Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training in Ghana?UntitledA Science-Led Approach to Product Quality

    Quality by Design (QbD) training in Ghana teaches pharmaceutical and biopharmaceutical professionals to build quality into products from the design stage rather than test it in at the end. You learn the systematic, science-based QbD approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the FDA and EMA. Working through real development scenarios, you 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. The training suits formulation scientists, process and analytical scientists, quality assurance professionals and regulatory affairs specialists across Ghana's growing local manufacturing sector. As Ghana's Food and Drugs Authority tightens GMP expectations and local firms pursue WHO prequalification and AfCFTA export markets, QbD capability is a genuine workplace advantage. Start building it with Invensis Learning.

    What Is Quality by Design Training in Ghana?A Science-Led Approach to Product Quality

    Quality by Design (QbD) training in Ghana teaches pharmaceutical and biopharmaceutical professionals to build quality into products from the design stage rather than test it in at the end. You learn the systematic, science-based QbD approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the FDA and EMA.

    Working through real development scenarios, you 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. The training suits formulation scientists, process and analytical scientists, quality assurance professionals and regulatory affairs specialists across Ghana's growing local manufacturing sector.

    As Ghana's Food and Drugs Authority tightens GMP expectations and local firms pursue WHO prequalification and AfCFTA export markets, QbD capability is a genuine workplace advantage. Start building it with Invensis Learning.

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    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Ghana 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 Ghana 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 Ghana

    • Instructor-led training formats available for individual learners and corporate teams across the Ghana
    • 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 Ghana
    • 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 Ghana 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 GhanaWho 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 QbD Skills Are Worth BuildingReal Capability for Pharmaceutical Work

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical professionals move from testing quality in at the end to designing it in from the start. You leave able to apply QbD tools to your own product and process development work. Whether you work in formulation, analytical development, process engineering, quality assurance or regulatory affairs, the programme builds capability you can use immediately.

    If you want to develop products that are consistent, compliant and ready for regulatory scrutiny, QbD is a foundational skill. You gain the tools, the ICH context and the hands-on practice to apply it with confidence.

    • Apply the full QbD toolkit, from QTPP and CQA identification to design space and control strategy, on live development projects
    • Replace slow trial-and-error development with a systematic, science-based method that regulators increasingly expect
    • Lead CQA and risk-assessment workshops using Ishikawa diagrams and FMEA with confidence
    • Plan and interpret Design of Experiments studies to define a robust design space
    • Grow your value to Ghana's pharmaceutical, biopharma and API manufacturers pursuing GMP and WHO prequalification
    • Contribute directly to CTD Section 3.2.P.2 pharmaceutical development submissions
    • Build cross-functional credibility across formulation, analytical, quality and regulatory teams
    For Organizations

    For Organizations

    Quality by Design group training equips cross-functional teams to build quality into products from development. Delivered for R&D, manufacturing, quality and regulatory groups, it standardises how your organisation approaches product and process development. For manufacturers investing in GMP upgrades and export ambitions, this training creates a practical, consistent QbD capability.

    If your organisation is scaling local production or targeting WHO prequalification and AfCFTA markets, QbD training gives your teams the shared tools and ICH-aligned discipline to develop compliant, robust products.

    • Builds a shared QbD language across formulation, analytical, quality and regulatory teams
    • Reduces manufacturing deviations and out-of-specification batches through better process understanding
    • Strengthens readiness for Ghana FDA GMP inspections and WHO prequalification
    • Supports fewer post-approval changes and stronger regulatory relationships
    • Can be delivered onsite so teams apply QbD to live in-house development projects
    • Improves product consistency and patient safety across the portfolio
    • Develops in-house capability to author QbD-based CTD submissions

    QbD Careers in Ghana's Pharma SectorIn-Demand Roles and Employers

    Quality by Design skills are increasingly valuable across Ghana's pharmaceutical sector, where local manufacturers, biopharma firms and regulatory teams are under pressure to meet stricter GMP and international quality standards. As the Food and Drugs Authority raises the bar and firms target WHO prequalification and AfCFTA export markets, professionals who can build quality into products from development are sought after, making Quality by Design training a valuable career investment. Here is what the market is telling us right now.

    38+

    PMAG member manufacturers in Ghana

    Pharmaceutical Manufacturers Association of Ghana

    GH₵70,880

    Regulatory Affairs Specialist pay, Accra

    average per year, WorldSalaries 2026

    GH₵85,700

    Formulation / R&D Scientist pay, Ghana

    average per year, WorldSalaries 2026

    2x by 2030

    AIM2030 goal for African pharma capacity

    regional manufacturing initiative

    SECTORS HIRING

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

    GROWTH TRENDS

    • —AIM2030 drive to double African pharma manufacturing capacity
    • —Ghana FDA tightening GMP and quality-assurance expectations
    • —Local firms pursuing WHO prequalification for funded tenders
    • —AfCFTA opening regional export markets for Ghanaian medicines
    • —Reported shortages in regulatory and pharmaceutical sciences
    • —24-Hour Economy policy expanding local production capacity

    Sources: WorldSalaries, PayScale, Paylab (Ghana) 2026; PMAG; Ghana FDA; AIM2030 and Ghana News Agency (Expo 2026).

