FDA Regulatory Actions: It's Not Just about Warning Letters

Why Should You Attend:

It is important for pharmaceutical and medical device manufacturers and their employees to understand the full scope of regulatory actions available to the FDA as tools to bring non-compliant companies into compliance with all applicable FDA laws and regulations. Being aware of this enables individuals at all levels in the firm to know what is at stake for themselves and their company.

This webinar will provide participants with a basic understanding of how non-compliant activity can affect their company and, closer to home, themselves. While the agency has always been vigilant in taking necessary regulatory actions, it has become increasingly aggressive in the recent past in enforcing the provisions of the FD and C Act. The FDA has imposed civil penalties, huge monetary disgorgement and restitution fines, and invoked its Application Integrity Policy where fraud has been committed. The agency also has, when necessary, seized products, enjoined firms/individuals, and criminally prosecuted companies and individuals.

This webinar will provide firms and potentially responsible and vulnerable employees with an outline of the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues.

Areas Covered in the Webinar:

• Applicable Statutes
• Strict Liability Concept
• Adulteration, Misbranding, Unapproved Products
• Prohibited Acts
• Prior Warning
• FDA-483s
• Advisory Actions, Administrative Actions (civil money penalties, ANDA withdrawals, administrative detentions) and Judicial Actions (seizures, injunctions, criminal prosecutions)
• Recalls
• Imports

Who Will Benefit:

This webinar will provide valuable assistance to all personnel involved in production and quality control activities in pharmaceutical and the medical devices sector, with particular importance to middle and top management/corporate officials.

• Regulatory Affairs Professionals
• Product Managers
• QA staff and management
• QC staff and management
• Compliance auditors
• Plant engineers and management
• Consultants
• Scientists
• Research Analysts
• Foreign Manufacturers
• Importers
• Labelers
• Distributors

Instructor Profile:

Fred Richman’s, background, expertise and extensive knowledge of the U.S. Food and Drug Administration (FDA) has permitted the clients of his firm, Compliance Achievers LLC (www.complianceachievers.com), to become compliant with drug GMP regulations, assisting them in interacting with FDA during compliance inspections, preparing comprehensive responses to FDA’s FD-483 observations, and in attending regulatory meetings with FDA. In his work, Mr. Richman reviews and advises firms on applicable ICH and FDA guidance documents and GMP regulations regarding quality systems, stability data, process validation, and laboratory controls. He routinely provides assistance on import-export issues.

After having served in FDA field positions of Investigator and Compliance Officer, Mr. Richman began his FDA headquarters career as a Senior Case Review Officer in FDA’s Office of Enforcement, where he was responsible for reviewing and clearing for the Office of the Commissioner, legal action recommendations submitted by FDA field offices nationwide. In 1996, Mr. Richman took on the position of Team Leader for the Adverse Drug Reaction and Pharmacy Compounding Team in FDA’s Center for Drug Evaluation and Research (CDER). In his subsequent CDER position as Deputy Director, Division of New Drugs and Labeling Compliance, he supervised regulatory operations relating to Rx and OTC drugs. He was instrumental in developing a regulatory strategy to address the marketing of unapproved drug products. In 2005, Mr. Richman became the Director of the Division of Compliance Management and Operations (DCMO) in FDA’s Office of Enforcement, providing oversight for the review and clearance of proposed legal actions submitted by field offices, supervising the review and preparation of regulatory actions to address violations disclosed during Team Biologics inspections, and overseeing the nationwide activities of field office recall coordinators. His Division also assisted field Compliance Branches in developing regulatory strategies to address specific violative situations.

Mr. Richman has made numerous presentations to groups such as the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA), the Pharmaceutical Education Research Institute (PERI), and the Food and Drug Law Institute (FDLI) on diverse drug and device compliance issues. Mr. Richman was recently selected by the Food and Drug Law Institute (FDLI) to serve on its new Global Committee. This committee is charged with assisting FDLI staff in developing and delivering international educational conferences and publications. For the past year, Mr. Richman has also served as Senior Advisor for Pharmaceuticals and Medical Devices for the Transnational Strategy Group LLC, a Washington, D.C. based international trade and business development firm.

Mr. Richman obtained a B.A. degree in Chemistry from Queens College of the City University of New York, Flushing, New York, and an M.S. degree in Chemistry from St. John’s University, Jamaica, New York.

Topic Background:

Most people in the pharmaceuticals and medical devices industries are aware that FDA investigators often issue form FDA-483s at the conclusion of an inspection and that, if deficiencies are not adequately and promptly corrected, a Warning Letter might be sent by FDA to the top management of a firm. But it is also important for employees, including middle and top level management, to be aware of all of the various advisory, administrative, and judicial sanctions that the FDA can use to prevent continuing non-compliant activity and even punish firms and responsible individuals (which includes top corporate officials) whose actions or inactions have resulted in violations of the Federal Food, Drug, and Cosmetic Act.

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