ACI’s Legal, Quality, Regulatory, and Compliance Forum on Current Good Manufacturing Practices

November 19, 2013

The American Conference Institute will be holding its inaugural forum on
current Good Manufacturing Practices (“cGMPs”) in Washington, D.C. from Thursday, January 23 to Friday, January 24, 2014.  A copy of the conference program can be obtained here.  Hyman, Phelps & McNamara, P.C.’s Douglas B. Farquhar will be presenting at the conference in a session titled “International Inspections: Preparing For Inspection of Overseas Manufacturing Facilities by FDA and Comparable Foreign Regulatory Authorities.”

The conference will include presentations from regulatory and legal experts on myriad topics, including presentations from several key government officials.  Howard R. Sklamberg, Director of FDA’s Office of Compliance in the Center for Drug Evaluation and Research, will discuss the Agency’s “Case for Quality” Initiative.   Annamarie Kempic, Deputy Chief Counsel for Litigation in FDA’s Office of Chief Counsel, will discuss cGMP Complaints, Consent Decrees, and Corporate Integrity Agreements.  In addition, Jeffrey Steger, the Assistant Director in the Consumer Protection Branch, Civil Division of the U.S. Department of Justice, will give a rundown of notable cGMP actions.

FDA Law Blog is a conference media partner.  As such, we can offer FDA Law Blog readers a special $200 discount off the current price tier.  The discount code is: FLB200.  We look forward to seeing you at the conference.

Categories: Enforcement