Pharmaceutical Technical Writing

An appropriate level of pharmaceutical and biopharmaceutical technical writing skills is essential across all areas of quality processes and systems. Individuals with strong expertise in technical writing have a significant competitive edge in the industry. This training program offers a structured, step-by-step approach to mastering technical writing for the pharmaceutical field, complete with real-world case studies. The program focuses on a wide range of topics including an overview of technical writing, creation and management of technical documents and records, development of technical procedures, and the use of CAPA and change control systems. It also covers gap analysis, process mapping, data handling, trending, and the preparation of protocols and reports. Throughout the modules, students will explore how to write technical procedures, who is responsible for creating them, and how they are used in CAPA and change control systems. Students will gain hands-on experience through case studies that guide them in creating change control documentation, process maps, and protocol templates. Learning Outcomes Upon completion, students will be able to develop procedures, policies, protocols, and reports. They will be trained to investigate deviations and out-of-specifications, analyze and manage CAPA and change control processes, review and approve technical documentation, prepare for inspections, respond effectively to inspector comments, conduct gap analyses, and train other employees in technical writing best practices. Job Opportunities Graduates of this program will be well-equipped for roles such as Change Control Coordinators, Managers, Technical Writers, Auditors, Regulatory Affairs Associates, and Validation Specialists. Who Should Attend This program is ideal for beginners who aspire to become technical writers, as well as for current technical team members, management personnel, auditors, and consultants seeking to enhance their pharmaceutical technical writing capabilities.