Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Drives Israeli PharmaBuild Quality in from the Start

    The Quality by Design Training in Israel is a one-day, instructor-led programme that teaches the Quality by Design (QbD) approach to pharmaceutical and biopharmaceutical development, where quality is engineered into the product from the design stage rather than tested in at the end. Grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines and the expectations of regulators such as the FDA and EMA, the course shows you how to move from the Quality Target Product Profile (QTPP) through critical quality attributes, risk assessment, design of experiments and the design space to a robust control strategy. These are the tools that Teva, Taro, Dexcel, Kamada and Israel's wider generics, API and biologics base build into development and regulatory submissions. It suits formulation scientists, process development engineers, analytical scientists, QA professionals and CMC regulatory specialists who want practical, on-the-job capability. This is a skills programme, not a certification course, so you leave with capability you can apply immediately and a course completion record from Invensis Learning.

    What Is Quality by Design and Why It Drives Israeli PharmaBuild Quality in from the Start

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    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the IsraelWho Can Enroll?

    What Quality by Design Skills Deliver for You and Your TeamPractical Value You Can Apply

    Your Quality by Design Career in IsraelRoles, Demand and Employers

    QbD skills open doors across Israel's pharmaceutical and biopharma sector, from formulation and process development to analytical science, QA and CMC regulatory affairs. As Teva, Taro, Dexcel, Kamada and a fast-growing biologics base build the approach into development and submissions, professionals who can apply QTPP, CQAs, DoE and control strategy are increasingly sought after. Quality by Design training helps professionals build exactly this capability. Here is what the Israeli market is telling us right now.

    The Market Forces Making QbD Essential in Israel

    Quality by Design is fast becoming a baseline skill in Israeli pharma. Give yourself or your team the QbD toolkit that regulators and employers now expect. Start today.

    Your Israel QbD Transformation

    Where You Stand Today

    The Shift Quality by Design Delivers

    Israel's pharmaceutical and biopharma sector is moving from testing quality in to designing it in, and employers increasingly separate QbD-capable professionals from the rest. Here is the shift this training delivers.

    Sources: GlobalData; Startup Nation Central; ICH Q8 to Q11 guidance; Israel pharma market data 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 Israel 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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    The Quality by Design Skills You Will BuildTools You Can Use Straight Away

    By the end of the training you will be able to run a full QbD workflow, from defining the target product profile to building a control strategy. Each skill maps to a real tool you can apply on live pharmaceutical and biopharma development projects.

    Build the Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, defining dosage form, strength, delivery, pharmacokinetic targets and quality standards as the design specification for the whole programme.

    Identify and Classify Critical Quality Attributes

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

    Run Risk Assessment with FMEA and Ishikawa

    Use fishbone diagrams and Failure Mode and Effects Analysis to rank CMA and CPP risks by severity, occurrence and detectability, focusing experimental effort where it matters most.

    Design Experiments and Define the Design Space

    Plan screening, response surface and mixture designs, interpret the models, and define a design space with Normal Operating Ranges and Proven Acceptable Ranges that keep CQAs in specification.

    Apply PAT and Build a Control Strategy

    Use Process Analytical Technology such as NIR and Raman to monitor quality in real time, and develop a risk-proportionate control strategy across materials, process, in-process controls and testing.

    Structure QbD Evidence for Regulatory Submissions

    Organise QTPP, CQAs, risk assessment, DoE results, design space and control strategy for the CTD Pharmaceutical Development section that FDA and EMA reviewers expect.

    Who Should TakeQuality by Design Training in Israel?

    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

    ILS 1280

    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.

    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

    • 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

    Designed for organizations that want to build capabilities at scale, standardize knowledge, and support workforce development through customized 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

    • 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

    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

    ILS 1280

    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.

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    Why Choose Invensis Learning for Quality by Design Training in IsraelExpert-Led, Practical and Flexible

    As a Quality by Design training company, Invensis Learning delivers structured QbD training for pharmaceutical and biopharma professionals and teams in Israel who want practical, regulator-aligned capability. Our programmes combine experienced trainers, flexible delivery formats, organised courseware and learner-focused support. Whether you enrol as an individual or plan corporate training for your team, we provide a professional learning experience built around practical understanding, real-world application and measurable outcomes.

