Contact: Michelle Butler
Marketing Manager
703-538-7665 phone

Come to Washington March 20-21 for a one-of-a-kind learning experience — the industry’s first business-writing workshop focused exclusively on improving writing performance within FDA-regulated companies for better FDA inspection outcomes. Working collaboratively on real-world example documents, attendees will follow the proprietary Writing for Compliance® Structured Document Process, which will help develop a variety of compliance-implicated documentation.

FALLS CHURCH VA USA – Jan. 13, 2017

Writing for Compliance®

Improving FDA Inspection Outcomes Through Better Documents

**Presented by FDAnews**

March 20-21, 2017, Arlington, VA

The FDA inspection was set for Monday morning and boy, and the manufacturer was ready. They’d collected all necessary documentation, spent time and money prepping SMEs, then war-roomed with the team into the wee hours. Yet here they are, looking at a decidedly lukewarm inspection report or even a Form 483.

What went wrong?

Communications, possibly. It’s the missing element to a great FDA inspection outcome. Yet surveys show more than half of people tasked with writing documents for FDA submission have never even taken a business writing course.

But clear, effective writing is crucial. If the investigator can’t understand what was done, why it was done or why it doesn’t jibe with expectations then the manufacturer might as well not have prepped at all.

Introducing an all-new industry-leading workshop that will help improve the outcome

This is not just any business writing course. It is the one and only targeted exclusively at the FDA. Attendees will learn a novel technique called the Writing for Compliance® Structured Document Process, a systematic approach to clear and effective communication. Discover:

  • How clumsy writing turns off FDA investigators
  • The difference between clumsy and artful
  • The Structured Document Process path to clear, concise communications
  • And much more!

Be ready for hard work. Over two more-than-full days, attendees will be reviewing real-world quality records, some terrific and some terrible. They will be writing plenty too, then facing tough but constructive critique. At the end, they will be able to rest easy on the eve of Inspection Day because they’ve answered all the right questions:

  • What is the purpose of the document?
  • Who is the audience, and does it stand on its own?
  • Is the structure logical and organized?
  • Is there both situational and technical context?
  • Is the analysis correct?
  • Are conclusions presented clearly?
  • Will it stand up to independent review?

All attendees will receive a complete manual of all materials, along with the Writing for Compliance® Structured Document Rubric.

Co-instructor Jack Garvey is the founder and chief executive officer of Compliance Architects LLC®, a leading consulting and advisory firm specializing in innovative quality and compliance solutions for FDA-regulated manufacturers. As both a chemical engineer and practicing attorney, Jack possesses the legal, regulatory, quality and compliance expertise that allows him to excel at the complex interplay of science, law and business. Jack possesses over 30 years of hands-on technical, operational, quality, regulatory and legal experience at top-performing life science companies including Johnson & Johnson, C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst Laboratories.

Co-instructor Deborah Lydick is president of Catalyst Advantage Group LLC, consults with and assists medical device and pharmaceutical clients to achieve compliant quality systems.  Deb has over 35 years of industry experience managing quality assurance, regulatory compliance, operations, QC laboratories and quality management consulting. She was an adjunct professor and holds certificates in training design and delivery, quality system auditing and six-sigma black belt.

Conference Details:

Writing for Compliance®

Improving FDA Inspection Outcomes Through Better Documents

**Presented by FDAnews**

March 20-21, 2017, Arlington, VA


Early Bird Registration: $1,297 (until Feb. 20, 2017)

Regular Registration: $1,497

Easy Ways to Register:

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.