Technical writing in the Pharmaceutical Industry is a highly specialized field. Technical writing differs from general correspondence in that it is written for a specific audience.
Technical writing is a balancing act between being precise enough to cover the subject matter yet general enough to apply to other situations and/or projects. It often consists of Standard Operating Procedures (SOPs) and reports but may apply to any documentation written for a restricted group. Technical writing always includes reviewers.
Learning Objectives:
- Understand how technical writing differs from normal correspondence
- Guidance on how to go from a blank screen to a complete written document
- Gain insight into in-house templates/outlines/procedures and their relationship to your document
- Learn some techniques to write the document
- Learn how to address comments from reviewers
- Final approval of the document
Why Should You Attend:
Chemists, biologists, engineers, IT personnel and statisticians among other highly technical specialists may find writing documents to be a challenge. Join this webinar to gain valuable insight into how to address this challenge. Learn techniques to communicate contributions and ideas developed to stakeholders.
Topics
- How to begin the process
- How to collect information and determine what information is required
- How to identify and receive contributions from Subject Matter Experts (SMEs)
- How to write the document
- How to address comments from reviewers
- How to negotiate when disagreements arise between reviewers
- How to incorporate comments into the final document
- How to obtain comments in order to address timelines
- Final approval of the document
Instructor
After obtaining a B.S. and an M.S. in Chemistry from Tuskegee University, Robert Peoples joined the pharmaceutical industry as a Research Chemist with a concentration in analytical chemistry at Wyeth/Lederle. While at Wyeth/Lederle Robert was primarily responsible for the analysis of the Active Pharmaceutical Ingredient (API) in various drug delivery formulations, e.g. aerosols, capsules, creams, ointments and tablets. He joined Organon/Merck as a Research Chemist responsible for the development of stability-indicating methods of analysis using HPLC.
While at Organon/Merck, Robert transitioned into technical writing. As a Technical Writer he was responsible for the creation of procedures for instrument qualification, test scripts, IQ/OQ/PQ protocols for sample handling, cleaning validation reports, method transfer reports, method validation reports, stability reports, Change Control and CAPAs.
Later he joined Johnson and Johnson as a Technical Writer where he created stability strategies, protocols and reports as well as SOPs, developed training materials and competency profiles in addition to proofreading and improving written reports for other departments. He also edited policies and procedures, user guides, and job aids.
After leaving Johnson and Johnson Robert became a consultant to other pharmaceutical companies where he created SOPs for analytical method validation as well as pharmaceutical stability studies and stability program management.
For another client company he created stability reports that addressed FDA concerns about OOS/OOT results. For yet another client company he created stability reports, protocols and strategies for medical devices. He also created written assessments for software-controlled laboratory instrumentation.
Robert also has extensive experience in data review, stability management and training.