    • Experienced trainers with real pharmaceutical and quality management expertise
    • Live virtual (online), classroom, onsite and corporate delivery formats
    • Practical, hands-on QbD exercises using realistic development scenarios
    • Courseware aligned to the ICH Q8 to Q11 QbD framework
    • ISO 9001:2015 certified for quality management
    • ISO 27001:2022 certified for information security
    • Dedicated learner support before, during and after the training
    • Global training partner with flexible delivery across Israel

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    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

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    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 IsraelAll our classroom training is now available online at your convenience

    Quality by Design in Israel

    Hilton Tel Aviv, 205, 1174, Tel-Aviv-Jaffa, the old north - the northern part, Tel-Aviv-Jaffa, Tel Aviv District, Tel Aviv District, 6340506, Israel

    Quality by Design in Israel

    David Intercontinental Hotel, 12, Yosef Levy, Tel Aviv-Yafo, Neve Tzedek, Tel Aviv-Yafo, Tel Aviv Subdistrict, Tel Aviv District, 6560475, Israel

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    Corporate Quality by Design Training in IsraelUpskill Your Team

    • Tailored QbD training for pharma and biopharma teams
    • Delivered onsite, live virtual or hybrid across Israel
    • Schedules aligned to your development and shift calendars
    • Case examples drawn from your own products and processes
    • Trainers with real pharmaceutical quality expertise
    • One shared QbD language across science, QA and regulatory teams
    • Progress tracking and dedicated coordination for group training

    Trusted by Pharmaceutical Teams

    TevaTaroDexcelKamadaPerrigo IsraelRafa Laboratories

    What Our Learners Say

    A Workflow I Could Use Immediately

    "The training finally connected the QbD tools I had read about into one workflow. Building a QTPP, mapping CQAs and reading a design space now feel routine, and I applied the risk assessment approach on my next formulation project within days."

    Yael Ben-David

    Formulation Scientist

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    DoE and Design Space Made Practical

    "The design of experiments and design space sessions were the most useful part for me. I understand how to move away from one-factor-at-a-time work and set operating ranges that hold up during scale-up and tech transfer."

    Amir Cohen

    Process Development Engineer

    0/0

    Strong Analytical and PAT Focus

    "Clear, well-paced and grounded in real pharmaceutical examples. The PAT and control strategy content helped me see how in-process monitoring links back to critical quality attributes rather than sitting apart from the lab work."

    Noa Levi

    Analytical / QC Scientist

    0/0

    A Shared Language Across the Team

    "We trained a cross-functional team together and it gave formulation, process and QA a shared language. Our development reports and control strategies are now far more consistent, and reviews move faster because everyone works from the same QbD framework."

    Daniel Katz

    QA Manager, Generics Manufacturer

    0/0

    Submission-Ready QbD Capability

    "The corporate session mapped QbD evidence to the Pharmaceutical Development section of our submissions. My regulatory team is more confident preparing and defending design space and control strategy content for FDA and EMA reviewers."

    Michal Shapira

    Head of CMC Regulatory Affairs, Biopharma

    0/0



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

    QbD training is a practical, non-certification programme that teaches the Quality by Design approach to pharmaceutical and biopharmaceutical development. It covers the ICH Q8 to Q11 framework and tools such as QTPP, critical quality attributes, risk assessment, design of experiments, design space and control strategy.

    General

    What is Quality by Design (QbD) training?

    QbD training is a practical, non-certification programme that teaches the Quality by Design approach to pharmaceutical and biopharmaceutical development. It covers the ICH Q8 to Q11 framework and tools such as QTPP, critical quality attributes, risk assessment, design of experiments, design space and control strategy.

    Who should attend the QbD training in Israel?

    The course suits formulation scientists, process development engineers, analytical scientists, QA professionals, manufacturing technical managers and CMC regulatory specialists in pharmaceutical, biopharma, API, CDMO and medical device organisations who want to apply QbD in development and submissions.

