 | |  | |  | |  | |  | |  | |  |
[To view/download the full text of a presentation or article, just click on the title below.]
Compliance & Enforcement Presentations
| To Jump To Another Page of Our Archives, Just Click on The Subject Button Below ... |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
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.
DIA Annual Meeting, Half-Day Workshop, June 2003, San Antonio.
| For information on our Services relating to FDA Enforcement & Compliance initiatives, just click here ... |
| Speeches & Articles Archives |
FDA Enforcement Activities In Clinical Trials Arena. FxConferences Audio Conference.
November 3, 2011.
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. 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. [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.
November 3, 2011.
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. 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. [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.
| ||||||||||||||||||||||||
|