This Medical device training 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 the new standards.
Why Should You Attend:
Many regulated companies have not brought their old products up to the new FDA standards and are not in compliance. This webinar defines the criteria to be used for medical products design history file remediation.
For example companies should be compliant to 14971:2007. Design History Files need to be adjusted to meet the new standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product. 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 date with the new standards.
Areas Covered in the Seminar:
- Multi-functional team approach/responsibility.
- Set procedures and template to complete remediation for design history file of old products to meet the new standards.
- Gap analysis.
- Gathering of data to build the design history files.
- Risk procedure.
- Risk assessment for prioritizing remediation.
- Traceability matrix.
- Validations.
- Dealing with the FDA.
- 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 the new standards. The employees who will benefit include:
- End-users responsible for design control and technical files that need to be updated to the new standards
- R&D and product development engineers and managers
- Remediation teams
- QA, Regulatory Affairs and team members who contribute to design history or technical files
- Validation specialists
- Consultants
- Corporate auditors
Instructor Profile:
Rob Braido, is the founder and principle of Visionary Consulting LLC, a consulting firm that specializes in gap analysis and due diligence for management evaluation of product design and emerging technology acquisition. Visionary Consulting also specializes in the project management of equipment and product transfers in the medical device and surgical instrument market.
Mr. Braido develops cutting edge prototype/product development business models for pull through business for increased profit and growth. Rob is a frequent conference speaker and has published many articles on Medical Product Development and Leadership.
