Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing

Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing is a webinar dedicated to Incorporating a strong quality system during pharmaceutical drugs.

Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing covers topics such as:

  • Major considerations in the regulatory requirements for product design
  • Unique product design and development requirements
  • Simplifying the planning and execution phase of your product
  • Insight into the GMP regulations
  • Emerging medical device and pharma development
  • Quality System requirements for your Design Control System
  • 21 CFR 820, 210/211 and ISO 13485
  • Design Control and manufacturing requirements per ICH Guidelines
  • Risk-based Assessment
  • Currently available FDA Guidance Documents
  • Solid identification and documentation of root cause
  • Essential component of a well-documented quality system
  • Proof of evidence needed by regulators
  • What data should you gather for each stage of product development
  • How to sustain the life cycle of your medical product

Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing is intended for:

  • Process Engineering Departments
  • Manufacturing Departments
  • Design Assurance Departments
  • Research and Development Departments
  • Quality Control Departments
  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Document Control Departments
  • QbD Consultants

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