The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 23, 2015 from 1pm to 2pm
Street: 5939 Candlebrook Ct
Website or Map: https://compliancetrainings.c…
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Jun 22, 2015
The FDA expects companies to perform meaningful, results driven Design Control activities as defined in 21 CFR 820.30, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. A review of recent information from the Agency, including recent Working Group findings and Reports, as well as other goals of the Agency that have already been translated into action in the field in the past several years, provide further direction in areas of concern and what to expect in the future.
Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" / "fast cycle" product development. In addition, growing high-profile field problems indicate that design control and it’s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of the design control process -- the ISO 14971 "model". A growing push by the Agency to strengthen the 510(k) process, and review existing devices with above normal adverse events are additional concerns, to be factored into the design control process.
New “Agile” development methods bring added concerns. The resulting documentation can have other far-reaching uses in a company. Proper design control requires a defined "start" date, and the systematic / SOP-defined implementation of formal methods with documented, and defensible, rationale. When properly executed, it can also be a powerful product development project management tool.
Areas Covered in the Session :
FDA Device Clearance / Changes in Direction
Current Design Control Requirements
Defining the "Start" Date and Its Significance
The 9 Design Control Elements and Their Implementation and Documentation
"Retroactive" Design Control
“Agile” Design Control
The Business Case for Design Control
Interactive Q & A session
Who Will Benefit:
This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
QA / RA
And all personnel involved in verification and/or validation planning, execution and documentation.
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