    The Pressures Making QbD Essential in Ghana

    GMP Compliance Gap

    Ghana's Food and Drugs Authority has raised GMP expectations, yet many local manufacturers still rely on end-product testing rather than the built-in quality control that QbD provides.

    QbD builds process understanding and control

    WHO Prequalification Barrier

    No Ghanaian firm currently holds WHO prequalification. Reaching it demands the process understanding, design space and control strategy that QbD methodology is built to deliver.

    QbD supports design space and control strategy

    Regulatory Science Skills Shortage

    Stakeholders cite shortages in pharmaceutical sciences, regulatory science and clinical research, leaving few professionals able to lead QbD-based development and submissions.

    QbD develops scarce development expertise

    AfCFTA Export Readiness

    To sell across African markets under AfCFTA, Ghanaian medicines must meet harmonised international standards, which QbD-based development and CTD documentation directly support.

    QbD supports harmonised, submission-ready dossiers

    Costly Batch Failures

    Without mechanistic process understanding, manufacturers face deviations and out-of-specification batches. QbD reduces failures by holding quality within a proven design space.

    QbD reduces deviations and rework

    Scaling Local Production

    Ghana's 24-Hour Economy and AIM2030 goals push firms to expand output. QbD helps teams scale up processes predictably while keeping product quality steady.

    QbD enables predictable scale-up

    Sources: Ghana FDA; PQM+ (USP); AIM2030; Ghana News Agency (Expo 2026); ResearchGate (Ghana pharma 24-Hour Economy).

    QbD is a practical, career-defining skill for pharmaceutical professionals in Ghana. Join teams building quality into products from the design stage. Start your journey today.

    Your Ghana QbD Transformation

    From Testing Quality in to Designing It In

    The QbD Skills Shift

    Ghana's pharmaceutical sector is moving from end-product testing towards built-in, science-based quality, and employers increasingly separate professionals who can apply QbD from those who cannot. Here is the shift this training delivers.

    Today

    You rely on end-product testing to catch quality problems after the fact

    After QbD

    You build quality in from development using QTPP, CQAs and a defined design space

    Today

    Development runs on trial and error, with slow, hard-to-defend results

    After QbD

    You plan Design of Experiments studies that give clear, regulator-ready process understanding

    Today

    Submissions feel like a scramble to justify specifications after the fact

    After QbD

    You author QbD evidence for CTD Section 3.2.P.2 with a clear risk-based rationale

    You master QbD

    Before

    Quality skills tied mainly to inspection, testing and paperwork

    Now you have

    A systematic, ICH-aligned QbD approach recognised across the pharmaceutical industry

    Before

    Limited say in how products and processes are actually designed

    Now you have

    The tools to lead CQA identification, risk assessment and control-strategy work

    Before

    Development capability that varies from project to project

    Now you have

    A repeatable method that improves product consistency and patient safety

    Before

    Skills valued mainly by your current employer

    Now you have

    Capability sought by manufacturers, CDMOs and regulators across Ghana and beyond

    "The gap between testing quality and designing it in is what separates modern pharma teams, and the manufacturers pursuing WHO prequalification already know it."

    Join 50,000+ professionals who trained with Invensis Learning and built new capability.

    Sources: WorldSalaries, Paylab (Ghana) 2026; Ghana FDA; PQM+ (USP).

    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 Ghana 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.

    • 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.

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    The QbD Skills You Will BuildPractical Tools for Pharmaceutical Development

    This Quality by Design training builds hands-on capability across the full QbD workflow, from defining the target product profile to designing the control strategy. By the end you can apply each tool to real pharmaceutical development work.

    Define the Quality Target Product Profile

    Build a QTPP from clinical and patient needs, setting the design specification that drives the whole QbD programme for a small molecule or biologic product.

    Identify and Classify Critical Quality Attributes

    Use prior knowledge and risk tools to pinpoint the CQAs, such as assay, dissolution, impurities and, for biologics, glycosylation and aggregation, that determine product quality.

    Run QbD Risk Assessments

    Apply Ishikawa (fishbone) diagrams and FMEA with Risk Priority Numbers to link Critical Material Attributes and Critical Process Parameters to each CQA and focus your development effort.

