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Understanding And Implementing A Quality By Design (Qbd) Program - Webinar

  • Webinar
  • 1 Hour
  • 5 December 2022 13:00 EST
  • Compliance Trainings
  • ID: 5574858
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.

Agenda

  • 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 Should Attend

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