Quality System Regulations for Devicemakers: A Regulatory Approach 2015 is a webinar that covers topics such as:
- Demonstrate a proactive approach to quality and improve operational efficiency
- Multitude of what regulatory agencies are going to review relative to Quality Systems compliance
- Incorporate risk-management strategy to quality systems application
- Anticipate and meet FDA expectations for a compliant quality system
- Track and organize data efficiently to improve the evaluation process
- Build a quality-focused culture and facilitate management support for quality systems processes
- Integrate risk assessment activities into the product design process to meet expectations of "quality by design
- Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
- Understand the elements of the and how each subsystem is interconnected to the rest in order to meet GMP requirements
- Identify crucial training issues to address job-specific compliance responsibilities
- Evaluate SOPs, design controls, and validation protocols from a quality perspective and make revisions or improvements as needed
- Conduct internal audits to monitor quality and apply corrective actions when appropriate
- Organize and manage evaluation data to improve product quality and address customer complaints
Quality System Regulations for Devicemakers: A Regulatory Approach 2015 is intended for:
- Interdepartmental functions associated with scaling up and commercializing a new medical product
- Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products
- Suppliers and software vendors, servicing the FDA regulated industries, who want to better understand the customer’s needs and requirements
- Regulatory Affairs working on approval of combination products
