Short Course:

Sample Compliance & the PDMA

 

New for 2018, The Sharing Alliance will be bringing you one-day, learning-intensive Short Course programs focused on a single topic.

 

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 and old to this area of compliance; 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 mail@sharingalliance.org or call 914-747-1400.

Short Course:

Sample Compliance & the PDMA

 

 

Friday, April 20, 2018

8:30am - 3:00pm

Novartis 438 Auditorium, East Hanover, NJ

$399.00 per person

REGISTER NOW!

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