How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

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Last Recorded Date: Dec-2021

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(PPT + Recorded Training File)

$399.00
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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.
Who Will Benefit:

Corporate members and regulatory compliance personnel of DEA registered manufacturers of controlled substances.

Instructor Profile:
Carlos M. Aquino Carlos M. Aquino

Consultant, PharmaDiversion, LLC

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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