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.
Many regulated companies have not brought their old products up to the new FDA standards and are not in compliance. Medical products for example should be compliant to 14971:2007 vs. 1497:2000. 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 plan, risk file and a risk report; not just a risk analysis. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.
Areas Covered in the seminar:
- What procedures need to be complete for design history file of an old product to meet the new standards.
- Multi-functional team approach/responsibility.
- Single function approach/responsibility.
- Gathering of data to build the design history files.
- Risk plan, risk file and risk report.
- 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
- 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 project management and product transfers of medical devices, surgical instruments and drug delivery systems. The firm also assesses design control, due diligence and emerging technologies for management evaluation and remediation. Rob develops cutting edge prototype/ product development business models for pull through business for increased profit and growth. Rob has published many articles on Product Development and Leadership.
