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Webinar On - Conformance of Design History Files for Mature Medical Devices


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Webinar On - Conformance of Design History Files for Mature Medical Devices


Scheduled On : Wednesday, March 12, 2014 at 13:00 Hrs

Description :

This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are in need of bring their product design history files up to date with the current standards.

Many medical industry companies have not brought their old product lines up to current FDA standards and are not in total compliance. This webinar defines the procedures to be followed for medical products design history file remediation.

For example, companies should be compliant to ISO 13485, ISO 14971, etc. Design History Files and validations need to be updated to meet current standards. The FDA expects continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each device needs to have a gap analysis to determine obsolescence or re-validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

In this webinar, we will discuss practical steps you can follow to bring your product design history files up to current standards.

Areas Covered in the Session :

  • Multi-functional team approach/responsibility.
  • Set procedures and template to complete remediation for design history file of old devices to meet current standards.
  • Gap analysis
  • Data gathering to build the design history files
  • Risk procedure
  • Risk assessment for prioritizing remediation
  • Validations
  • Dealing with the FDA
  • Phase by phase check list.

Who Will Benefit:

This webinar will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with current standards. The employees who will benefit include:

  • Senior management
  • End-users responsible for design control and technical files that need to be updated to the current standards
  • R&D and product development
  • Process engineers and managers
  • Operations and plant management
  • Validation engineers
  • Remediation teams
  • Documentation teams
  • QA, Regulatory Affairs
  • QC and Corporate Auditors
  • All team members who contribute to design history, clinical, validations or technical files
  • Consultants
  • All Contract Manufacturers working in the medical industry




Webinar On - Conformance of Design History Files for Mature Medical Devices

Source: Press Release



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