Why Less is More, Dec. 7-8, 2017, Arlington, VA

SOPs Dec 2017

SOPs for the 21st Century:

Why Less is More

**Presented by FDAnews and Cerulean Associates LLC **

Dec. 7-8, 2017 – Arlington, VA


A well-written SOP is not a static, one-time effort.

It has life. It acts as a foundation, but one that’s flexible like a car’s frame and suspension, on which compliance can be achieved confidently.

It helps drug and devicemakers demonstrate compliance and say to inspectors: “We know what we are doing — and why.”

This workshop provides attendees an opportunity to hear from John Avellanet, an acknowledged SOPs expert and share experiences and learn from fellow attendees who are confronting the same issues.

By attending this critical workshop and attendees will find out:

  •     How to quickly parse warning letters and Form 483s for SOP expectations
  •     What FDA investigator questions to expect about SOPs and policies
  •     How to take advantage of the Policy-SOP-Task Outline hierarchy
  •     How to use forms, checklists, and templates to reinforce compliance
  •     And much more…

Attend this highly-interactive, two-day workshop that will teach attendees the practical techniques needed for writing fast-read, flexible and compliant SOPs. SOPs that will meet FDA requirements as well as today’s globalized expectations.

Meet the Presenter:

John Avellanet, Founder Cerulean Associates LLC

John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs…

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