The full-day course is divided into four main sections:
“The Problem” sets the stage for improvement and reviews a primary reason that many company’s don’t perform well during FDA inspections. To ensure linkage to inspection outcomes, time is spent on reviewing FDA Warning Letters that were likely caused by (or were contributed to by) poor writing practices. This section reviews how FDA inspections can go wrong and into undesirable areas of inquiry from poorly written documents. This section also outlines the core principle of why good writing and good documents are so important to achieve the best FDA inspection outcomes.
“Recognizing Deficient Documents” focuses on inspection-relevant critical thinking skills, and takes workshop participants through the process of looking at quality records and highly-inspected document types through the eyes of an FDA Investigator. This section examines what FDA Investigators expect and what they typically see from regulated documents during inspections. The workshop explores how and why writing documents for compliance purposes is unique, and is truly an aggregation of other writing styles. A review of different types of quality records and inspection-focus documents and different primary writing styles is also conducted.
“Developing Compliant Documents” is the core of the workshop and provides workshop attendees with a defined process and specific knowledge to draft, structure and finalize significantly-improved compliance-implicated documentation. Building off of the ability to recognize poor compliance-implicated documents, the Writing for Compliance® Structured Document Process is introduced. This structured process will create significantly improved consistency across quality and operations staff, leading to improvements in all quality records. The corresponding Rubric provides an essential tool to support the document review and approval process. Other key concepts in this section include comparing and contrasting investigation and analysis, and reviewing the challenge and opportunities presented by representation of “data” in writing for regulators. Attendees will learn to apply the process and learning during interactive exercises.
“Compliance Writing Exercise” is the final section and is comprised primarily of our “capstone” writing exercise. This section is where all the concepts come together, and challenges attendees to rewrite documents that they have learned are deficient. A role-playing, FDA inspection challenge exercise helps attendees learn how the result of their writing can be challenged by FDA Investigators in an inspection setting, further solidifying concepts and helping attendees understand the impact of poor writing.