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Subscribe NewsletterDesign History Files: Their Content and Control
Product Id
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600047
Overview: After attending this presentation the attendee should come away with a good knowledge of what the requirements for Design History Files are from both a domestic and international perspective, how to minimize DHF content so that the requirements are still
No matter what you are designing and no matter what your industry, if your organization is certified to an international standard such as ISO13485 or ISO9001 you are required to establish and maintain a Design History File for all of your products. The ability for your organization to provide objective evidence that you not only have met the Design Control requirements or regulation but that you can also provide the documentation required is imperative when subjected to investigation or audit activity, whether internal or external in nature. Whether using a large file cabinet full of paper or an electronic documentation system such as a Product Lifecycle Management System, this presentation entitled: “Design History Files: Their Content and Control” will provide you with an insight as to what you need in your Design History File (DHF).
In a regulated industry such as Medical Devices the FDA requires compliance to 21 CFR Part 820.30: Design Controls, while maintaining certification to the ISO9001 and ISO13485 requirements for Product Realization these standards also has similar requirements. During this one hour webinar the presenter will review what needs to be in your design history file, such as design input documents, design review documents, design output documents and design change documentation. Also what should not be in your design history file such as Complaints or Corrective and Preventive Action (CAPA) activity associated with a particular product. Further details regarding the associated documents related to the Complaint or CAPA activities will be included in this presentation. Additionally the presenter will discuss where Operational Documents fit into the Design History File.
The European Union’s Medical Device Directive (MDD) 93/42/EEC Technical file requirements for Medical Devices have similar content to the FDA and ISO13485 Design History File requirements. The presenter will discuss how these documents differ and where the overlaps take place. From Design Concept to Product Obsolescence, the Design History File must be a “living document” with “File” not necessarily meaning that this information be housed all in the same place. The FDA Quality System Regulation requirements for Device Master Record requirements will also be discussed as this has significant impact on your DHF content.
No matter what you are designing and no matter what your industry, if your organization is certified to an international standard such as ISO13485 or ISO9001 you are required to establish and maintain a Design History File for all of your products. The ability for your organization to provide objective evidence that you not only have met the Design Control requirements or regulation but that you can also provide the documentation required is imperative when subjected to investigation or audit activity, whether internal or external in nature. Whether using a large file cabinet full of paper or an electronic documentation system such as a Product Lifecycle Management System, this presentation entitled: “Design History Files: Their Content and Control” will provide you with an insight as to what you need in your Design History File (DHF).
In a regulated industry such as Medical Devices the FDA requires compliance to 21 CFR Part 820.30: Design Controls, while maintaining certification to the ISO9001 and ISO13485 requirements for Product Realization these standards also has similar requirements. During this one hour webinar the presenter will review what needs to be in your design history file, such as design input documents, design review documents, design output documents and design change documentation. Also what should not be in your design history file such as Complaints or Corrective and Preventive Action (CAPA) activity associated with a particular product. Further details regarding the associated documents related to the Complaint or CAPA activities will be included in this presentation. Additionally the presenter will discuss where Operational Documents fit into the Design History File.
The European Union’s Medical Device Directive (MDD) 93/42/EEC Technical file requirements for Medical Devices have similar content to the FDA and ISO13485 Design History File requirements. The presenter will discuss how these documents differ and where the overlaps take place. From Design Concept to Product Obsolescence, the Design History File must be a “living document” with “File” not necessarily meaning that this information be housed all in the same place. The FDA Quality System Regulation requirements for Device Master Record requirements will also be discussed as this has significant impact on your DHF content.
Areas Covered in the Session:
- Basic Overview Of 21 CFR Part 820.30 Design Control Requirements
- Concentration on Design History Files Including:
- What Needs to be in the DHF
- What Should Not Be in The DHF
- How Operational Documentation Fit in the DHF
- Making your DHF Auditable
- Relationship to the Technical File Requirement of the MDD
Who Will Benefit:
- Design Engineers
- Quality Assurance Personnel
- Program Managers
- Manufacturing Engineers
- Regulatory Personnel
- Engineering Managers