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

Description :

Incorporating a strong quality system during pharmaceutical drugs and medical device design and development by understanding the unique product design and development requirements for final approval and marketing of medical devices and pharmaceuticals through global regulating bodies such as US FDA.

Large and small medical device and pharmaceutical companies have a challenge in dealing with initial stages of a successful product development, specifically in performing a timely, unbiased, scientifically sound documentation of early stages of their discovery. Verification, Validation and Testing after designing their product incorporating quality at each stage of design is a regulatory requirement.

This webinar will pave a solid path to those who want to ensure making their QbD (Quality by Design) the strongest link in their quality system and see their product launched successfully in the market for patients.

Areas Covered in the Session :

Unique product design and development requirements

Major considerations in the regulatory requirements for product design

Insight into the GMP regulations

Simplifying the planning and execution phase of your product

Quality System requirements for your Design Control System

Emerging medical device and pharma development

Design Control and manufacturing requirements per ICH Guidelines

21 CFR 820, 210/211 and ISO 13485

Currently available FDA Guidance Documents

Risk-based Assessment

Essential component of a well-documented quality system

Solid identification and documentation of root cause

What data should you gather for each stage of product development

Proof of evidence needed by regulators

How to sustain the life cycle of your medical product

Who Will Benefit:

Manufacturing Departments

Process Engineering Departments

Research and Development Departments

Design Assurance Departments

Quality Assurance Departments

Quality Control Departments

Document Control Departments

Regulatory Affairs Departments

QbD Consultants