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Understanding and Implementing a Quality by Design (QbD) Program

This course equips pharmaceutical development professionals to apply Quality by Design principles in practical development environments, improving process understanding, risk-based decision making, and manufacturing consistency. It supports stronger alignment between product quality objectives, development rationale, and operational execution. This Course is designed for professionals involved in pharmaceutical development, process improvement, quality systems, and manufacturing consistency initiatives.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Steven Laurenz
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2309
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Quality by Design has become an important approach for improving pharmaceutical development efficiency, product understanding, and manufacturing consistency. Effective implementation requires more than familiarity with terminology; it depends on the ability to connect development knowledge, process understanding, risk assessment, and control strategy into a practical operating model. Organizations often face challenges integrating these concepts across development functions, particularly when balancing innovation, process reliability, and product quality expectations.


This TalkFDA Live webinar explains the core principles behind a QbD approach and their application within pharmaceutical development organizations. The program addresses Quality Target Product Profile development, risk assessment methods, design space establishment, process analytical technology, and control planning. It also examines the use of models and design of experiments to support process understanding and decision-making throughout development and manufacturing activities.

  • Strengthen Development and Process Decision-Making:

    Participants will gain practical understanding of how QbD principles connect formulation knowledge, process understanding, and risk evaluation during pharmaceutical development. The course clarifies how tools such as design of experiments, modeling, and design space development support more informed technical decisions while reducing uncertainty during technology transfer and manufacturing scale-up activities.

  • Improve Manufacturing Consistency and Control Planning:

    The course explains how control strategies, FMEA practices, PAT applications, and operational profiles contribute to maintaining product quality throughout manufacturing. Organizations implementing QbD approaches are expected to demonstrate stronger process understanding and documented development rationale, making structured control planning increasingly important for product reliability and operational performance.

Key Areas Covered

  • Quality Target Product Profile (QTPP) development and its role in pharmaceutical product quality planning
  • Risk assessment approaches supporting development decisions and process understanding
  • Use of models and Design of Experiments to evaluate formulation and process variables
  • Establishing a development design space for manufacturing consistency and process control
  • Process Analytical Technology (PAT) applications within Quality by Design programs
  • FMEA, control plans, target operational profiles, and control strategy development

Who Must Attend

  • Quality Departments
  • Regulatory Departments
  • Compliance Departments
  • Production Departments
  • Manufacturing Departments
  • Engineering Departments
  • Process Owners
  • Quality Auditors
  • Development Departments

Quality training, expert insights, and answers that matter. Know your Expert

STEVEN LAURENZ

Steven Laurenz has more than 25 years of experience in pharmaceutical product development, process development, technology transfer, and manufacturing support. His background includes integrating Quality by Design and risk management principles into development organizations and establishing quality systems within R&D environments. He previously led product development departments at Abbott Laboratories and AbbVie Inc. and has held leadership roles in technical consortium activities related to pharmaceutical development and process improvement.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Your TalkFDA Webinar Experience

When you reserve your seat, everything is organized for you — from access to certification from one place.

1. Confirmation
You receive a confirmation email and your course appears instantly in your TalkFDA dashboard.

2. Your Course Hub
Your TalkFDA course page becomes your central hub where you can watch the course, access materials, and manage your learning.

3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

The challenge with training is rarely signing up. It’s what happens afterward, when access, materials, & certification aren’t accessible from one place.
With TalkFDA Courses, Everything you need Live in One Place.
Simple. Organized. Professional.
Go ahead and Take the Course with confidence.

Our students love us ❤️

“Content was put together well. Didn’t feel like random slides. One thing actually led to the next.”

Manager, Quality Assurance
“Pacing was right. Didn’t feel dragged. Didn’t feel rushed either.”


Senior Manager, Operations
“Structure helped. Otherwise this topic can get messy quickly.”


Validation Specialist, QA

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