Bringing Compliance To Design Control For Older Products
Thursday, November 14, 2013 from 10:00 AM to 11:00 AM (PST)
This webinar will discuss the procedures that medical device companies need to follow 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
- 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
- Corporate auditors
Mr. Braido, has 40 years of experience in the medical industry. He is the founder and president of Visionary Consulting LLC and has 40 years of medical OEM’s and CMOs to the medical industry. A consulting firm that specializes in gap analysis and due diligence for management evaluation of product transfers, acquisitions and emerging technologies.
Mr. Braido’s has a broad breadth of medical industry experience in, product development, global strategic/tactical planning, technical due-diligence/gap analysis for acquisitions, engineering, operations and strong leadership skills to help develop new product concepts for business and marketing. He has had great success working at Ethicon Endo-Surgery a J&J Company, Baxter Healthcare, GW Plastics, Teleflex Medical and The Tech Group with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the SPE (Society of Plastic Engineers) Medical Division for over 10 years and elected Chairman of the Medical Division twice.
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