Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9

John E. Lincoln

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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.

Why Should You Attend:

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.

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

Who Will Benefit:

This webinar will provide valuable assistance to personnel in all regulated companies responsible for cGMP and MDD/MDR/CE-mark compliance. This information applies to primarily to personnel / companies in the Medical Device industry. However, it's principles apply and can be used in other regulated industries, e.g., armaceutical, Diagnostic, Biologics and Dietary Supplements. The employees who will benefit include:

  • 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.
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Training CD-DVD

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Speaker: John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA