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How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances - Webinar (Recorded)

  • Webinar

  • 120 Minutes
  • November 2019
  • Compliance Online
  • ID: 4899933
Why Should You Attend:

Understanding DEA record-keeping and security requirements will help with preparing your company for that DEA inspection. Knowing DEA record-keeping and security regulations is important and what to expect from your employees is essential to avoid the negative impacts on the reputation of your company.

The presentation will cover elements of a DEA inspection and all the stringent record-keeping and security requirements that are expected from a manufacturer. It will provide you with a better understanding of the inspection process. Knowing what is required of a DEA registered Manufacturer will help in preparing for that unannounced DEA inspection.

Areas Covered in the Webinar:

DEA office of diversion control – familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances.
Civil actions – Provides a better understanding of DEA regulations pertaining to the handling of those substances and what specific violations can result in civil actions against a DEA registrant.
Administrative actions – Provides an insight into the administrative actions that results from violations of stringent DEA regulations imposed on manufacturers and distributors of controlled substances.
DEA computation chart – Understanding how DEA performs the audit process is important in order for the registrant to know what is expected from employees.
Record-keeping requirements – Covers records required by DEA during any unannounced inspection. Records include: biennial inventory, order forms, invoices, quota letters, ARCOS reports, thefts & drugs, power of attorney, and drug destructions.
Security requirements – Covers stringent security requirements to prevent the diversion of any controlled substance.
DEA “know your customers” policy – Covers responsibilities placed on DEA registrant when distributing controlled substances.
Sending documents to DEA – Learn the methodology and requirements for mailing documents to the local DEA office.

Speakers

Carlos M. Aquino, Compliance Consultant & Founder, PharmaDiversion LLC . In January 2009, Carlos M. Aquino founded PharmaDiversion, LLC as a compliance consulting firm assisting DEA registrants, who handle controlled substances and regulated chemicals, with compliance of federal laws and regulations that are enforced by DEA through the Office of Diversion Control. This is done through a “Mock” audit and inspection equivalent to a DEA Diversion on-site inspection. The firm also provides in-service training on various areas pertaining to compliance with federal laws and DEA regulations for handling controlled substances.

Consultant Carlos M. Aquino brings 36 years of experience on handling illicit and pharmaceutical controlled substances and regulated chemicals. This includes 12 years with the Philadelphia DEA Diversion and 24 years with the Philadelphia Police Department. During the last 10 years, he was assigned to the Philadelphia DEA Task Force as a street supervisor, undercover agent and case agent investigating the distribution of illicit drugs and the diversion of pharmaceutical drugs.