Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.

It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends;  Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why you should attend: Increasingly U.S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF).  In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/B9DD. Being aware of the similarities and differences can further concurrent development and/or updates to both

Areas Covered In the Session:

• The U.S. FDA's DHF
  
• The EU's MDD and the Technical File / Design Dossier
  
• Design Control vs. a Product 'Snapshot in Time'
  
• DHF "Typical" Contents
  
• TF / DD Expected Contents
  
• Parallel Approaches to Documentation -- Teams
  
• Future Directions
  
• FDA and NB Audit Focus

Who will benefit:

• Senior management in Drugs, Devices, Biologics, Dietary Supplements
  
• QA
  
• RA
  
• R&D
  
• Engineering
  
• Production
  
• Operations
  
• Marketing

Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).

Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms? Attend this Webinar to have these questions answered. Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, notfollowing the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming,in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records.

Areas Covered in the Session:

• FDA Quality Systems Regulation Requirements/Definitions
  
• MDD Requirements/Definitions
  
• Design History File (DHF)
• Definition
• Typical contents
• DHF and outsourced design/production
• DHF and OEM relationships
• Device Master Record (DMR)
• Definition
• Typical contents
• DMR and outsourced design/production
• DMR and OEM relationships
• Controlling and maintaining DMR
• Device History Record (DHR)
• Definition
• Contents
• Using DHR data for tracking and trending
• DHR and outsourced design/production
• DHR and OEM relationships
• Technical File (TF)
• Definition
• Contents
• TF and outsourced design/production
• TF and OEM relationship
• Design/process changes and DHF, DMR, DHR, and TF

Who Will Benefit: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes:

• Quality Managers/Engineers
  
• Production/Process Managers/Engineers
  
• Manufacturing Managers/Engineers
  
• QA and QC managers, inspectors, supervisors and personnel
  
• Documentation Specialists
  
• Supplier Quality Managers/Engineers
  
• Regulatory Managers/Engineers

Overview: The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device.

The manufacturer must also compile records of the production history of the device. These two sets of records (DMR & DHR) are complimentary. In addition, the manufacturer maintains two more sets of documents, the Design History File (DHF) and the Quality System Record (QSR). This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA’s thinking, FDA guidance documents for recommendations, and Warning Letters to help participants learn from other firm’s experience. The FDA's QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents.

• The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR).
• The Device Master Record (DMR) contains all the information necessary manufacture, install, service, and maintain the device.
• The Device History Record (DHR) has the objective evidence to support the device production history.
• The Quality System Record (QSR) contains information that is not device specific.

The four sets of documents fit together in a structure that helps assure correct device manufacturing. The content of the documents and the allocation of information depends on your manufacturing system; you should tailor the approach to your company’s products and approaches. This webinar provides the information you need to assure your system is effective and complies with the regulation.

Why should you attend: An FDA inspection will focus on the records you maintain. These records provide the objective evidence that demonstrates your QMS operates the way it should. While procedures are important, the supporting records demonstrate that you follow your own procedures. Much of the evidence is in the four records we discuss in the webinar. If you determine what you keep in each record and then follow your decision, you will have the evidence that you need. Moreover, a well organized set of records will help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action. Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

• Can you list the kinds of records that belong in the Design History File (DHF)?
• Can your team relate the component specifications in the DMR to the Purchasing Data you use to obtain the components?
• Does your team know the records you must keep when you verify the component at receiving?
• Does you team know which of these records must go into the DHR?
• Can your team list the activities that require a designated individual?
• Do you have quality records that designate the individual and demonstrate training to perform the assigned responsibility?
• Can you list the activities and the designated individuals in your company?
• Can your team assure that the designated individual, not somebody else, performed the activity before you released the product for distribution?
• Some information could be in the DMR or the QSR. Does you team know how to make the decision?

Areas covered in the session:

• The FDA's QSR
  
  • The source of the requirements
  • The preamble
  • The QSR Manual
  • OMB information collection
• Key Definitions
  
• Design History File (DHF)
  
  • Requirements
  • Content
• Quality System Record (QSR)
  
• Device Master Record (DMR)
  
  • Contents
  • Linkage to Design Controls
  • Lessons for Implementation
• Device History Record (DHR)
• Contents
• Linkage to the DMR
• Lessons for Implementation

Who will benefit: This seminar is for people involved in project management, design, production, purchasing, installation, servicing, document control, and record keeping activities for medical device manufacturing. People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
  
• Quality Professionals
  
• Regulatory Professionals
  
• Production Managers
  
• Risk Managers
  
• Project Managers
  
• Production Supervisors
  
• Manufacturing Engineers
  
• Production Engineers
  
• Design Engineers
  
• Process Owners
  
• Quality Engineers
  
• Quality Auditors
  
• Document Control Specialists
  
• Record Retention Specialists