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

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Wednesday - Apr 09, 2014 10:00 AM
  • End Time:
  • Wednesday - Apr 09, 2014 11:00 AM
  • Location:
  • Online
  • This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

    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
    -Advisory Actions, Administrative Actions (civil money penalties, ANDA withdrawals, administrative detentions) and Judicial Actions (seizures, injunctions, criminal prosecutions)

    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
    -Research Analysts
    -Foreign Manufacturers

    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 (, 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.
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