Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Quality by Design Training in South Africa Covers

    Building Quality in from the Design Stage

    Quality by Design course badge

    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the South Africa

    Who Can Enrol?

    What You Gain from QbD Training

    Skills That Build Quality In

    Who Should Take Quality by Design Training in South Africa?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Lead in South Africa

    Top 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.

    What Is Driving Demand for QbD Skills in South Africa

    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.

    Sources: SalaryExpert, PayScale (South Africa) 2026; SAHPRA, DrugPatentWatch 2025-2026.

    Module 2: QbD Tools and Techniques

    • Risk management principles and tools used to identify, assess, and control quality risks in product development
    • Design of Experiments (DoE): fundamentals, design types, and how DoE is used to understand process variability
    • Design Space definition and control strategies: how boundaries are established and maintained throughout the product lifecycle

    Module 3: Industry and Regulatory Perspective

    • Regulatory framework for QbD including agency expectations from the FDA, EMA, and ICH guidelines
    • Implementation challenges organizations face when transitioning from traditional to QbD-based development approaches
    • Real-world industry examples demonstrating how pharmaceutical and biotechnology organizations have adopted QbD

    Module 4: Quality Target Product Profile (QTPP)

    • Definition of the Quality Target Product Profile and its role in guiding QbD-based product development decisions
    • How QTPP links patient needs and regulatory requirements to specific product quality attributes and design objectives
    • Practical steps for defining a QTPP for pharmaceutical and biotechnology products

    Module 5: Critical Quality Attributes, Critical Material Attributes, and Critical Process Parameters

    • Identifying Critical Quality Attributes (CQAs): what they are, how to define them, and why they are central to QbD
    • Critical Material Attributes (CMAs): how raw material properties influence product quality and must be controlled
    • Critical Process Parameters (CPPs): identifying process parameters that impact CQAs and require monitoring and control

    Module 6: Statistical Design of Experiments

    • Fundamentals of statistical DoE including full factorial, fractional factorial, and response surface methodologies
    • Applications of DoE in pharmaceutical process development and optimisation
    • Interpreting DoE results to establish design space boundaries and process understanding

    Module 7: Design Space and Process Control

    • Design Space concept: defining the multidimensional combination of input variables and process parameters that provide quality assurance
    • Implementation of Design Space within regulatory submissions and manufacturing control strategies
    • Continuous process verification and how Design Space supports process control across the product lifecycle

    Module 8: Risk Assessment and Management

    • Risk assessment methodologies used in QbD including FMEA, Ishikawa diagrams, and risk ranking tools
    • Applying risk management principles to product development decisions, process design, and control strategy development
    • Linking risk assessment outcomes to Design Space boundaries and CQA control strategies

    Module 9: Real-time Release Testing (RTRT)

    • RTRT concept: replacing end-product testing with in-process monitoring and real-time quality assurance
    • Regulatory requirements and industry expectations for RTRT implementation in pharmaceutical manufacturing
    • Practical considerations for implementing RTRT as part of a QbD-based control strategy

    Module 10: Case Studies and Practical Applications

    • Pharmaceutical and biotechnology case studies demonstrating end-to-end QbD implementation from QTPP to RTRT
    • Practical group exercises and scenario analysis applying QbD tools including QTPP definition, CQA identification, DoE, and risk assessment
    • Lessons learned and best practices from real QbD projects in pharmaceutical, biotechnology, and manufacturing environments

    Course Curriculum

    of the Quality by Design Training

    The online Quality by Design training course curriculum in the 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.

    image

    100% Secure and Safe download

    The QbD Tools You Will Master

    QTPP, 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.

    Quality by Design Training Modes

    for Professionals and Teams

    We offer flexible training formats designed to suit different learning preferences, schedules, and professional goals. Whether you prefer self-paced learning or a structured, corporate, instructor-led experience, choose the option that best supports your skill development journey with the best Quality by Design online training options.

    Quality by Design Classroom Training

    • Instructor-led classroom sessions

    • Interactive discussions and group activities

    • Real-world examples and practical exercises

    • Structured learning with fixed schedules

    • Opportunities for peer networking and collaboration

    • Practice assessments and knowledge checks

    • Dedicated Q&A and concept clarification

    • Immediate trainer feedback and support

    Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

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

    Quality by Design Corporate Group Training

    • Customised training aligned to organisational goals

    • Flexible delivery: onsite, virtual, hybrid, or blended

    • Scheduling tailored to business availability

    • Role-based examples and industry-relevant discussions

    • Progress tracking and learner assessments where applicable

    • Dedicated coordination and administrative support

    • Consistent learning experiences across teams

    • Scalable delivery for local, regional, or global workforces

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

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

    Quality by Design Focused 1-to-1 Training

    • One-to-one instructor attention

    • Customised learning plans and objectives

    • Flexible scheduling based on availability

    • Personalized feedback and coaching

    • Additional focus on challenging topics

    • Targeted practice and revision support

    • Faster clarification of questions and concepts

    • Learning pace is adapted to individual needs

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

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

    Quality by Design Live Virtual Training

    Quality by Design Live Virtual Training

    Live online instructor-led sessions

    Interactive discussions and virtual activities

    Expert guidance from experienced trainers

    Practice assessments and revision support

    Dedicated Q&A sessions for concept clarification

    Fixed schedules for accountability and momentum

    Small batch sizes for personalized attention

    Access from any location with internet connectivity

    Starts from

    ZAR 5360

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

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

    Loading schedules…

    Why Train with Invensis Learning

    For 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 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

    Quality by Design Training Locations in South Africa

    Instructor-led in-person Classroom training is available for group batches. All other public cohorts are delivered as Instructor-led Live Virtual. See available cohorts.

    Quality by Design Training Location in 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 Training Location 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 banner

    Corporate QbD Training for Pharma Teams

    In South Africa

    • 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

    Trusted by Leading Enterprises in South Africa

    Aspen PharmacareAdcock IngramCipla MedproAscendis HealthBiovacKiara Health

    Enquire with us now

    Drop us a query and our learning consultant will reach out to you shortly

    Request Training Details

    Fill out this form and we will respond quickly.

    We also deliver Quality by Design Training across multiple cities in South Africa

    Quality by Design training for individuals and teams. Select a city in South Africa to view upcoming dates, formats and pricing.

    Quality by Design Training Course in BloemfonteinQuality by Design Training Course in Cape TownQuality by Design Training Course in CenturionQuality by Design Training Course in DurbanQuality by Design Training Course in East LondonQuality by Design Training Course in JohannesburgQuality by Design Training Course in Port ElizabethQuality by Design Training Course in Pretoria

    Frequently Asked Questions

    Here'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.