Technical Writing in an Industrial Environment
Product ID : ROBP-0004
Level : Beginner
Duration : 60 Minutes
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.
The webinar will describe a process to create quality documents from a blank screen in a timely manner. The process is logical and easily understood. The process describes the location and collection of important information. The process describes how to organize the information collected into a document. The webinar also addresses how to write the document and address comments received from reviewers and approvers.
Technical Writing differs from general writing in that Technical Writing is written for a highly specialized audience. The Technical Writer markets their ideas or defends the work to another person who may or may not appreciate your efforts. The Technical Writer taught to be aware that they know more about the subject matter than anyone else. That is particularly true if he/she did the work. That is even if someone else did the work because the Technical Writer is the only one who sees the collective efforts of everyone involved while others only see their individual contributions.
Technical Writing is the collection of all ideas, concepts, and comments related to the original assignment made by your supervisor. Technical writing must be balanced enough so that the highly technical audience will understand and appreciate what is said but Technical Writing must also be understood by an audience who may not be as well-versed in the subject matter as other members of the audience. Usually, Technical Writing consists of reports and/or Standard Operation Procedures (SOP's) but can also include Instruction Manuals.
Technical Writing in an Industrial Environment differs from general correspondence in that it is written for a specific audience. Technical Writing in an Industrial Environment often consists of Standard Operating Procedures (SOP's) and reports but may apply to any documentation written for a restricted group.
The webinar will address all of these issues.
- 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 appreciate and address comments from reviewers/approvers
- How to negotiate when disagreements arise between reviewers/approvers
- How to incorporate comments into the final document
- How to obtain comments in accordance with required timelines
- Final approval of the document
Course Level - Basic
Who Should Attend
- IT personnel
- Any highly technical
- Highly specialized personnel
Why Should You Attend
Scientists, engineers, IT personnel and statisticians among other highly technical specialists may find writing documents in an industrial environment 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.
You should attend this webinar because everyone will have to provide written presentations at some point during their careers. This webinar will provide an overview of the process to create documents in an industrial environment. The process will be presented in an easily understood format that attendees can easily apply to their daily tasks.