Quality by Design Training in Austria

Design Quality in from the Start

Build the practical QbD capability that Austria's pharmaceutical and biopharmaceutical employers value. This instructor-led programme shows formulation, process, analytical and quality professionals how to design quality into products from the outset, using the ICH Q8, Q9, Q10 and Q11 framework alongside QTPP, Critical Quality Attributes, risk assessment, Design of Experiments and the control strategy.

Flexible

Duration

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Hours

13.3K+ already enrolled

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Master Quality by Design and Lead Excellence in Austria

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EUR 430

What the Quality by Design Approach Delivers in AustriaDesigning Quality in from Day One

The Quality by Design Training in Austria is a practical, one-day programme that teaches the Quality by Design (QbD) approach to pharmaceutical and biopharmaceutical product and process development. QbD is a systematic, science-based method that builds quality into a product from the design stage rather than testing it in at the end.

The course is grounded in the ICH guidelines that define modern pharmaceutical development: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. You learn to work the way the FDA and the EMA now expect, using the Quality Target Product Profile, Critical Quality Attributes, risk assessment, Design of Experiments, the design space and a robust control strategy.

Delivered in live online, classroom and corporate formats, it suits formulation scientists, process engineers, analytical scientists and quality and regulatory teams across Austria's pharma, biopharma and CDMO sector, so you can apply QbD tools to live projects straight away.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Austria 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 Austria 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 Austria

Instructor-led training formats available for individual learners and corporate teams across the Austria
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 Austria
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 Austria 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 AustriaWho 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

The Real-World Value of QbD TrainingFor Individuals and Organisations

For Individuals

Quality by Design training helps pharmaceutical professionals move from trial-and-error development to a systematic, science-based approach. You gain the tools to design quality into products and defend those decisions with data. Whether you work in formulation, process development, analytics, quality assurance or regulatory affairs, the programme builds capability you can apply to live projects.

If you want to develop products that meet ICH and regulator expectations first time, QbD is a practical, immediately useful skill set. You leave with a clear method and a toolkit you can put to work in your own organisation across Austria.

Build quality into products from the design stage instead of relying on end-product testing
Apply QTPP, CQA identification and risk assessment to real formulation and process work
Plan and interpret Design of Experiments to define a robust design space
Develop control strategies and use PAT to keep processes within the design space
Speak the ICH Q8 to Q11 language that Austrian pharma and biopharma employers expect
Contribute confidently to the CMC sections of regulatory submissions
Stand out for scientist, process and quality roles across Austria's life sciences sector

For Organizations

QbD group training helps organisations build science-based development capability by equipping cross-functional teams with structured knowledge and practical tools. It can be delivered for formulation, process, analytical, quality and regulatory groups. For organisations that want fewer deviations and stronger submissions, the training provides a scalable, flexible solution.

If your teams still rely on end-product testing and empirical fixes, QbD training creates a shared, science-based method. Teams gain a consistent approach to QTPP, risk assessment, design space and control strategy that supports quality and compliance across the site.

Standardise a science-based development approach across formulation, process and quality teams
Reduce manufacturing deviations and out-of-specification results through better process understanding
Prepare stronger CMC submissions aligned to ICH Q8, Q9, Q10 and Q11
Cut the burden of post-approval changes by defining and justifying a design space
Build a shared QbD language across cross-functional development groups
Support technology transfer and scale-up with documented process understanding
Train whole teams together on their own live development projects

Where Quality by Design Roles Lead in AustriaAcross Pharma and Biotech

Quality by Design skills open doors across Austria's pharmaceutical and biopharmaceutical sector, from formulation and process development to analytics, quality assurance and CMC regulatory affairs. With around 18,000 people employed in the industry and major sites expanding in Vienna and Tyrol, employers increasingly want scientists who can apply QbD tools and read the ICH framework. Roles run from QC analyst through to QbD lead, and here is what the Austrian market is telling us now.

