Compliance Trainings, Online
2016-04-27
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
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