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

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Recorded Link and Ref. material will be available in My CO Section

Training CD

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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.

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