This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are considering the need to bring their product design history files up to date with the current standards.
For example, companies should be compliant to ISO 13485:2003, ISO 14971:2007, 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 product needs to have a gap analysis to determine obsolescence or 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.
Why Should You Attend:
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 befollowed for medical products design history file remediation.For example, companies should be compliant to ISO 13485:2003, ISO 14971:2007, 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 product needs to have a gap analysis to determine obsolescence or 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 Seminar:
- 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:- End-users responsible for design control and technical files that need to be updated to the current standards
- Medical device R&D and product development
- Medical device Process engineers and managers
- Operations and plant management
- Validation engineers
- Remediation teams
- Medical device 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
Course Provider
Rob Braido,