18,000+

Pharma professionals employed, Austria

industry workforce, 2023

330+

Pharma and biotech companies, Austria

advantageaustria / trade.gov

€63,000

Regulatory affairs specialist pay, Austria

average per year, SalaryExpert 2026

€500m

Novartis Tyrol cell-culture investment

around 350 new jobs, investinaustria

SECTORS HIRING

—Biopharmaceutical Manufacturing (Vienna, Tyrol)
—Generics and Secondary Manufacturing
—Contract Development and Manufacturing (CDMOs)
—Plasma and Vaccine Production
—Regulatory Affairs and CMC
—Medical Devices and Diagnostics

GROWTH TRENDS

—Boehringer Ingelheim and Octapharma expanding biopharma sites in Vienna
—Novartis and Sandoz scaling cell-culture and antibiotic production in Tyrol
—Austria positioned as a DACH formulation and secondary-manufacturing hub
—Rising FDA and EMA expectation of QbD evidence in submissions
—Pharmaceutical net exporter contributing around 1.8% of GDP
—Growing demand for scientists fluent in DoE and design space

Sources: advantageaustria, trade.gov, investinaustria, SalaryExpert, Glassdoor, Paylab (Austria) 2025-2026.

Designation

Quality by Design Professionals in Austria : Salary Insights and Trends

Hiring Companies in Austria

€35K

Min

€48K

Average

€65K

Max

Paylab · Glassdoor (Austria) 2026

SandozGL PharmaGenericonCroma-Pharma

Source: Sandoz · GL Pharma · Genericon · Croma-Pharma

Why QbD Expertise Is in Demand Across Austria

Rising Regulatory Expectations

The FDA and EMA increasingly expect QbD evidence in submissions. Austrian developers need teams who can produce a QTPP, design space and control strategy that reviewers accept.

QbD builds ICH-aligned development skills

Biopharma Scale-Up Complexity

New cell-culture and biologics capacity in Vienna and Tyrol demands robust process understanding. QbD gives teams the DoE and design-space tools to scale up with confidence.

QbD builds design-space and DoE skills

Secondary Manufacturing Variability

As a DACH formulation and packaging hub, Austrian sites run frequent technology transfers. QbD control strategies keep quality consistent when processes move between sites.

QbD builds control-strategy skills

Plasma and Biologics Consistency

Plasma products and biologics are process-defined and sensitive to conditions. Identifying CQAs and assessing risk with FMEA is essential to keep every batch within specification.

QbD builds CQA and risk-assessment skills

Talent Gap in DoE and Design Space

Austria has deep GMP experience but fewer scientists fluent in statistical DoE and design-space definition, making QbD-skilled professionals scarce and sought-after.

QbD makes skilled scientists stand out

Cost and Yield Pressure in Generics

Margin pressure in generics and secondary manufacturing pushes sites to reduce deviations and rework. QbD process understanding improves yield, reliability and release times.

QbD builds process-optimisation skills

Sources: trade.gov, advantageaustria, investinaustria, Glassdoor, Hays (Austria) 2025-2026.

QbD is more than a method. It is the skill that Austria's pharmaceutical and biopharmaceutical employers now expect. Join professionals who design quality into products from the start. Begin your journey today.

Your Austria QbD Career Shift

Your Shift from Quality by Testing to Quality by Design

What Changes on the Job

Austria's pharmaceutical and biopharmaceutical market is expanding through biologics, plasma and secondary manufacturing, and employers increasingly separate science-based development from empirical fixing. Here is which side of that line you want to be on.

Today

Recognised for delivery, but not for a science-based development method

After QbD

Fluent in the QbD approach that Austrian pharma and biopharma employers value

Today

Recognised for delivery, but not for a science-based development method

Today

Limited to project-level tasks with narrow influence

After QbD

Able to lead QTPP, CQA and design-space work across a development team

Today

Limited to project-level tasks with narrow influence

Today

Pay tracks general lab and QA bands with limited leverage

After QbD

Regulatory and QbD-skilled roles in Austria reach €78,000 and above

Today

Pay tracks general lab and QA bands with limited leverage

You Master QbD

Before

Quality is checked at the end through inspection and end-product testing

Now you have

Quality is designed into the product from the QTPP onwards

Before

Quality is checked at the end through inspection and end-product testing

Before

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

Now you have

You use structured DoE to understand and control the design space

Before

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

Before

Risk decisions rely on opinion and past habit

Now you have

You prioritise risks with Ishikawa diagrams and FMEA, backed by data

Before

Risk decisions rely on opinion and past habit

Before

Submissions struggle to explain why the process is controlled

Now you have

You present a clear control strategy aligned to ICH Q8 to Q11

Before

Submissions struggle to explain why the process is controlled

"The move from testing quality in to designing it in is the difference employers now look for, and Austria's expanding biopharma sites already know it."

Join 50,000+ professionals who trained with Invensis Learning and built practical, job-ready skills.

