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Technical Writing in the Pharmaceutical Industry - Webinar (Recorded)

  • Webinar

  • 90 Minutes
  • September 2019
  • Compliance Online
  • ID: 4899583
Why Should You Attend:

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 often consists of SOPs and reports but may apply to any documentation written for a restricted group.

Each of us must document our activities to someone within the company. This is particularly true in a highly specialized, highly regulated field like the pharmaceutical industry. Chemists, biologists, engineers, IT personnel Each 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.

Areas Covered in the Webinar:

How to begin the process
How to collect information and determine what information is required
How to identify and receive contributions from SMEs
How to write the document
How to address comments from reviewers
How to negotiate with reviewers 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

Speakers

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.