Sweeping enforcement of DQSA has begun and will accelerate. How will it affect you? This webinar will address the following:
- How has FDA’s enforcement against compounding pharmacies changed since passage of the DQSA?
- What types of issues is FDA finding when it inspects compounding pharmacies?
- What limits does the FDA’s new draft guidance on essential copies place on compounders?
- What should you be aware of concerning compounded drugs when providing care to patients?
DQSA Compliance Presenters
Cynthia Schnedar, Greenleaf Health
Cynthia Schnedar, Executive Vice President of Regulatory Compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research, where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Before joining FDA, Cynthia served in leadership positions at the Department of Justice, where she specialized in compliance and enforcement issues.
Steve Lokensgard, Faegre Baker Daniels
Mr. Lokensgard, a partner at Faegre Baker Daniels, focuses on health law compliance, litigation, and digital health. He counsels pharmacies and health systems on compounding, drug diversion, telepharmacy, and 340B implementation. Prior to joining Faegre, Steve was the Chief Compliance Officer for a large regional health system.
WMT-006 Rev 01/2018