FDA’s New Concept of Operations for Drug Inspections and Evaluations - Webinar Recording/Transcript

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FDA’s New Concept of Operations for Drug Inspections and Evaluations: What You Need to Do Today

ConOps is the acronym for a soon-to-take-place FDA restructuring that’s certain to affect drug inspections going forward.

How will the agency’s new vertically integrated, programmatically aligned environment affect the new roles and responsibilities of CDER and ORA? Which new offices and individuals will you be talking to, and how should you be talking to them? What timeframes should you expect? What will the best ways be to encourage the agency to meet its commitments when the restructuring is complete?

You’re going to need a new roadmap. And FDAnews is ready with it.

Former CDER compliance directors Cynthia Schnedar Esq. (2014-16) and Howard Sklamberg Esq. (2012-14) reveal agency plans and how they’ll affect … you. Get ready to discover:

  • Inspectional issues: Which agency officials will hold the high cards after the new ConOps process is in place
  • What will change: The new tone of interactions when approaching the agency on specific inspection and evaluation topics
  • Timeframes and deadlines: What to expect from the FDA in conducting inspections and communicating results you need ASAP
  • What you can do now: New ways in which you’ll be able to encourage the FDA to meet commitments
  • Difficulties facing the agency in implementing its new concept of operations
  • And much more!

ConOps will be a reality before you know it. If you count on a clean bill of health from FDA drug inspectors, it behooves you to find out agency plans before they take effect.

  • Regulatory executives
  • Compliance executives
  • Quality control
  • Manufacturing/GMP
  • Legal counsel
  • Consultants

Meet Your Presenters

Cynthia Schnedar Esq., Executive VP-Regulatory Compliance at Greenleaf Health LLC, was director of the FDA Office of Compliance, CDER 2014-16, where she spearheaded FDA efforts to protect the public health by ensuring companies comply with federal standards for quality and safety. Previously she served at the Department of Justice as Acting Inspector General and in other leadership positions focusing on compliance and enforcement issues. In her present role with Greenleaf Health, a leading regulatory consultancy, she provides strategic advice to clients in the life sciences industry. 

Howard Sklamberg Esq., a partner in Akin Gump Strauss Hauer & Feld LLP’s health care and life sciences practice, focuses on regulatory compliance and strategy involving food and drug law. Mr. Sklamberg served as Director of the FDA’s Office of Compliance, CDER (2012-14). More recently he was Deputy Commissioner for Global Regulatory Operations and Policy and oversaw the Office of Regulatory Affairs and Office of International Programs. At the FDA he led product quality and safety efforts including global data-sharing, development and harmonization of standards, field operations, compliance and enforcement activities.