DEA: Controlled Drug Substances

Join us for an informative and interactive day of DEA training. 

Our experts will guide you through DEA regulations and answer all of your DEA-related questions. 

Our instructors are John Robertson – former DEA Diversion Investigator for the Philadelphia Field Division and Michael Gankiewicz – Associate Director of DEA and Security for Lannett Company.

This one-day program focuses on the rules and regulations governing the manufacture, warehousing, processing, packaging, labeling, distribution, and reconciliation of all classes of Controlled substances.

The course is designed to help participants  become and/or remain compliant with DEA rules and regulations on Controlled Drug Substances, as governed by the Drug Enforcement Administration (DEA) and related state agencies.

INSTRUCTORS

John Robertson 

John is a Senior Consultant for Jeiven Pharmaceutical Consulting, Inc. (JPC), specializing in DEA compliance, is an expert on new registration and import requirements for Controlled Drug Substances and List I chemicals, physical security of sites, and DEA regulations. He audits companies to assess DEA compliance and consults for companies regarding the proper handling and disposal of controlled and List I substances, and on documentation compliance. John provides DEA training to JPC clients throughout the US, and is a subject matter expert for Regulatory DEA compliance.

Prior to consulting, John was a Senior Supervising Diversion Investigator for the DEA and has extensive DEA experience in both criminal and civil investigations. He held top level security clearance and was instrumental in counter-intelligence drug operations in Mexico and Panama. He also served as the National Security Agency’s European Liaison Officer. 

Michael Gankiewicz

Mike is the Associate Director of DEA and Security for Lannett Company where he is responsible for all DEA compliance and reporting. He is the Lannett Company representative for DEA inspections and DEA correspondence.  He is responsible for generating, implementing and filing of all DEA forms including the Acquisition of Controlled Substances, Quota, Import/Export, Theft/Loss, Destruction, etc.

Mike conducts periodic audits of Manufacturing and respective departments to ensure compliance with DEA regulations. He reports non-compliance and takes appropriate corrective action. He performs annual inventory of CII, CIII and CIV substances (i.e. Oxycodone, Hydrocodone, Amphetamine, etc.) and compiles data for Year End Report submission. He coordinates and implements the destruction of controlled substances.

Mike developed and implemented the overall security program for all company facilities.  He maintains State and Federal Registrations, pertaining to the inclusion of any new policies and/or procedures. He monitors controlled material movements as related to receipts, production, shipments and destruction,  acquires all necessary data and submits for the DEA procurement quota (encompasses all controlled substance usage). In addition to co-teaching our course Mike also trains personnel within Lannett regarding DEA regulations.

Refund/Cancellation Policy

We understand that sometimes due to unforeseen circumstances people are unable to attend a course they have registered for. Please click here to see our course refund page and to see our policies regarding course cancellation.

Register Today

For registration or any questions please contact us at (908) 233-4508

Course Topics

  • Overview of DEA
  • DEA Registration – State and Federal
  • DEA Orientation for New Employees 
  • Employee Screening (background checks) 
  • Personnel – including employee responsibility to report diversion
  • Facility Design
  • DEA Security Requirements 
  • Controlled Substances Receipt, Storage, Handling and Shipping 
  • Recommended SOPs  
  • Labeling Requirements
  • Listed Chemical and Certain Machines
  • Quota - Manufacturing and Procurement 
  • Electronic Submissions
  • Inventory Requirements 
  • Returns, Disposal, Destruction
  • Record Keeping
  • YERS: Year End Reporting 
  • ARCOS
  • 222 Order Forms
  • DEA Accountability Procedures
  • CSOS: Controlled Substance Ordering System
  • SOM: Suspicious Order Monitoring
  • KYC: Know Your Customer
  • Power-of-Attorney
  • Import/Export  
  • WHAT TO EXPECT WHEN THE DEA SHOWS UP

John will teach you everything you need know including what to do (and NOT do) when the DEA shows up to your site. He will walk you through the questions you can expect, documents you will be asked to produce, and will give you tips on how to prepare your employees for an unexpected DEA inspection.

THIS COURSE CAN BE OFFERED ON-SITE AT YOUR COMPANY. 

PLEASE CONTACT US IF YOU WOULD LIKE MORE INFORMATION ABOUT ON-SITE DEA TRAINING

Register Today

For registration or any questions please contact us at (908) 233-4508