Faculty: Susanne Manz


  • Date: 6/2/2022 01:00 PM - 6/2/2022 04:00 PM
  • Location: Online Event

Tickets


Ticket Type
Qty
Live- Single
$392.00
0
For ONE Participant – Live session only
Live Corporate
$1083.00
0
For Maximum of 10 participants – Live session only
Recording - Single
$598.00
0
Recording access for ONE participant (viewer) – Unlimited viewing access for 6 months
Recording - Corporate
$1894.00
0
Recording access (Multiple licenses) for up to 10 participants – Unlimited viewing access for 6 months

Total

$0.00

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. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.

Why You Should Attend:

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 seamlessly incorporate design control into your product development process. In this webinar you’ll hear from an industry expert on how to create an effective, efficient, and compliant design control process.

Learning Objectives:

  • 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

Seminar Agenda:

  • Overview and Definitions
  • FDA Expectations, Regulations
  • Design Control Process
  • Design and Development Planning
  • Design Inputs
  • Design Outputs
  • Verification
  • Validation
  • Risk Analysis (Management)
  • 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 Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Engineering Departments
  • Regulatory Affairs Departments
  • Product Development Managers
  • Product Development Project Leaders
  • Individuals participating in Product Design and Development
  • Individuals Participating in Design Changes and Failure Investigations
  • CAPA Specialists
  • Compliance Specialists
  • Auditors
  • Senior Management