Sources: SalaryExpert, Glassdoor, Paylab (Austria) 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 Austria 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 Skills You Will BuildFrom QTPP to Control Strategy

This one-day programme builds practical capability across the whole Quality by Design workflow. By the end you can construct a QTPP, identify CQAs, run risk assessments, design experiments, define a design space and develop a control strategy for real pharmaceutical products.

Build a Quality Target Product Profile

You will learn how to apply the full Quality by Design toolkit to pharmaceutical development, starting with a QTPP that captures the quality, safety and efficacy the product must achieve from clinical and patient needs.

Identify and Classify Critical Quality Attributes

Determine the physical, chemical, biological and microbiological attributes that are critical to quality, and link each CQA to material attributes (CMAs) and process parameters (CPPs).

Run Risk Assessments with Ishikawa and FMEA

Use fishbone diagrams to map sources of variation and FMEA with Risk Priority Numbers to prioritise the material and process variables that most affect quality.

Design Experiments and Define the Design Space

Plan screening, response-surface and mixture Design of Experiments, interpret the models, and define a design space with Normal Operating and Proven Acceptable Ranges.

Apply PAT and Build a Control Strategy

Use Process Analytical Technology such as NIR and Raman for real-time monitoring, and develop a risk-proportionate control strategy that keeps the process within the design space.

Structure QbD Evidence for Submissions

Present QTPP, risk assessment, DoE and control-strategy evidence in the CTD Pharmaceutical Development section, and manage post-approval change in a QbD lifecycle.

Who Should TakeQuality by Design Training in Austria?

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

EUR 430

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 Choose Invensis Learning for Quality by Design Training in AustriaExpert-Led, ISO-Certified Delivery

As a trusted Quality by Design training company in Austria, Invensis Learning delivers structured Quality by Design training for pharmaceutical professionals and organisations that want to build practical, science-based development capability. Our programmes combine experienced trainers, flexible delivery and hands-on QbD tool exercises grounded in the ICH framework. Whether you enrol as an individual or arrange corporate training for your team in Austria, you get a professional learning experience built around real-world application and measurable outcomes. Invensis Learning is ISO 9001:2015 and ISO 27001:2022 certified, so quality and data security are assured.

Experienced trainers with real pharmaceutical and quality-management practice
Online (live virtual), classroom and onsite delivery to fit your schedule
Hands-on QbD exercises using realistic pharmaceutical development scenarios
Structured, up-to-date courseware aligned to the ICH Q8 to Q11 guidelines
Customised corporate training for pharma and biopharma teams in Austria
ISO 9001:2015 certified for quality management
ISO 27001:2022 certified for information security
Dedicated learner support before, during and after the training

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 AustriaAll our classroom training is now available online at your convenience

Quality by Design in Austria

DAS EDELWEISS Salzburg Mountain Resort, Unterbergstraße 65, 5611 Großarl, Austria

Quality by Design in Austria

The Ritz-Carlton, Vienna, Schubertring 5-7, 1010 Wien, Austria

Quality by Design in Austria

DAS EDELWEISS Salzburg Mountain Resort, Unterbergstraße 65, 5611 Großarl, Austria

Quality by Design in Austria

The Ritz-Carlton, Vienna, Schubertring 5-7, 1010 Wien, Austria

Corporate Quality by Design TrainingFor Teams Across Austria

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Suitable for small, medium and large development teams
Customised schedules built around your project and shift patterns
Live virtual, onsite or hybrid delivery across Austria
Trainers with real pharmaceutical and biopharmaceutical experience
QbD tools applied to your own live product development projects
Dedicated coordination and support for group programmes
Scalable delivery for single sites or multi-country teams

What Our Learners Say

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QbD Tools I Could Apply Straight Away

"The training finally connected the ICH theory to daily formulation work. Building a QTPP and mapping CQAs to process parameters made immediate sense, and I used the risk-assessment method on a live project the following week."

Markus Gruber

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Design of Experiments Made Clear

"The DoE and design-space sessions were the highlight. As an analytical scientist I now understand how our data feeds the control strategy and PAT decisions, not just the release specification."

Elena Wagner

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Practical and Well Paced

"A well-structured day that moved from ICH context through QTPP, risk assessment and design space to the control strategy. The scale-up examples were relevant to our biologics process."

Thomas Hofer

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A Shared Method Across Our Teams

"We ran this as an in-house session for our development and quality teams. It gave everyone a shared QbD language and a consistent approach to design space and control strategy, which has already reduced back-and-forth in reviews."

