The Most Serious FDA 483s - How to Avoid Them

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

Recorded Version Only

(PPT + Recorded Streaming Link)

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

CD or USB Drive Only

(PPT + Recorded Training File)

$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
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

Follow us:
Areas Covered in the Webinar:
  • Recent Most Serious FDA 483s
  • The "Whys"
  • Root Causes
  • Avoid complacency from past "good" FDA audits.
  • Shifting focus
  • Maximize scarce resources
  • The "risk-based" phased approach
  • Maintain "the edge" -- fight "entropy"
Who Will Benefit:

This webinar applies to personnel/ companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceutical and Biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering

All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the complaing handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking, use or regulated medical products.

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.

Topic Background:

There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits, and the resulting FDA Form 483 Observations. This change in focus has a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to major publicized product failures / recalls, leading to public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. This affects the Agency's approach to audits and their expectations for companies.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

You Recently Viewed