    Plan and Interpret Design of Experiments

    Choose screening, response-surface and mixture designs, then read the models to define a design space with Normal Operating and Proven Acceptable Ranges.

    Apply Process Analytical Technology

    Understand how PAT tools such as NIR and Raman spectroscopy enable real-time monitoring and real-time release testing within a QbD control strategy.

    Build the Control Strategy and CTD Evidence

    Turn risk-assessment and DoE outputs into a risk-proportionate control strategy and document it for CTD Section 3.2.P.2 pharmaceutical development submissions.

    Who Should TakeQuality by Design Training in Ghana?

    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 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 395

    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 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 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 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

    USD 395

    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 in GhanaYour QbD Learning Partner

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and teams across Ghana who want to build quality into products from development. Our programmes combine experienced, industry-practitioner trainers, flexible delivery formats and structured, ICH-aligned courseware. As a trusted Quality by Design training company in Ghana, we are committed to practical, job-ready learning. Whether you enrol as an individual or arrange corporate training for your team, we focus on real-world application, hands-on QbD exercises and measurable learning outcomes, backed by ISO-certified quality and information-security standards.

    • Experienced trainers with real pharmaceutical and QbD practitioner expertise
    • Instructor-led training delivered online (live virtual), in classrooms and onsite in Ghana
    • Structured, ICH-aligned courseware covering Q8 to Q11 and the full QbD toolkit
    • Hands-on exercises applying QTPP, CQA, risk assessment and DoE to real scenarios
    • Flexible schedules for individual learners and corporate teams
    • Course completion certificate from Invensis Learning
    • Dedicated learner support before, during and after the training
    • ISO 9001:2015 and ISO 27001:2022 certified training operations

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    500+

    Corporate Clients

    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 GhanaAll our classroom training is now available online at your convenience

    Quality by Design in Ghana

    Movenpick Ambassador Hotel, Liberia Avenue, West Ridge, Accra, Korle-Klottey Municipal District, Greater Accra Region, Ghana

    Quality by Design in Ghana

    Kempinski Hotel Gold Coast City, 66, Guinea Bissau Loop, Ridge, Ministerial Area, Accra, Korle-Klottey Municipal District, Greater Accra Region, Ghana

    corporate banner

    Corporate Quality by Design TrainingFor Your Teams

    Untitled

    • Customised QbD training for R&D, manufacturing, quality and regulatory teams
    • Flexible delivery through onsite, live virtual, hybrid or blended formats
    • Schedules aligned with your team's availability and project timelines
    • Trainers with real pharmaceutical and biopharma development experience
    • Teams apply QbD tools to your own live development projects
    • Dedicated coordination and learner support throughout
    • Scalable delivery for teams across Ghana and beyond

    Leading Pharmaceutical Manufacturers

    KinapharmaErnest ChemistsUnichem GhanaEntrance PharmaceuticalsDanadamsAyrton Drug

    What Our Learners Say

    Untitled

    QbD Tools I Use Every Week

    "The training finally connected the ICH theory to daily work. I now build a QTPP and run CQA identification with the team instead of relying on end-product testing. The design space exercise was the highlight for me."

    Kwame Mensah

    Formulation Scientist

    Untitled

    0/0

    DoE Made Practical

    "The Design of Experiments sessions were practical and clear. I can now plan screening and response-surface studies and read the models to set proven acceptable ranges, which has changed how our lab approaches process development."

    Ama Boateng

    Analytical Scientist

    Untitled

    0/0

    Confident Leading Risk Assessments

    "Working through FMEA and Ishikawa diagrams on real scenarios gave me the confidence to lead risk assessments. The link between risk, DoE and the control strategy is much clearer now, and it helps with our submission documentation."

    Yaw Owusu

    Regulatory Affairs Officer

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    A Shared Language for the Whole Team

    "We ran this as onsite training for a cross-functional group. Trainers tailored the exercises to our own products, and our formulation, quality and regulatory people now share one QbD language. It has improved how our development projects run."

    Efua Sarpong

    Head of Learning and Development, Pharmaceutical Manufacturer

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    The Right Foundation for Prequalification

    "As we prepare for GMP upgrades and prequalification, this training gave our quality team the process-understanding mindset we needed. Deviations are easier to prevent when quality is designed into the process rather than tested at the end."

    Kofi Adjei

    Quality Assurance Manager, Generics Manufacturer

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    Frequently Asked QuestionsHere's everything you may ask...

    Quality by Design, or QbD, training is a one-day, practical programme that teaches pharmaceutical and biopharma professionals to build quality into products from the design stage. It covers the ICH Q8(R2), Q9, Q10 and Q11 approach and tools such as QTPP, CQAs, risk assessment, DoE, the design space and control strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design, or QbD, training is a one-day, practical programme that teaches pharmaceutical and biopharma professionals to build quality into products from the design stage. It covers the ICH Q8(R2), Q9, Q10 and Q11 approach and tools such as QTPP, CQAs, risk assessment, DoE, the design space and control strategy.

