The Most Serious FDA 483s - How to Avoid Them
Location: Attend Live Webinar
Date: 03-Mar-2015: 10:00 AM PST
Duration : 90 Mins

Speaker: John E. Lincoln

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.

Course Description:

U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations (21 CFR Part 111, 210/211, and 820).  They are then required to translate those regulations into procedures and work instructions. 

Many companies who are successfully doing that are still failing audits, facing major recall, and multi-million dollar fines.  What company failures contribute to this unnecessary result?  What could / should be done differently?  How do product hazard / risk management under ICH Q9 or ISO 14971 assist this process?  How do companies address these issues now for audits that may be years in the future? 

Listen to an expert who wrote the definitive article on this subject in February 2002 ("Avoiding Warning Letters", MD&DI Magazine) and benefited from resulting industry feedback and utilization to this day.

GMP lapses have resulted in multi-million dollar fines, recalls and lawsuits.  Sadly most could have been easily prevented.

Course Objective:

What are the most frequent 483 observations by industry?  What are the "fixes".  Many industry CGMP 483 observations shouldn't have been received at all.  Most Warning Letters could have been easily prevented. Yet the last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution.  

What can companies do proactively to address these concerns and better ensure better regulatory compliance?  What can they do to eliminate negative audit findings that should never have been written in the first place.  If 483's are received, how can Warning Letters be avoided?  How can a company's positive actions be demonstrated to prevent their real achievements  being short-circuited. 

What can companies do in addressing these issues?  Why is "entropy" a major player? How can a company "put an auditor's mind at ease" before, during and after a CGMP compliance audit? How to address FDA District and Center concerns?  Presented by one who first "wrote the book" on such avoidance techniques in Feb 2002.

Course Outline:

• The "tougher" U. S. FDA and Regulatory “Hot Buttons”

• Recent news headlines -  prominent / respected company failures

• Top 483s by Industry, FDA FY 2013 and FY 2014

• Why do Companies Fail When They Are in Compliance

• Address Problems With an Eye to the Future 

• Reviewing Company Compliance to These Issues

• Filling in the "Gaps"

• Entropy - a major "player"

 Target Audience:

• Senior management in Drugs, Devices, Biologics, Dietary Supplements

• QA

• RA

• R&D

• Engineering

• Production

• Operations

• Consultants; others tasked with product, process, validations, CGMP responsibilities

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To Enroll for This Program today  please click hear

Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com