As a packaging engineer working in an FDA-regulated industry, there may be an opportunity to generate a filing to meet a regulatory requirement. This may be a filing focused solely on packaging, or it may be simply the packaging-related sections of a much larger product or process submission. Either way, the packaging engineer is often asked to author a submission.
The goal of any filing is to gain approval/clearance in the shortest amount of time without triggering any doubt in reviewers’ minds that might lead them to ask questions. When writing the filing, leave nothing to chance. As the packaging subject matter expert (SME), generate an accurate document with thorough and compelling facts. With that goal in mind, here are some tips that may be helpful to packaging engineering authors.