Archives -- FDA Compliance & Enforcement


Author, “How Data Integrity Issues Sunk a $4.3 Billion Drug Company Acquisition – Lessons Not Just for Quality Professionals, But Also Their Top Management. Legal Letter from America. GMP Review,.  October  2018. Volume 17, No. 3, pp. 18-20.   

Collateral Consequences of Violating the Federal Food, Drug, and Cosmetic Act.  Chapter 15, Pharmaceutical Compliance and Enforcement Answer Book.  The Practicing Law Institute (PLI).  June 2018.    

    • To see outline of Chapter 15, click here.  

    •  For ordering information, click here.

“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.  August 8, 2012.

Presentations & Panel Discussions

Critical Legal Issues Facing GMP Compliance.  23rd Annual GMP By The Sea Conference.  August 27, 2018.  Cambridge, MD.

FDA Inspections: Handling the Consequences -- Understanding How Ugly It Can Get. MAGI's Clinical Research Conference. May 20-23, 2018.  Arlington, VA.  

The Application Integrity Policy (AIP):  A Little History.   Webinar presentation sponsored by Food & Drug Law Institute (FDLI). March 13, 2018.

The Application Integrity Policy (AIP):   A Little History.    Presentation to the Food & Drug Law Institute Annual Enforcement, Litigation & Compliance Conference for the Drug, Device, Food,  and Tobacco Industries. December 5, 2017.  Washington, D.C.

The Sunshine Act:  Understanding the Essentials of Compliance.  Tutorial. Drug Information Association (DIA) Annual Meeting. June 26, 2016.  Philadelphia.

Successfully Responding to FDA Inspections (483s) and Warning Letters. A Compliance2Go Webinar. November 10, 2015.   

FDA Trends in Medical Device Compliance.  Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference.  December 11, 2014.  Washington, D.C.

Labeling/Advertising and Promotion, Import/Export, and Enforcement Actions. Regulatory Affairs Certification (RAC) Review Course. OCRA.  August 2, 2014.  Irvine, CA. 

Understanding The Sunshine Act.  Tutorial. Drug Information Association (DIA) Annual Meeting. June 2014. Washington, D.C.

FDA Warning Letters:  Key Legal and Tactical Issues in Dealing with FDA's "Shot Across Your Bow." Duane Morris Webinar.  April 30, 2014.

FDA Enforcement.  DIA Annual Conference.  Tutorial.  June 23, 2013. Boston.  [same workshop given annually since 2002]

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

Responding to 483's and Warning Letters.  FxConferences Audio Conference.  July 10, 2012. 

"How Do You Look in Stripes?" -- Understanding and Managing the Potential for Liability for FDA-Regulated Companies and Their Officials.   Joint FDA/Orange County Regulatory Affairs (OCRA) Annual Conference. June 7, 2012.  Irvine, CA.

Preparing for Increased FDA Enforcement Activities In Clinical Trials Arena.  FxConferences Audio Conference. November 3, 2011. [no slides]

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: The Cop is Back – How Enhanced Enforcement Can Impact You and Your Firm.  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.

FDA Enforcement.  FDA & California Audit Preparedness.  A SoCalBio Regulatory Workshop.  December 3, 2009.  Irvine, CA.

FDA Enforcement -- the Perils of Inadequate Compliance.  Amylin Pharmaceuticals In-House Lecture. December 1, 2009, San Diego.

FDA Inspections: Handling the Consequences -- Dealing with the aftermath of an FDA Inspection. MAGI West Coast Clinical Trials Conference.  October 6, 2009, San Diego.

FDA’s New Strategy on Enforcement: The Growing Perils of Inadequate Compliance.  Webinar.  The Weinberg Group.  September 9, 2009.

FDA Enforcement – Trends, Powers and Penalties Or “Why Crime Does Not Pay”.  SoCalBio FDA Audit Preparedness Workshop. SoCalBio.  June 12, 2009, Irvine, CA.

The Collateral Consequences of Violating the Federal Food, Drug, and Cosmetic Act…Or “Why Crime Does Not Pay."  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.

Overview of a Recall of an FDA-Regulated Product.  Products Liability for FDA-Regulated Firms sponsored by FDLI, January 26-27, 2005, Washington, DC.

Sarbanes-Oxley – Challenges for FDA-Regulated Companies.  SDRAN, January 2005, San Diego, CA.

Pharmaceutical Legal and Financial Consequences -- When Risk Management Goes Astray. Pharmaceutical Education and Research Institute (PERI).  "Developing a Risk Management Strategy:  A Hands-On Workshop." November 11, 2004.  Washington, D.C. 

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

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