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Ref : 28867
Event :Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9

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

In this product risk management webinar attendees will understand the key requirements of ISO 14971 (2007 and 2012) and ICH Q9. Also attendees will learn how to develop and implement product risk management planning through ISO 14971 & ICH Q9 to increase the product safety and reduced liability. 

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

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9 Hospital
product risk management compliance training, medical device risk management regulatory requirements, risk management training, risk compliance training, fda requirements, eu mdd requirements, medical device compliance training, pharmaceutical risk management
Professionals, Senior management Regulatory Affairs Quality Assurance Production Engineering Sales and Marketing All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD-regulated environment.
10 -- --
English

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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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