    Is Quality by Design worth it for pharma professionals?

    Yes. QbD is increasingly expected by the FDA and EMA and built into how Teva, Taro, Dexcel and Israel's wider pharma base develop products. Professionals who can apply the method are more effective on projects and more sought after by leading employers.

    Which ICH guidelines does the course cover?

    The training is grounded in ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. It also references related FDA PAT guidance and EMA expectations for QbD-based 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 course introduces QbD from first principles in a development context.

    Pricing

    How much does the QbD training cost in Israel?

    Pricing depends on the delivery format, group size and whether the training is public or corporate, and is available on request. Contact a learning advisor for a quote tailored to your needs in Israel.

    What is included in the course fee?

    The fee typically includes instructor-led training across all QbD modules, courseware and learning resources, hands-on tool exercises, case study material and a course completion record from Invensis Learning. Request a quote for full details.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for pharma and biopharma teams. Ask about group pricing for your organisation in Israel.

    Are there payment options available?

    We accept major payment methods and can discuss options for individual and corporate enrolments. Speak with a learning advisor to choose the arrangement that suits you.

    Is there any additional certification or credential fee?

    No. This is a non-certification skills course, so there is no external credential or associated fee. You receive a course completion record from Invensis Learning at no extra cost.

    Certification

    Do I receive a certification after the training?

    No external certification is awarded, because QbD training is a practical skills course with no governing body. You receive a course completion record from Invensis Learning that confirms you completed the programme.

    Is there an exam or formal assessment?

    No. There is no examination. Your learning is reinforced through hands-on QbD tool exercises, such as building a QTPP, identifying CQAs, running risk assessment and interpreting a design space, plus case study discussion during the programme.

    Is QbD an accredited or certified qualification?

    No. Quality by Design is a methodology, not a credential, so the training is not accredited and there is no certifying body. The value lies in the practical capability you gain and can apply immediately at work.

    Will the training help with FDA and EMA submissions?

    Yes. The course shows how QbD outputs, including QTPP, critical quality attributes, design space and control strategy, are structured for the Pharmaceutical Development section of CTD submissions that the FDA and EMA expect.

    How is my learning reinforced without an assessment?

    Through applied practice. You work through realistic pharmaceutical scenarios, building QbD deliverables step by step, so you leave able to construct QTPPs, lead CQA and risk workshops, plan DoE and develop a control strategy.

    Course Content

    What topics does the QbD course cover?

    The programme covers QbD principles and the ICH regulatory context, QTPP and CQAs, risk assessment with Ishikawa and FMEA, design of experiments and design space, PAT and control strategy, and QbD in practice through case studies and lifecycle management.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, run FMEA-based risk assessment, plan and interpret design of experiments, define a design space with operating ranges, and build a control strategy for regulatory submission.

    Does the course cover both small molecules and biologics?

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

    Are there hands-on exercises?

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

    How long is the QbD training?

    The programme is delivered in one day of eight hours, covering all QbD modules with concept explanations, the ICH regulatory context, real-world case examples and hands-on tool exercises. An extended half-day format over two days is also available.

    Enrollment

    How do I enrol in the QbD training in Israel?

    You can enrol through Invensis Learning. Choose your preferred format, confirm your place, and you will receive access to schedules, courseware and learning resources. Talk to a learning advisor to get started.

    What delivery formats are available?

    The training is available as live virtual (online) instructor-led sessions, in-person classroom training, onsite delivery and customised corporate group training, so you can choose the format that fits your schedule and team. Many teams take the Quality by Design course online through the live virtual option.

    Can the course be delivered online for teams in Israel?

    Yes. We deliver QbD training online through live virtual instructor-led sessions for individuals and teams across Israel, as well as onsite and hybrid options for corporate groups. Ask about scheduling for your team.

    How soon can I start?

    Public sessions run on a regular schedule, and corporate sessions can be arranged around your team's availability. See upcoming schedules or contact a learning advisor to confirm the next suitable date.

    Can I reschedule my enrolment?

    Yes. Flexible options let you reschedule or move to another session where available. Contact our support team to arrange a change to your enrolment.