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Understanding and Implementing a Quality by Design Program

Steven Laurenz Instructor:
Steven Laurenz 
Wednesday, May 14, 2025
12:00 PM PDT | 03:00 PM EDT
60 Minutes
Webinar ID: 502940

More Trainings by this Expert

Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview:

This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization.

Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application.

Why you should Attend:
The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use.”

Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.

Areas Covered in the Session:

  • Quality Target Product Profile (QTPP)
  • Risk Assessment
  • Using Models
  • Design of Experiments
  • Developing a Design Space
  • Process Analytical Technology (PAT)
  • FMEA and Control Plan
  • Target Operational Profile
  • Control Strategy

Who Will Benefit:
  • Senior Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Development Professionals
  • Senior Development Managers


Speaker Profile
Steven Laurenz Chemical Engineering M.S. - Michigan State University Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization.

Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.

Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium.

Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics


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