    Is QbD training worth it for pharma professionals in Ghana?

    Yes. As Ghana's Food and Drugs Authority raises GMP expectations and firms target WHO prequalification and AfCFTA export markets, professionals who can design quality into products are in demand. QbD skills apply directly across formulation, analytical, quality and regulatory roles.

    Who should attend the QbD training?

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

    Do I need prior QbD experience to join?

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

    Which ICH guidelines does the training cover?

    The training is grounded in the ICH Q8(R2) Pharmaceutical Development guideline, together with ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System) and ICH Q11 (Drug Substances). It also reflects FDA and EMA expectations for QbD-based development.

    Pricing

    How much does QbD training cost in Ghana?

    Fees vary by delivery format (live virtual, classroom or corporate onsite) and group size, so pricing is available on request. The fee covers courseware, hands-on exercises, learner support and a course completion certificate. Request a quote for current rates.

    What is included in the QbD course fee?

    The fee typically includes ICH-aligned courseware, hands-on QbD tool exercises, pharmaceutical case studies, downloadable reference materials, learner support and a course completion certificate from Invensis Learning.

    Do you offer group or corporate rates for QbD training?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for R&D, manufacturing, quality and regulatory teams. Contact us for a tailored quote for your organisation.

    Are there any extra fees beyond the training?

    No. This is a non-assessment skills programme, so there are no external testing or credential fees. The training fee covers the full one-day programme, materials and your course completion certificate.

    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.

    Assessment

    Does the QbD course include a test or assessment?

    No. Quality by Design is a non-assessment skills course with no test. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion during the one-day programme.

    Do I receive a certificate after the training?

    Yes. You receive a course completion certificate from Invensis Learning after finishing the programme. This is a practical skills course, so it does not award a formal credential through an external awarding body.

    How is learning reinforced during the course?

    Learning is applied throughout the day using hands-on activities: constructing a QTPP, identifying CQAs, building Ishikawa diagrams, running an FMEA and selecting DoE designs, all set in realistic pharmaceutical development scenarios.

    How long is the QbD training?

    The programme runs for one day (8 hours) and can also be delivered as two half-day sessions. It covers the full QbD workflow, from principles and the ICH context through QTPP, CQAs, risk assessment, DoE, PAT and the control strategy.

    Is the QbD training an accredited programme?

    It is a vendor-neutral, practical skills course with no external awarding body. The value lies in applying QbD methodology and tools immediately at work. Invensis Learning delivers it under ISO 9001:2015 and ISO 27001:2022 certified operations.

    Course Content

    What topics are covered in the QbD training?

    The course covers QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment (Ishikawa and FMEA), Design of Experiments and design space, Process Analytical Technology and the control strategy, plus case studies and CTD submission content.

    Does the course cover both small molecule and biologic products?

    Yes. The training addresses QbD for small molecule drug products such as tablets and injectables, and for biopharmaceuticals such as monoclonal antibodies, with case study examples drawn from both product types.

    Will I learn Design of Experiments (DoE) in QbD?

    Yes. You learn how DoE replaces one-factor-at-a-time testing, how to select screening, response-surface and mixture designs, and how to interpret the models to define a design space with Normal Operating and Proven Acceptable Ranges.

    Are there hands-on exercises in the course?

    Yes. Practical exercises run throughout the day, including QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams, FMEA and DoE design selection, all applied to realistic development scenarios.

    Is the courseware aligned with current ICH guidelines?

    Yes. The courseware reflects the current ICH Q8(R2), Q9, Q10 and Q11 guidelines and how their QbD principles are applied in pharmaceutical development and CTD Section 3.2.P.2 submissions.

    Enrollment

    How do I enrol in the QbD training in Ghana?

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

    What training formats are available?

    We offer online (live virtual) instructor-led training, classroom training and customised corporate onsite training, so you can choose the format that fits your schedule and team. Many learners choose the Quality by Design course online for its flexibility.

    Can a beginner take this course?

    Yes. There are no prerequisites and the course introduces QbD from first principles. It is designed for pharmaceutical professionals new to QbD as well as those wanting to formalise and extend their existing knowledge.

    Can the training be delivered onsite for our team?

    Yes. Corporate onsite delivery lets a cross-functional team train together and apply QbD tools to your own live development projects. Contact us to arrange a session and get a group quote.

    Can I reschedule my enrolment to another batch?

    Yes. Flexi options let you reschedule or transfer to another batch on selected plans. Contact our support team and we will help you move to a date that works for you.