Many of our recently held briefings are available on audiocassette files. Visit our Tapes Library for our highly regarded series on:

Audio Library FDA Enforcement: FDA's New Warnings: Bark, Bite ... or Both? Speaker: Daniel Michels of KMI/PAREXEL Date of Briefing: December 17 , 2003 Approximate length: One hour Description: The FDA regulatory pendulum continues to swing, but in what direction? Recent regulatory actions may be signaling a harder enforcement program at FDA, according to compliance expert Daniel Michels of KMI/PAREXEL. “FDA is not issuing as many warnings as in the past,” says Michels, “ but final actions are becoming more severe, particularly financially.” If you or your clients are responsible for responding to FDA-483s, warning letters, or other FDA notices, you need to participate in this informative discussion. Price: $295 CD ttttttttttttt Go to the Order Form Audio Library FDA Enforcement: Preparing Effective Investigative Reports Speakers: C. Russ Rutledge, Senior COPnsultant, AAC Consulting Group (former FDA official) Date of Briefing: September 18, 2003 Approximate length: One hour Description: FDA investigators view reports for out-of-specification (OOS) results, deviations, and batch failures as primary tools for gathering information. They also bring varying degrees of experience to an inspection...and they rely on first impressions. Accordingly, it is incumbent upon the industry to prepare reports that demonstrate control over operations, generate few if any questions, and generally accelerate the inspection process. Our presenter, C. Russ Rutledge -- who wrote the 1998 draft guidance on handling OOS results (that were never finalized) -- says that perceived pressure by regulators is causing many firms to prepare overly detailed standard operating procedures (SOPs). A better alternative is to develop clear, legible failure investigation procedures that specify an orderly sequence, including flow charts and check lists. Price: $275 Tape ttttttttttttt Go to the Order Form Audio Library FDA Enforcement: Understanding REACH Speaker: Ansis M. Helmanis, Barnes, Richardson & Colburn Date of Briefing: August 26, 2003 Approximate length: One hour Description: This presentation covers REACH - "The Regulation, Evaluation, and Authorization of Chemicals" - and why it is important. Our presenter will encourage the drug industry to influence the final version of REACH. Price: $195 Tape ptovvvvv Go to the Order Form Audio Library FDA Enforcement: How Foreign Firms Can Avoid Warning Letters and Import Detentions Speaker: Larry R. Pilot, Esq. Partner, McKenna Long & Aldridge (and former FDA official) Date of Briefing: August 11, 2003 Approximate length: One hour Description: The 30-year history of FDA foreign inspections and issuance of Warning Letters demonstrates what noted food and drug attorney Larry Pilot calls a “remarkable bias” against foreign manufacturers, including those owned and/or managed by U.S.-based companies. The situation regarding device makers, in particular, was revealed three years ago at a EUCOMED conference but little has changed since. As progress is made toward global harmonization, our presenter – a former FDA official and an expert on product importation – makes a strong case for establishing a level playing field for all manufacturers while maintaining the quality and safety implicit in good manufacturing practice (GMP) evaluation. Price: $195 CD ttttttttttttt Go to the Order Form Audio Library FDA Enforcement: Impact of GMP's for Dietary Supplements Speaker: D. Watts Date of Briefing: April 24, 2003 Approximate length: One hour Description: This audiobriefing features a specialist on dietary supplements from the law firm of Sidley, Austin, Brown & Wood. Watts describes the far reaching impact the new FDA rules will have on how dietary supplements are manufactured and packaged. This includes most contractors and foreign suppliers. Price: $195 CD ttttttttttttt Go to the Order Form Audio Library FDA Enforcement: Implement Corporate Coimpliance Programs Speaker: D. Farquhar / J. Fleder Date of Briefing: February 18, 2003 Approximate length: 90 minutes Description: This audiobriefing features two specialists on corporate compliance with FDA regulations. They provide practical information on how to set up effective compliance programs that include training to help staff implement the programs. They also discuss the pros and cons of making voluntary disclosures, the timing of such disclosures, and the person who should make the disclosures. Price: $195 CD ttttttttttttt Go to the Order Form Audio Library FDA Enforcement: How to Respond to FDA 483s and Warning Letters Speaker: W.W. Vodra, Esq. Date of Briefing: December 2, 2002 Approximate length: One hour Description: Vodra, one of the foremost authorities on FDA laws and regulations, provides practical information on what actions to take if you are presented a warning letter or a 483 from the FDA. Price: $195 CD ttttttttttttt Go to the Order Form

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