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November 16 - 17, 2020
The Westin Arlington Gateway,
Arlington, VA

Solutions to Unravel Regulatory Complexities, Strengthen Quality Programs and Ensure Inspection Readiness

The only event of its kind for compounding professionals, providing the necessary information to comply with changing quality standards.

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What to Expect

 

Discuss Critical Topics Transforming the Compounding Landscape
  • FDA’s Evolving Policies and Priorities for Drug Compounding 
  • Regulatory Inspections and Responding to 483s
  • Compliance with USP <800>, <795> and <797> Standards
  • Training Programs  for GMP Compliance
  • Effective Vendor Qualification and Auditing Procedures
Multi-Stakeholder Perspectives on Identifying and Interpreting Necessary Standards

Expert Thought-Leaders Sharing Insights From:

  • FDA
  • State Boards of Pharmacy
  • United States Department of Justice
  • 503A Pharmacies
  • 503B Outsourcing Facilities
  • Hospital/Health System Pharmacies
  • Veterinary Pharmacies
  • Analytical Labs
Overcome Specific Challenges to Developing Compliant Policies and Procedures

Tailored Experience Through 3 Comprehensive Tracks:

  • 503A ● Track Chair: Doug Yoch, PharmD, Owner, Stanley Specialty Pharmacy
  • 503B ● Track Chair: Melissa Stefko, Vice President of Quality, Wells Pharmacy Network
  • Hospital/Health-System ● Track Chair: Kevin Hansen, PharmD, MS, BCPS, BCSCP, Assistant Director of Pharmacy, Moses H. Cone Memorial Hospital
Continuing Education and Professional Development
  • 10+ Hours of ACPE Credits for Pharmacists
  • 7+ Hours of Networking with a Diverse Group of Industry Leaders
  • Peer-to-Peer Opportunities — Engaging Roundtables and Discussion-Based Sessions

Exclusive FDA Insights from

  • Ian Deveau, Ph.D., Division Director (Acting), FDA/CDER/OC/OMQ/Division of Drug Quality 3
  • Steven Solomon, DVM, MPH, Director, Center for Veterinary Medicine, FDA
  • Gabrielle Cosel, Policy Analyst, FDA/CDER/OC
  • Lori G. Cantin, RPh, PharmD, Acting Branch Chief, Compounding Operations Branch, FDA/CDER/OC/OUDLC
  • Marci Kiester, PharmD, MSHS, RAC, Senior Policy Analyst, FDA