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

Instructor: John E Lincoln
Product ID: 701693
Training Level: Intermediate to Advanced
  • Duration: 60 Min
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.

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2019

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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., Pharmaceutical, 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.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln 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, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln 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. Mr. Lincoln is a graduate of UCLA.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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