Conformance of Design History Files for Mature Medical Products
Thursday, February 7, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This webinar will provide a step-by-step procedure to all medical device companies that need to bring their product design history files up to date with current standards.
Why Should You Attend:
Many regulated companies have not brought their old products up to current FDA standards and are not in total 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 updated to meet current 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 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 products to meet current 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.
Date: February 07, 2013
Time: 10:00 AM-11:00 AM PST
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
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- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
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- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.