Katharina Mayer

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Tailored to Our Submission Needs

"The corporate programme was tailored to our CMC submission pipeline. The trainer used our own product scenarios, so the QbD framework landed with the team and mapped directly to our regulatory work."

Stefan Berger

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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, one-day course on the QbD approach to pharmaceutical product and process development. It teaches how to build quality into a product from the design stage using the ICH Q8, Q9, Q10 and Q11 framework, QTPP, Critical Quality Attributes, risk assessment, Design of Experiments and the control strategy.

General

What is Quality by Design (QbD) training?

Who should attend the QbD training in Austria?

It suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and CMC regulatory affairs specialists in Austria's pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to apply QbD in development and submissions.

Is QbD training worth it for pharmaceutical professionals?

Yes. QbD is the science-based method that the FDA and EMA now expect and that Austria's expanding biopharma sites increasingly hire for. The skills apply immediately to formulation, process, analytical, quality and regulatory work, and help you stand out for scientist and quality roles.

Which ICH guidelines does the training cover?

The course is grounded in ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. These guidelines define modern QbD and shape FDA and EMA expectations for development 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 pharmaceutical development context.

Pricing

How much does QbD training cost in Austria?

Fees vary by delivery format (live online, classroom or corporate), group size and schedule, and are quoted in euros for learners in Austria. For current pricing and available dates, request a quote and a learning advisor will share the options that fit you.

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, case-study scenarios and learner support, along with a course completion certificate from Invensis Learning. Ask about the exact inclusions for your chosen format.

Do you offer corporate or group pricing?

Yes. We offer corporate group training with customised schedules and volume-based pricing for development, quality and regulatory teams. Contact us for a tailored quote for your team in Austria.

Are payment or instalment options available?

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

Is the training available in euros for Austrian learners?

Yes. Public and corporate QbD training for learners in Austria is quoted in euros. Request a quote for current fees and upcoming schedules.

Assessment

Is there an exam for the QbD training?

No. Quality by Design training is a non-certification skills course with no examination. Learning is reinforced through hands-on tool exercises, pharmaceutical case studies and team 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 completing the programme. This recognises your participation and is not a certification awarded by an external body.

Is QbD a certification?

No. This is practical, vendor-neutral skills training with no governing body or credential. It builds QbD methodology and tool skills that are immediately applicable to pharmaceutical product and process development.

How is learning assessed during the course?

There is no formal assessment. You apply QbD tools through exercises across the day, building a QTPP, identifying CQAs, running a risk assessment and interpreting a design space using realistic development scenarios.

Will the training help with regulatory submissions?

Yes. You learn to structure QbD evidence, QTPP, risk assessment, DoE results, the design space and the control strategy, for the Pharmaceutical Development section of a CTD submission aligned to ICH expectations.

Course Content

What topics does the QbD training cover?

The course covers QbD principles and the ICH regulatory context, the QTPP and Critical Quality Attributes, risk assessment with Ishikawa and FMEA, Design of Experiments and the design space, Process Analytical Technology and the control strategy, plus QbD case studies and lifecycle management.

Does the course cover Design of Experiments (DoE)?

Yes. You learn screening, response-surface and mixture DoE, how to interpret the statistical models, and how to define a design space with Normal Operating Ranges and Proven Acceptable Ranges.

Is the training relevant to both small molecules and biologics?

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

What hands-on exercises are included?

You practise constructing a QTPP, identifying and classifying CQAs, building an Ishikawa diagram, selecting a DoE design and interpreting a design space, all applied to realistic pharmaceutical development scenarios.

What materials will I receive?

You receive structured courseware covering all QbD modules, tool templates and case-study exercises, plus post-training resources. Materials are aligned to the ICH Q8 to Q11 guidelines.

Enrollment

How do I enrol in the QbD training in Austria?

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

What delivery formats are available?

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

When are the next QbD training sessions?

New public and corporate sessions run regularly for learners in Austria. View upcoming schedules or ask a learning advisor about the next available dates for your preferred format.

Can I reschedule my enrolment?

Yes. Flexible options let you reschedule or transfer to another session on selected plans. Contact support to arrange a change that works for you.

What is the refund or cancellation policy?

Refunds and cancellations follow our published policy, and selected plans include a money-back option. Reach out to our team for the details that apply to your enrolment.