Design Planning, Design History Files and Design Reviews

Design planning, use and maintenance of design history files and periodic design reviews are crucial and integral parts of design control.  All development projects in the medical device space will start with design planning. Without robust planning, it is not possible to keep track of everything that is needed during the development of a medical device. The planning stage and process will lay out and define the tasks needed to complete the development process as well as define subordinate plans to keep track of related activities such as regulatory or production plans.  Proper use and application of the design history file is not only required but essential in documenting the development process. All records related to the development of a product are stored in the design history file and as such, it must be organized, accessible, searchable and secure.   Finally, design reviews are key to track the progress of a design project and a way for management to be formally updated as to where the project stands in relation to goals and what management can do to help if there are delays or setbacks. Design reviews also serve to allow management to approve at key milestones and final product release.

Why You Should Attend:

This webinar delves into the critical aspects of designing medical devices, emphasizing meticulous planning, comprehensive documentation, and rigorous review processes. Participants will gain insights into the regulatory requirements, best practices, and strategies essential for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. The session will explore the significance of Design History Files (DHF) as comprehensive records of the design process, covering design inputs, outputs, verification, validation, and changes. Additionally, it will highlight the pivotal role of design reviews in identifying potential issues, assessing risks, and enhancing the overall design process. By addressing key challenges and providing practical guidance, this webinar equips participants with the knowledge and tools necessary to navigate the complex landscape of medical device design effectively.

Attending this webinar is crucial for professionals involved in the medical device industry to stay abreast of regulatory requirements and industry best practices. By participating, you will gain valuable insights into the intricacies of medical device design planning, DHF management, and design review processes. This knowledge is indispensable for ensuring compliance, mitigating risks, and delivering safe and effective medical devices to the market. Whether you are a regulatory affairs specialist, design engineer, quality assurance professional, or involved in product development, this webinar provides a comprehensive understanding of the essential elements required for successful medical device design and regulatory submissions. Join us to enhance your skills, streamline your processes, and contribute to the advancement of healthcare technology.

Learning Objectives:

• Regulatory requirements for medical device design planning
• Importance and components of Design History Files (DHF)
• Documentation strategies for design inputs, outputs, verification, and validation
• Change control and management in the design process
• Role and significance of design reviews in ensuring product quality and safety
• Risk assessment methodologies in medical device design
• Best practices for conducting effective design reviews
• Case studies and examples illustrating key concepts and challenges

Areas Covered in the Session :

• Quick review of design control flow
• Design planning
  • What is it?
  • Why do it?
  • Aspects
• Design History File
  • What is it?
  • Structure
  • Systems
  • Use
• Design Reviews
  • Why
  • What
  • How many
  • Who

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Product Development Professionals
• Design Engineers
• Compliance Departments
• Clinical Affairs Professionals

Course Director: Alan M. Golden

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.