Writing for Compliance®

Writing for Compliance®  is the breakthrough workshop training that is FDA-regulated industry’s first and only formal training program devoted to improving FDA and regulatory inspection outcomes through improving writing skills within regulated companies.

Writing for Compliance PresentationUpdated and improved for 2016, Writing for Compliance®  now provides even more examples, Warning Letter references, exercises and structure for achieving best-in-class compliance-implicated documents.   Incorporating extensive input from former FDA Investigators and feedback from prior participants, the program features more exercises, more assistance with “what does good look like” and a new, defined writing process to provide increased consistency and improved outcomes for compliance writing activities.

In over four years of delivering the program to FDA-regulated companies, and with over two hundred mid-to-senior level management personnel having attended, an astonishing 95% stated that the workshop was relevant to the work they currently do, and 94% said they would recommend the workshop to a colleague!

Really enjoyed the session—very much in line with the issues I fight daily. Director of Manufacturing

The new Writing for Compliance® program covers a wide range of topics that are fundamental to writing for regulated industry purposes, including but not limited to:

  • the one thing you must do to succeed in any FDA or other regulatory inspection;
  • key principles of writing for regulators as a primary audience;
  • representing data, statistics, and scientific information;
  • focus on quality records and inspection-focus documents;   and
  • the incorporation of legal advocacy principles to maximize documents effectiveness.

Material is presented in lecture and through interactive workshop exercises designed to encourage critical thinking, improve writing skills, and highlight the importance of well-crafted documents to FDA compliance outcomes.

Workshops are now being scheduled for third and fourth quarter 2016.   Call us at 888-734-9778 now for availability to schedule your onsite workshop, or email us at w4c@compliancearchitects.com.

Check out the outstanding attendee comments from our original workshop!