Brought to you
by the not-for-profit
PDMA Alliance Inc. dba:
Friday, April 20, 2018
8:30am - 3:00pm
$399.00 per person
Novartis Pharmaceuticals Corporation
One Health Plaza
Building 438 Auditorium
East Hanover, NJ 07936-1080
Thanks to our Short Course sponsors!
& the PDMA
This six-hour, learning-intensive Short Course will focus on how your company can remain compliant around its sample distribution policies and practices. The material to be presented on the PDMA, and more, will be of value to those new &/or familiar with this area of compliance. It will benefit individuals in Compliance, HR, Legal, Sales Operations, Regulatory Affairs, Training and IT, and will serve as a road map on how to assess and enhance your current practices.
Areas to be covered include:
The Why - A walk through the history of laws and regulations around sample compliance will help you understand the “why” of government sample compliance mandates, and their critical importance in ensuring a safe and secure drug supply chain.
The PDMA, Rules & Guidance - A detailed discussion of the federal laws, regulations, and FDA/OIG guidance specific to sample accountability and compliance will provide a complete “library” of reference material to support your understanding of federal requirements.
The Key Elements of a Strong Sample Compliance Program - Drawing from laws and guidance, as well as the 28 years of Sharing Alliance™ experience, we will cover specific sample compliance elements and how they should translate into documented SOPs.
State & Local Laws/Regulations - The challenges of the ever-changing landscape of other jurisdictional sample compliance mandates will be covered, with suggestions on how to remain current on compliance responsibilities beyond those mandated by FDA law.
Open Forum - In group discussion, we will open the floor to your questions and concerns, providing you with the added opportunity to learn from the experiences of your peers.
Questions? You can reach us at email@example.com or call 914-747-1400.
This event has been approved for CCB CEUs!*
Sample Allocations • Practitioner Validation • Reconciliations • Reporting • Storage • Significant Loss
Third Parties • Inventory • Donations • Audits • Record Keeping • Sales Rep Records • Training
Packaging & Distribution • Sample Trending • Vouchers/Coupons • Direct to Practitioner
* The Compliance Certification Board (CCB)® has approved this event for up to 5.4 CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.