The Most Serious FDA 483s - How to Avoid them

This 90-minute session will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changed FDA focus based on recent 483 analysis, and their audit "paradigm". Such analysis allows a company to evaluate/ perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. 

John E Lincoln
Instructor:
John E Lincoln
Date:
Tuesday, April 23, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502459

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

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.

Why should you Attend: Recent FDA audits indicate a shift in the top serious Form 483 observations.

This webinar will evaluate the chief areas of FDA CGMP compliance audits based on recent top 483 findings to see actual and anticipated changes in emphasis, and how to better prepare with a company's internal audit program .

This 90-minute session will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changed FDA focus based on recent 483 analysis, and their audit "paradigm". Such analysis allows a company to evaluate/ perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.

Areas Covered in the Session:

  • 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 complaint handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking, use or regulated medical products.


Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.




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