Technical Writing for the Pharmaceutical Manufacturing Industry
Date : 25 February 2019
Time : 02 : 00 PM EST
Duration : 60 Minutes

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective.

Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

Personnel in Pharmaceutical manufacturing will be asked to review many different documents. These documents are important, in that, it will be scrutinized by regulatory bodies. The aspects of writing these documents are different. The style of writing is more reader-centric, as opposed to writer-centric. Understanding the aspects of reader-centric writing is important in this industry.

  • Provide information on the various documents within the Pharmaceutical Manufacturing Industry
  • Discuss the format of various documents within the Pharmaceutical Manufacturing industry
  • Discuss the concepts the writer must keep in mind when writing a technical document
  • Discuss any regulatory requirements and what regulatory bodies are looking for when reviewing technical documents
  • Why the review process is important
  • Provide examples of documents reviewed by regulatory bodies and discuss key points of those documents.

Learning Objectives

  • The Pharmaceutical manufacturing industry is a very different industry, it is not a study in creative writing. It is an industry that is based on providing fact-based evidence and developing a sound scientific conclusion based on that evidence.
  • Understanding how to write for the industry is an art, there are few courses that teach how to write for the industry. It is mostly up to the writer to develop a style and technique that is appropriate for the industry.
  • This course is not an extensive writing course, but an introduction to the documents, various formats, and how to develop the writing component that is needed for the Pharmaceutical Manufacturing industry.
  • Various example documents will be discussed: Investigations (deviations and other quality system documents), facility reports, environmental monitoring reports, validation reports, validation protocols, etc.
  • What to look for when reviewing documents

Who Should Attend

  • Quality Assurance
  • Validation
  • Quality Control
  • Auditors
  • $179.00