Date :Wednesday February 13th, 2019
Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States
Type :Conference & Seminar - International audience
Accreditation :--
Further information
Editorial
Objectives
Many firms use some product risk management tools, but are not compliant to ISO 14971, for devices, or ICH Q9, for pharma.
- What changes would be necessary to become compliant?
- What are Europe and U.S. regulatory expectations?
- What benefits beside regulatory compliance can be achieved for a company?
Both the U.S. FDA and the EU's MDD/MDR require companies to be proactive in reducing product risk while increasing user benefits. What "risk" is to be analyzed? One of the best tools to achieve and document this is ISO 14971 for devices or ICH Q9. Both allow leeway in the type of tools used to comply. See the elements recommended or expected to be in the Risk Management File / Report.
Learn how to blend ISO 14971 and ICH Q9. Make the document a "living" document. Achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, increased product safety and reduced liability.
Program
Areas Covered in the Webinar:
- Key requirements of ISO 14971 (2007 and 2012); ICH Q9
- Suggested formats
- Expected sources of information to evaluate
- What to include
- How to complete, document, and control
- An often neglected safety feature
- A "living" useful, cost-saving document
Location
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions
Further information
Announcer
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For more information on Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9, plsase contactr ComplianceOnline
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