Presents
Clinical Supplies: The Basics
September 23-25, 2008
Woodbridge Hotel & Conference Center - Iselin, NJ
Clinical Supplies: The Basics is a three-day intensive and
practical program focusing on the fundamentals and selected advanced topics of
the Clinical Supplies process according to current Good Manufacturing Practices
(cGMPs), and FDA and ICH guidelines.
COURSE DESCRIPTION AND
OBJECTIVES
Our goal is to provide an intensive, practical program stressing the BASICS
of the Clinical Supplies process. Application of the fundamental concepts will
be achieved through presentations, workshops, case studies, life experiences,
and lively interaction between instructors and participants. Each participant
will study the Clinical Supplies Life Cycle and leave the program with a better
understanding of their role, and where they fit into the Clinical Supplies
process and the Clinical Team. Additionally, at the conclusion of the course,
they will be able to:
- Describe the clinical phases of drug development and the types of clinical
studies conducted in each phase
- Use and apply basic cGMPs to everyday work situations
- Distinguish WHY and HOW to control drug product, labeling, and packaging
components
- Summarize the importance of good documentation, and explain how to achieve
it
- Define the role of other groups or departments in the Clinical Supplies
process
- Evaluate their role, regardless of their position, as QUALITY CONTROL
Finally, our goal is to have each person return to his or her organization
with the skills and enthusiasm to be a more productive team member.
Introduction to Clinical Supplies and the CGMPs
|
Patient and Site Compliant Labeling and Packaging |
Phases of New Drug Development & Approval |
Global Blinding and Randomization Concepts |
Documentation Requirements for Clinical Supplies |
Stability According to the CGMPs, and FDA and ICH Guidelines |
Clinical Supplies Life Cycle |
Shipping and Distribution |
Clinical Supply SOPs |
Returned Drug Accountability |
Material Control |
Impact of Proposed Changes to CGMPS |
FDA's Focus on Employee Training |
Outsourcing Best Practices |
Clinical Protocol Interpretation |
QA/QC Basics for Clinical Supplies |
WHO SHOULD ATTEND
Our BASICS training program is designed to build a
solid understanding of Clinical Supplies for:
CLINICAL
SUPPLIES TECHNICIANS |
CLINICAL
SUPPLIES SUPERVISORS AND MANAGERS |
QA/QC
ASSOCIATES |
CLINICAL
RESEARCH ASSOCIATES |
REGULATORY
AFFAIRS PROFESSIONALS |
ADMINISTRATIVE
SUPPORT STAFF |
OTHERS
involved with the CLINICAL SUPPLIES PROCESS |
Co-Director: Steve Jacobs
Steve Jacobs, MBA, RPh, is the President of Global BioPharm Solutions, LLC. Prior to this, he was President of Bilcare Pharma Packaging Research in Phoenixville, PA. He has also held key positions at J&J Pharmaceutical research and Development, McNeil Consumer Healthcare, and Otsuka America in the area of Clinical Supplies
Guest Speaker: Marty Jeiven
Marty Jeiven, MS, RPh, is the President of Jeiven Pharmaceutical Consulting,
Inc., Pharmaceutical Training Seminars, Inc., and Pharmaceutical Staffing
Solutions, LLC, and the founder of the Clinical Supplies Support Group.
FEE: ........$1695 (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 $1645 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, money order or Credit Card.
Please make payable to Pharmaceutical
Training Seminars, Inc.
Registration for the seminar will begin at 7:30 a.m. The program commences at 8:00 a.m. each day, and concludes at 4:30 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.
“Very dynamic, engaging and motivating.”
Jessica Sonevystky, Merck & Co., Inc.
“Thoroughly enjoyed the seminar and will definitely be able to use the
learned material in my current job.”
Wendy Friis, Aventis Pharmaceutical
“Highly interactive and motivating.”
Lisa Falzone, Berlex Laboratories
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.
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
To pay by credit card please use the below link which can be e-mailed to
tbodziony@jeiven.com or faxed to Tracy
Bodziony (908) 654-4829
Credit Card Payment
Form.doc
PHARMACEUTICAL TRAINING SEMINARS, INC
E-Mail
| 
