pharmaceutical R&D, quality and regulatory teams. Contact us for a group quote based on your team size and delivery preference.

What payment options are available?

We accept major cards and bank transfers, and corporate invoicing is available for group bookings. Talk to a learning advisor to choose the option that suits you.

Is the training a good investment for a whole team?

Group training is often the most cost-effective route, as it gives a whole development or quality team one shared QbD approach and lets exercises use your own products. Ask about group pricing for your organisation.

Assessment

Is there an exam or assessment for this training?

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

Will I get proof of completion after the training?

Yes. You receive a course completion certificate from Invensis Learning. It confirms you have completed the programme; it is not a formal certification, as QbD training has no external awarding body or exam.

Are there any prerequisites for the training?

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.

Will I be able to apply QbD at work straight away?

Yes. The skills are immediately usable. After the training you can construct a QTPP, lead CQA and risk workshops, plan and interpret DoE, define a design space and shape a control strategy for real projects.

How is learning reinforced without an exam?

Through practical work. You complete QbD tool exercises, such as building a QTPP, identifying CQAs, drawing an Ishikawa diagram and interpreting a design space, using realistic pharmaceutical development scenarios during the session.

Course Content

What topics does the QbD training cover?

The programme covers QbD principles and the ICH framework, the QTPP and CQAs, risk assessment, Design of Experiments and the design space, Process Analytical Technology and the control strategy, plus QbD in practice through case studies and submissions.

What QbD tools will I learn to use?

You learn to apply the QTPP, CQA identification, Ishikawa diagrams and FMEA for risk assessment, DoE for the design space, Normal Operating and Proven Acceptable Ranges, PAT tools and the control strategy.

Are there hands-on exercises in the training?

Yes. Hands-on QbD tool exercises run throughout, including QTPP construction, CQA identification and criticality assessment, Ishikawa risk mapping, DoE design selection and design space interpretation using realistic development scenarios.

How long is the QbD training?

The programme runs for one day, a total of eight hours, covering all six QbD modules with concept explanations, the ICH regulatory context, case study examples and hands-on tool exercises.

Is the courseware aligned to the current ICH guidelines?

Yes. The courseware is aligned to the current ICH Q8(R2), Q9, Q10 and Q11 guidelines that define QbD, and reflects how authorities such as SAHPRA now expect QbD evidence in submissions.

Enrollment

How do I enrol in QbD training in South Africa?

Enrol through the Invensis Learning website or contact our team. Choose your preferred format, complete your booking, and you receive access to schedules, courseware and learning resources. See upcoming batches to get started.

What training formats are available?

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

Can the training be delivered onsite for my team?

Yes. We deliver onsite and live virtual group training for pharmaceutical organisations, and exercises can use your own live development projects. Contact us to arrange a session for your team in South Africa.

How soon can I start the QbD training?

Public sessions run on a regular schedule, and corporate onsite dates are arranged to suit your team. Speak with a learning advisor to see upcoming batches and find the earliest date that works for you.

What is the reschedule or cancellation policy?

Rescheduling and cancellations are handled under our published policy, and flexible options are available on selected bookings. Reach out to our team for the details that apply to your enrolment.