Product Risk Management - ISO 14971 and ICH Q9

Instructor: John E Lincoln
Product ID: 701693
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2010

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Read Frequently Asked Questions

In this Product Risk Management webinar learn how to develop and implement product risk management planning. Understand the Key requirements of ISO 14971 and ICH Q9.

Why Should You Attend:
Both the U.S. FDA and the EU's MDD require product risk management as part of virtually all regulatory compliance efforts. Companies must be proactive in reducing product risk while increasing user benefits. Companies are still not developing the required tools nor using them in all regulated / CGMP activities. When used, companies have not provided the documentation to allay investigators' / auditors' concerns. Existing risk documents are not used to their full potential

This webinar will provide valuable guidance to regulated companies in development and implementation of Product Risk Management Planning. It will expand this tool into training, marketing, validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction. Regular use of a few simple but powerful tools in a Product Risk Management File and Report template can contribute greatly to reduction of product liability, company-wide cost reduction efforts, less chance of recalls, and an improved bottom line.

Areas Covered in the Seminar:

  • Key requirements of ISO 14971 and ICH Q9.
  • Suggested formats to meet both FDA and MDD requirements.
  • Expected sources of information for evaluation and inclusion.
  • How to compile.
  • When to involve the team.
  • How to complete, document and control as a 'living' document.
  • An often neglected safety feature.
  • Effectiveness -- Determining and Monitoring.
  • Realizing real cost savings.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in cGMP and MDD/CE-marking compliance. It will discuss and provide examples of ISO- and FDA/D31ICH-compliant product risk management templates. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory affairs
  • Quality Assurance
  • Production
  • R&D and Engineering

Instructor Profile:
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 so+E6ftware 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.

Follow us :
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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.

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