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How to Survive a DEA Inspection Series: For a Research Facility

Name : CarlosM.Aquino Product ID : 800027 Training Options Duration:2Hours
Thursday, December 1, 2011 10:00 AM PST | 01:00 PM EST

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Overview
The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods. Determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment). Determining if an IMP is subject to liver injury separates the best PI's from the rest. Why you should attend: It is important to understand stringent DEA regulations required of a Research Lab. This training will give them a better insight on steps to take to maintain required record-keeping and effective security in order to prevent illicit use or diversion of any controlled substance. The presentation provides effective record-keeping for purchasing and dispensing of controlled substances for testing or research purposes. Inventory, dispensing, usage and disposal records are part of the accountability process in order to comply with stringent DEA regulations.

Live live online training only for one participant Price: $195.00

Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)

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Areas Covered in the Session: l ROLE OF DEA familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances.
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Marianne H. Harper Director, The Art of Practice Management Susan E. Mazer President & CEO, Healing HealthCare Systems, Inc. MoreSpeakers

CIVIL ACTIONS Briefly describes the civil actions and fines imposed by the U.S Attorneys Office on a DEA registered Research Lab for failures to comply with DEA record-keeping and security regulations. ADMINISTRATIVE ACTIONS - Provides an insight into the administrative actions that results from violations of stringent DEA regulations imposed on a Research Lab facility. DEA COMPUTATION CHART - Understanding how the audit process is performed by DEA 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: inventory, order forms, invoices, dispensing, usage and disposal in testing, thefts & losses, power of attorney, and drug destructions. SECURITY REQUIREMENTS - Covers stringent security requirements in order to prevent the diversion of any controlled substance. SENDING DOCUMENTS TO DEA - Learn the methodology and requirements for mailing documents to the local DEA office.

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Who will Benefit: Senior and mid-level Manager Scientists Chemists registered with DEA as a Research Facility in a facility doing research with controlled substances.

Carlos M. Aquino brings 36 years of experience of handling illicit and pharmaceutical controlled substances and regulated chemicals. His testimonial ability, both in federal and state courts, is proof of his investigative experience and skills. Carlos has 12 years of experience working for Philadelphia DEA Diversion Group, which is responsible for initiating prosecutions of those DEA registrants who violate the federal Controlled Substances Act or DEA regulations pertaining to handling these substances. This has included eight years as a Diversion Investigator and four years as a Group Supervisor. During his time at the DEA, he performed numerous regulatory inspections of manufacturers, distributors, importers/exporters, physicians, researchers, and pharmacies in order to determine their compliance with the federal laws and DEA regulations pertaining to controlled substances in Schedules II through V and regulated chemicals. In addition to the above, Carlos has over 20 years of experience working for various law enforcement agencies including the Philadelphia Police. Carlos has a BA in Criminal Justice and has taught numerous courses during his time at the DEA. He is skilled in interpreting the Controlled Substances Act (CSA) and the Code of Federal Regulations (CFR), assisting the pharmaceutical industry with compliance, and preparing and submitting Drug Enforcement Administration (DEA) Forms 41, 104, 106, 222, 236, 486.

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