3-hr webinar:Design Controls for Medical Devices
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar
"Hear By Susanne Manz who holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality."
Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.
Description
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 3-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
Mistakes made during the design phase can cause customer dissatisfaction, compliance issues, or even harm your customers leading to MDRs and even recalls. These mistakes are sometimes difficult to correct later in the product lifecycle. It is important to understand and efficiently/effectively incorporate design control into your product development process. In this webinar you’ll hear from an industry expert on how to create an effective, compliant design control process.
Course Objective:
- Understand regulations and expectations
- Review enforcement case studies for lessons learned
- Understand the Design Control Process
- Use of Risk Assessment/Management Techniques
- Identify Best Practices
- Prepare a Plan for Inspection Readiness
Areas Covered
In this webinar, we will cover:
- Overview and Definitions
- FDA Expectations, Regulations
- Design Control Process
- Planning
- Design Inputs
- Design Outputs
- Verification
- Validation
- Design Review
- Design Transfer
- Design Changes
- Design History File
- Linkages to other Quality System Requirements
- Lessons Learned and Enforcement Case Studies
- Best Practices
- Preparing for an FDA or NB Inspection
Who will Benefit
- R&D Engineers and Scientists
- R&D Managers and Directors
- Individuals participating in Product Design and Development
- Individuals participating in design changes and failure investigations
- Regulatory Affairs
- Design Quality Engineers
- CAPA Specialists
- Compliance Specialists
- Auditors
- Senior Management
Industries who can attend
This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel