Webinar Recording – Drug Enforcement Administration (DEA) Regulations: Basic Principles of Controlled Substances Compliance

Tuesday, October 13, 2009

10:00 a.m.-11:00 a.m., Eastern Standard Time (United States)

Instructor: John Stromp,former Manager Documentation, Regulatory and Compliance, GlaxoSmithKline

➢This Recording is now part of a CONTENT package - Click Here for more details

➢Invite as many co-workers as possible for this training. Quality content training for one low price (only ONE login allowed - must be in one location). In addition you also receive:

➢PowerPoint Presentation (PDF)

➢Webinar recording

➢Frequently Asked Questions and Answers Document on subject matter content

➢Free Membership in enKap's FDA Compliance learning community - simply fill out a profile

Webinar Content

The Drug Enforcement Administration (DEA) is located within the United States Department of Justice and sets requirements to monitor pharmaceuticals containing controlled substances. This webinar provides a basic understanding of DEA regulations that govern the manufacture and distribution of controlled substances. You will learn how the DEA enforces the laws under the Controlled Substance Act, and how these regulations complement the laws under the Food Drug & Cosmetic (FD&C) Act that are enforced by the Food and Drug Administration (FDA).

Role of DEA

➢Role of the DEA

➢DEA versus FDA: Regulations and Enforcement Authority

DEA Classification of Controlled Substances

➢Schedules

➢Derivatives

➢Opiates

➢Hallucinogens

➢Stimulants

➢Depressants

➢Diversion

Registration for the Manufacture and Distribution of a Controlled Substance

➢Certificate of registration - Who? What? When? Where?

➢Renewal and Revocation

Controls to Ensure the Security of Controlled Substances During Manufacture, Testing, Sale and Distribution

➢Material and Product Controls - Limited Access Areas, In-process Handling

➢Facilities - Locked Storage Areas, Secured Perimeter, Secure Construction, Authorized Accessibility

➢Employees - Pre-employment screening, Employee Diversion Policies

➢Sales and Distribution - Security Measures, Suspicious orders

Documentation Requirements for Controlled Substances Manufacturers

➢Recordkeeping Practices

➢Types of Records - Inventory, Manufacturing Process, Sales and Distribution, Product Returns and Disposal

QUESTIONS AND ANSWERS

There will be a 15-minute question and answer period for attendees to submit questions. If we are unable to answer your question due to time constraints, our instructor John Stromp will provide an email response after the webinar concludes.

WHAT YOU WILL LEARN ATTENDING THIS WEBINAR

➢The role of the DEA and how this federal agency enforces the regulations applicable to controlled substances

➢DEA vs. FDA: regulations, enforcement authority, etc.

➢How controlled substances are classified by the DEA

➢The registration process for the manufacture, distribution and sale of controlled substances,/p>

➢Requirements for controlled substances

➢Documentation and recordkeeping requirements for manufacture, sale and distribution of controlled substances.

WHO SHOULD ATTEND THIS WEBINAR

Individuals with experience in GMP regulations, drug manufacturing processes and those involved in the manufacture, sale and distribution of controlled substances, including drugs which contain a controlled substance. Individuals who work in Regulatory Affairs, Quality Assurance, Validation, Quality, Operations, and Manufacturing should attend this webinar.

ABOUT YOUR INSTRUCTOR

John Stromp currently serves as a Subject Matter Expert and Instructional Designer for enKap. In his career, he has worked at Bausch & Lomb, Duramed Pharmaceuticals, Glaxo SmithKline and American Red Cross in packaging development, quality assurance and regulatory affairs.

As former Manager, Documentation, Regulatory and Compliance at GlaxoSmithKline, his DEA compliance responsibilities included serving as the lead individual for DEA inspections, monitoring security systems for the holding of controlled substances, filing required DEA reports, maintaining DEA registration certificates for facilities, reviewing distribution records for controlled substances, reviewing receipt, inventory and product return records for controlled substances, reviewing reconciliation records for controlled substances, witnessing and verifying destruction of controlled substances, serving as the point of contact for the DEA to answer their inquiries, and reviewing and approving labeling for controlled drug products.

➢This Recording is now part of a CONTENT package - Click Here for more details