AMWAJournal.org 27Session Reports • Second (or even third) computer monitor • Printouts of grant request for proposals and request for applications • Templates for writers • Glossaries from cancer centers or other stakeholders • Digitally curating information • Time tracking/management tools • Optimizing software already in use • Checklists and detailed project notetaking A medical writer’s ability to take on new projects depends on the scope and timeline for a given document. Clear communication, educating the client, and setting expectations and boundaries upfront are needed to ensure the project is completed according to the timeline, without compromising quality. In their presentation, Ms Byram, Dr Singleton, and Dr Chiavolini provided several strategies for assessing the ability to take on a project with a tight time- line, as well as several tools for creating high-quality docu- ments within that timeline. Stephany Panlilio is a Senior Associate in Medical Writing at Gilead Sciences, Inc. (Foster City, CA) Author declaration and disclosures: The authors note no com- mercial associations that may pose a conflict of interest in rela- tion to this article. Author contact: stephany.panlilio@gilead.com * * * TIME TO CLOCK IN: APPLYING MANUFACTURING BEST PRACTICES TO CONSISTENTLY AND EFFICIENTLY PRODUCE HIGH-QUALITY DOCUMENTS Speaker Jenni Pickett, PhD, Whitsell Innovations, Inc., Chapel Hill, NC Mary Ellis Bogden, BA, Whitsell Innovations, Inc., Chapel Hill, NC By Stephany Panlilio, MS Regulatory writing and manufacturing have many com- monalities. As with manufactured products, regulatory doc- uments should be produced at a reasonable cost, completed per an agreed upon timeline, be fit for intended purpose, and should meet a set of corporate, legal, and customer standards. What can regulatory writers learn from advances in manufacturing processes? Manufacturing Best Practice Philosophies Many modern manufacturing processes and principles came from the car manufacturer, Toyota. The Toyota Way operates under 4 driving principles.1 These principles can also be applied to medical writing, as described below. • Long-term Philosophy – Forward Thinking. Focusing on the processes used to create products or documents can help improve efficiency over time. • Add Value to the Organization by Developing Your People and Partners. In manufacturing and regulatory writing, ensuring that team members have the right skills is essential. • The Right Process Will Produce the Right Results. A robust process will ensure a high-quality product. • Continuously Solving Root Problems Drives Organizational Learning. Manufacturers and regulatory writers should develop and maintain a system to identify root causes and quickly address issues. Good Regulatory Writing Practice Manufacturers of pharmaceutical products must adhere to Good Manufacturing Practice (GMP) to mitigate risk. A robust GMP quality system includes training people; con- trolling starting materials and equipment; clearly defining manufacturing, packaging, and storage processes; testing for quality; and documenting each step. To produce high-quality documents, the following are necessary: trained people, correct source materials that are up-to-date and easy to use, defined processes for the writing and review cycles, a quality control review process, and doc- umenting each step (Figure). So, what would a theoretical good regulatory writing practice include? • Developing the team by ensuring team members have the proper education, relevant experience, and knowl- edge of regulations and company policies can help to reduce the risk of human error. Specific risks to your team can be evaluated by a gap analysis of critical skills. Cultivating a growth mindset culture in which employees feel comfortable being noisy in their igno- rance helps identify critical training needs. • Creating a Quality Document Profile, similar to the Quality Target Product Profile used in GMP, verifies the correct template, sources, interpretation, and team expectations are used for the document. Using a storage management system prevents errors due to use of incorrect templates, outdated data, or irrelevant sources. http://www.amwajournal.org AMWAJournal.org 28Session Reports • Protecting the data and text by using good data hygiene and limiting review cycles prevents transcrip- tion errors, incorrect data interpretation, and inconsis- tent text or messages within the document. Reviewer fatigue and consistency errors can be reduced by wait- ing until the last review to write certain sections, such as the executive summary, synopsis, list of abbrevia- tions, and summary of changes. • Using risk-based quality control techniques can improve efficiency and ensure the most important areas in the document are correct. In GMP, Critical Quality Attributes (CQAs) are factors which would impact the overall quality of the product. Identifying CQAs in your document (ie, new data in an investiga- tor brochure) can help your reviewer prioritize where to start. • Recording the document development process in a tracker allows you to confirm you have followed all the key steps above and also see where improvements can be made. • Reviewing your document development process peri- odically will allow you to address new risks as you dis- cover them and improve efficiency and quality over time. GMP uses Corrective Action Preventative Action, a system in which root causes are identified, and solu- tions are proposed, verified, and implemented. Identifying risks throughout regulatory document pro- cesses and finding ways to proactively mitigate them are imperative steps to creating high-quality documents. As regulations evolve and processes increase in complexity, implementing elements of a good regulatory writing prac- tice provides a framework to focus on long-term invest- ments in efficiency and quality of your documents by continually improving your people and processes. Stephany Panlilio is a Senior Associate in Medical Writing at Gilead Sciences, Inc. (Foster City, CA) Author declaration and disclosures: The authors note no com- mercial associations that may pose a conflict of interest in rela- tion to this article. Author contact: stephany.panlilio@gilead.com Reference 1. Liker, JK. The Toyota Way: 14 Management Principles from the World’s Greatest Manufacturer. McGraw-Hill; 2004. Figure. Elements of a theoretical good regulatory writing practice. http://www.amwajournal.org