Embracing Change While Maintaining Compliance

1. ”Embracing Change While Maintaining Compliance”
Parenteral Drug Association Southeast Chapter Spring Conference Tuesday, May 8, 2018
08:00 – 08:30 Registration/Breakfast
08:30 – 09:00 Opening Remarks
 Renee Morley, President SE Chapter
2018 Elections, Volunteer Opportunities, Housekeeping
 David Yaffe, Program Committee Chair
Welcome Message and Discussion of Day Ahead
09:00 – 09:45 Opioid Epidemic Update
 DEA Diversion Control Division
09:45 – 10:30 Eudralux Volume 4 Annex 1 Implementation of Changes
 Kelly Waldron
Valsource
 Amanda McFarland
Valsource
10:30 – 11:00 Vendor Show/Networking/Break
11:00 – 12:00 Blockchain Technology
 Speaker invited
12:00 – 01:00 Lunch
01:00 – 01:45 The SME’s Role in Maintaining Compliance
 Charles Lankford
CEO, Pharmasys
01:45 – 02:30 Existing Facility Expansion, Case Study
 Speaker Invited
02:30 – 03:00 Vendor Show/Networking/Break
03:00 – 03:45 Electronic Validation Lifecycle Management – A Case Study
 David Yaffe
Commissioning Agents
 Charlie Maher
Commissioning Agents
03:45 – 04:30 Genomic Profiling
 Austin Caudle
IQIVIA
04:30 – 05:00 Panel Discussion – Compliance Changes in Pharma