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Compliance & Enforcement
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Archives -- Compliance & Enforcement
Responding to FDA Warning Letters.  Duane Morris Webinar.  April 30, 2014.

FDA Enforcement.  DIA Annual Conference.  Tutorial.  June 23, 2013.  Boston.

Responding to FDA Inspections & Warning Letters.  Compliance2Go. Webinar.  February 7, 2013.

“D.C. Circuit Affirms HHS Power to Disqualify Corporate Officials Convicted of Misdemeanors Under
the "Responsible Corporate Official" (RCO) Doctrine.”   Client Alert. Duane Morris LLP.

Responding to 483's and Warning Letters.  FxConferences Audio Conference.  July 10, 2012.
FDA Enforcement.  Pre-conference Tutorial at DIA Annual Conference.  June 24, 2012.  Philadelphia.

How Do You Look in Stripes?  FDA Enforcement Today.  Joint FDA/Orange County Regulatory Affairs
(OCRA) Annual Conference.  June 7, 2012.  Irvine, CA.

FDA Enforcement Activities In Clinical Trials Arena.  FxConferences Audio Conference.  November 3,

An Overview of Issued FDA Warning Letters:  What Happened and What Can be Learned.  ExL Pharma’s
2nd Quality Oversight of Clinical Vendors Conference.  October 18, 2011.  Washington, D.C.

FDA Enforcement.  DIA Annual Conference, June 19, 2011, Chicago. [same workshop given annually
since 2002]

FDA Enforcement.  The Weinberg Group Inc. Webinar, December 15, 2010.

FDA Enforcement and Compliance.  Introduction to Medical Device Law.  FDLI.  November 2010, Costa
Mesa, CA.

FDA Enforcement.  Moderator.  RAPS Annual Conference.  October 25, 2010, San Jose, CA. [no slides]

FDA Enforcement.  ACI FDA Enforcement Conference.  May 25, 2010, Philadelphia.

How to Respond to a 483.  SoCalBio FDA Audit Preparedness Workshop. SoCalBio.  December 3, 2009,
Irvine, CA.

FDA Enforcement.  Amylin Pharmaceuticals In-House Lecture.  December 1, 2009, San Diego.

FDA Enforcement.  MAGI West Coast Clinical Trials Conference.  October 6, 2009, San Diego.

Corporate Health Panel.  Orange County Regulatory Affairs (OCRA)/FDA Annual Educational
Conference.  June 9, 2009, Irvine, CA.

Product Recalls:  A Panel Discussion.   3rd Annual Medical Device Quality Congress.  Management
Roundtable and FDANews, May 3,  2006, San Diego.  [panel discussion; no slides]

The Future of Compliance Governance.  FDLI Annual Conference, April 7, 2006, Washington, D.C.

Warning Letters.  Session Moderator at OCRA/FDA Joint Educational Conference,
June 15-16, 2005, Irvine, CA.  [no slides]

Challenges for FDA-Regulated Companies in Addressing Current Corporate Responsibility Trends.  
Workshop on Corporate Responsibility Issues for Regulatory Affairs Professionals.  RAPS West Coast
Conference & Exhibition, March 22-24, 2005, San Francisco, CA.

Recalls by FDA-Regulated Companies.  Products Liability for FDA-Regulated Firms sponsored by FDLI,
January 26-27, 2005, Washington, DC.

Sarbanes-Oxley – Implications for Life Sciences Companies.  SDRAN, January 2005, San Diego, CA.

FDA Enforcement and Compliance. SDRAN, San Diego, October 2003.

What Every Clinical Director Must Know About FDA Regulatory Compliance. DIA Annual Meeting,
Half-Day Workshop, June 2003, San Antonio.
© 2014   Michael A. Swit.  


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Michael A. Swit