FDAnews Announces — Digging for 483 Gold: How to Mine the FDA’s Inspection Reports Webinar, Dec. 8, 2014

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Learn the secrets of deciphering 483s and how to use them to pass inspection. In 30 minutes, Michael Swit, Special Counsel with Duane Morris LLP, will present an information-packed FREE webinar using FDAnews’ exclusive FDA Form 483 database to review various 483s and describe how to read and decipher them.

Digging for 483 Gold:
How to Mine the FDA’s Inspection Reports
**FDAnews Free Webinar**
Dec. 8, 2014 — 1:00 p.m. – 1:30 p.m. EST
http://www.fdanews.com/DiggingFor483Gold

What do gold mines and 483s have in common?

Untapped wealth.

Learn the secrets of deciphering 483s and how to use them to pass inspection.

In 30 minutes, Michael Swit, Special Counsel with Duane Morris LLP, will present an information-packed FREE webinar using FDAnews’ exclusive FDA Form 483 database to review various 483s and describe how to read and decipher them.

Among the many things he’ll teach attendees based on these 483s include:

  •     How to prep for the next inspection by studying the actions of the specific investigator that will be conducting the inspection
  •     Tips for using 483s to keep tabs on the competition — understanding where their compliance weaknesses lie
  •     How 483s can become a crucial part of auditing suppliers and partners
  •     How to study the citation patterns and not become part of the statistics
  •     And much more…

Attend this one-of-a-kind FREE webinar to learn how knowing an investigator’s training and tactics can help identify their current hot buttons.

Who Will Benefit:
Individuals involved in:

  •     RA/QA
  •     GLP/GMP compliance teams
  •     Internal audit teams
  •     R&D
  •     Engineering
  •     Production
  •     Manufacturing
  •     Operations
  •     Senior management
  •     Consultants/lawyers
  •     Others tasked with product, process, equipment responsibilities

Meet the Speaker:
MICHAEL A. SWIT, Special Counsel, Duane Morris LLP
San Diego, CA

Michael A. Swit's practice focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals, food labeling and safety issues, dietary supplement health claims, and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.

Webinar Details:
Digging for 483 Gold:
How to Mine the FDA’s Inspection Reports
**FDAnews Free Webinar**
Dec. 8, 2014 — 1:00 p.m. – 1:30 p.m. EST
http://www.fdanews.com/DiggingFor483Gold

Easy Ways to Register:
Online:     http://www.fdanews.com/DiggingFor483Gold
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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