Presents

DEA: Controlled Drug Substances

October 7 - 8, 2008
Woodbridge Hotel & Conference Center - Iselin, NJ

Controlled Drug Substances is a two-day program focusing on the rules and regulations governing the manufacture, warehousing, processing, packaging, labeling, distribution, and reconciliation of all classes of Controlled Substances for both clinical and commercial products.

COURSE DESCRIPTION AND OBJECTIVES

This seminar will provide a basic understanding of the rules and regulations on controlled drug substances, as governed by FDA, Drug Enforcement Administration (DEA), and related state agencies.

At the conclusion of the course, each participant will be able to:

1. Apply their knowledge and understanding of the obligations imposed upon all DEA registrants to compliment the basic requirements of FDA Current Good Manufacturing Practices (CMGPs);
2. Acquire the knowledge necessary to complete required periodic reports and inventories;
3. Plan and implement security procedures required for operational control at all stages of manufacturing, packaging, labeling, processing, warehousing, and distribution of controlled substances;
4. Recognize the importance of documentation as it relates to control of operations;
5. Anticipate the expectations during a DEA inspection of their facility; and
6. Prepare written Standard Operating Procedures (SOPs) which will provide for 100% control of the controlled substances operation.

COURSE CONTENTS

     ANALYTICAL, RESEARCHER AND MANUFACTURER

• Registration
• Record Keeping
• Procurement Quotas
• Security
• Destruction Processes
• ARCOS Reporting

    DEA INSPECTIONS

• Internal Auditing
• Training
• Designing & Planning Security
• Reports
• Accountability
• Personnel Issues

    CLINICAL TRIALS

• Labeling
• Controls
• Returns
• Accountability
• Packaging
• Security
• Destruction
• Overseas Sites

    IMPORT/EXPORT

• APIs
• Finished Dosage Forms

WHO SHOULD ATTEND

    Our Controlled Drug Substances training program is designed for:

• Clinical  Supplies Personnel
• QA/QC Associates
• Production Personnel
• Formulation Scientists
• DEA Compliance Officers
• Regulatory Affairs Professional
• Procurement Professionals
• Warehousing/Distribution Personnel
• Administrative Support Staff

INSTRUCTORS

Co-Director: Joseph Saccomanno

Joseph Saccomanno is a graduate of St. John’s University, Queens, NY USA with a Bachelor of Science degree in Pharmacy. He received his Masters of Science degree in Clinical Pharmacy, also from St. John’s. Joe’s professional career began as a community pharmacist followed by three years in hospital pharmacy. Joe then spent 12 years working in the Clinical Trial Supplies Department for American Cyanamid’s Medical Research Division, Pearl River, NY. After leaving American Cyanamid, Joe accepted a director position at BlisTech Corporation, Fairfield, NJ. He is currently working at Schering-Plough as Manager, Worldwide Clinical Supplies Planning and has held various director positions, including Operations, Project Management and most recently Study Planning & Design. In this capacity, Joe’s department was responsible for production planning, project timeline creation and maintenance, component and tooling design and qualification, controlled drug substance storage, dispensing, US DEA correspondence, and facility maintenance.

Co-Director: Annie Zanolli

Annie Zanolli holds a Masters of Science degree in Pharmaceutical Quality Assurance and Regulatory Affairs from Temple University.  Annie is currently the Manager of Quality Assurance and Compliance at Bilcare Global Clinical Supplies Americas, where she is responsible for DEA Compliance and other Quality Assurance functions.   She has also worked as a GMP Compliance Auditor supporting the Global Clinical Supplies Operations at Merck & Co., Inc. 

FEE

FEE: ........$1300 (U.S.)
Fee includes tuition, course notes, continental breakfasts, lunches, and morning and afternoon breaks. Please note this fee does not include hotel accommodations, travel costs, and evening meals.

Discounted fee of $1050 each for three or more enrollments from the same company

Payment is required no later than 10 business days prior to the training course.
You may pay by check or money order or Credit Card.

Please make payable to Pharmaceutical Training Seminars

Registration will begin at 8:00 a.m. The program commences at 8:30 a.m. each day, and concludes at 5:00 p.m.

Dress is business casual.

Applicants may cancel up to fifteen business days prior to the start of the course to receive a full refund. Substitutions may be made at any time prior to the start of the course.

COURSES AT YOUR LOCATION

Our program can be customized and conducted at your company location. In-house programs provide the added benefit of educating many employees simultaneously and customizing the program to your company-specific needs. Please contact Tracy Bodziony at (908) 233-4508 for more information.

REGISTRATION FORM

PHARMACEUTICAL TRAINING SEMINARS, INC.
(A Division of Jeiven Pharmaceutical Consulting, Inc.)

Register Via Fax // Register Via Online Form

If faxing, fax the registration form to Tracy Bodziony at (908) 654-4829
Send check (payable to PTS) to:

Tracy Bodziony, Manager of Training Programs
Pharmaceutical Training Seminars, Inc.
6 Jacobs Lane
Scotch Plains, NJ 07076

or Complete the following credit card form and fax or e-mail back to tbodziony@jeiven.com:

Credit Card Payment Form

PHARMACEUTICAL TRAINING SEMINARS, INC
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