Avoid 'Bet the Company' Decisions with Product Changes and 510(k)s

Instructor: John E Lincoln
Product ID: 701374
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: Jul-2009

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Read Frequently Asked Questions

This 510(k) compliance webinar provide valuable assistance in powerful tools that will assist to make rational and repeatable decisions on when one or a series of product changes reaches the stage where the submission of a new 510(k) is warranted.

Why should you Attend:
Companies worry over when one change is big enough to warrant the time and expense of a new 510(k) filing. They're undecided as to when a series of smaller changes reaches the "tipping point" of requiring a new filing. It’s a difficult decision to weigh then end to file versus the time and expense of doing so, in an increasingly difficult and challenging regulatory climate. A wrong decision can be costly to company finances and personal careers. And the opposite risks of guessing wrong, not filing and having their product taken off the market.

In this enlightened manufacturing age, many companies still rely on "gut feel" to make the costly determination as to when product or process change(s) requires the filing of a new 510(k), Pre-Market Notification, with the FDA. No structure or system exists to allow such decisions to be made rationally, and repeatedly using the same criteria. How can a company develop such a rationale? What is involved in establishing the criteria for responsible decision-making, that can be documented and withstand audit scrutiny? How can a decision not to file be documented in such a way as to withstand audit scrutiny?

Areas Covered in the seminar:

  • The 510(k) Overview: It's purpose.
  • Knowing what the FDA looks for assists in deciding when to file.
  • Who make the decisions.
  • Documenting the "tipping point" and its criteria.
  • The FDA's "Decision Tree" and its use in the company.
  • A standard method for documenting a decision "not to file".
  • A Case Study.
  • Resolving a "wrong decision".
  • "Systematize" the decision-making process.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that needs to replace a "shoot from the hip" decision-making with a repeatable and predicable system in which their in-house personnel can be trained -- logical and powerful decision-making tools that will assist in making rational and repeatable decisions on when one or a series of product changes reaches the stage where the submission of a new 510(k) is warranted. A process that is self-documenting. This applies to companies in the Medical Device, Diagnostic, and Biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering
  • All personnel tasked with change control

Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o 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.

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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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