Technical Writing for Pharma, Biotech and Med Devices

Course Agenda

First Day

Regulations and Industry Standards

• Setting the foundation
  • What is technical writing and what makes it good?
  • Regulatory requirements and good business practices
  • The purpose of each document
  • How documents work together
  • Maintaining the product "thread" from document to document

Addressing the Audience

• Writing directly to the reader
• Focusing on the message
• Being technically appropriate
• Using terminology the reader understands
• Using acronyms and defining terms

Organizing Information

• Using suitable patterns to deliver effective messages
• Composing letter, fax, and e-mail messages
• Applying industry standards for effective reports
• Using document templates
• The writing process
• Writing Effective Headings
• Using Tables and Figures
• Completing the document
• Metrics: managing the process from start to finish
• Formal Review

Writing Effective Passages

• Understanding the function of specific passages
  • To describe
  • To compare and contrast
  • To define
  • To show cause and effect
  • To show sequence
  • To summarize
• Writing clear topic sentences
• Giving enough information to convince
• Referencing other writers

Second Day

Controlling the Language

• Conventions of the English language
• Writing grammatically sound sentences
• Combining and subordinating information
• Making every word count
• Using transitions

Using the Right Tense and Voice

• The writer's voice
• Remaining objective
• Using the subjunctive, imperative, and emphatic voice
• Using the active voice
• Paring the passive

Punctuating Effectively

• Using punctuation to clarify messages and improve readability
• Bullets, numbers, white space
• Using symbols and abbreviations

Writing Workshop

• The writing process
• Describing a mechanism
• Revising and fine tuning

Third Day

Writing Workshop

• Achieving clarity and readability
• Assessing your own writing
• Making every word count
• Participants' writing concerns

The Writing Environment in Industry

• Writing in the industry over time
• Projections for documentation practices

Learning Objectives

Upon completion of this course, you will:

• Understand the mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
• Know how the reporting process supports products in research, development, and the marketplace
• Understand how documents work in tandem from initial correspondence about a project to an approved protocol, amendments, and final study report
• Know how to produce effective written correspondence
• Understand how to assess and write to the audience
• Know how to organize and deliver information based on the message
• Understand how to structure reports
• Understand the innate structures of English grammar
• Know how to create grammatically sound passages
• Understand how the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
• Have a working knowledge of punctuation marks and their role in making documents readable
• Know how to review and revise documents
• Understand your own writing patterns and know the answers to your questions about the English language
• Have increased confidence in writing and revising documents

Testimonials

"The course was very informative and the instructor allowed time to share ideas and real world issues encountered in our industry. I found the material provided very helpful." Sherrie S., Document Control Spec. Mallinckrodt

"Perhaps the best course I've attended! The course director is extremely well-versed in the subject matter and also an excellent lecturer. The information was presented very well and followed by useful exercises. The exercises kept the engagement level high and the pacing was perfect." Nora P., QA Validation Mgr, bluebird bio

"The instructor was phenomenal!!! Material was presented in an understandable and interesting way and the supplemental info was very useful." AS Engineer, SHL Pharma

"The instructor was very knowledgeable, friendly and engaged the audience well." Mario N., AS Intern, SHL Pharma

"The course was very interactive and hands on. We were able to ask questions and present scenarios that we were struggling with and get personalized help. Keep up the good work." Manda, W., Support Documentation, ALK Source Materials

"This course was far better than courses I’ve taken with other training providers. The instructor presented the material well, stayed on topic and kept the class engaged." Stephanie A. Quality Assurance Analyst, Penumbra

"This course was well structured and a good balance between lecture and exercises." Petra K. Scientist, uniQure

"The course was fantastic! The presenter was very knowledgeable, and the material was extremely organized and informative. Her communication skills were excellent to present such a difficult subject." Marta M., Quality System Manager, Biotest

"The instructor was very knowledgeable and the class size allowed us to discuss real scenarios." Pam E., Senior Project Administrator, C.R.Bard

"This is the third consecutive course I've taken with CfPIE over the last three years. I have yet to be disappointed! The Course Director was great and I'll definitely use what I learned in my job." Saritha D., Sr. Regulatory Specialist, Pfizer

"I very much enjoyed the instructor's methods for coordinating this course. She was extremely knowledgeable on the subject material and was proficient in relaying the course information to the class. I believe that my experience from this course will enhance my ability to review/edit documents in a corporate atmosphere, as I will take the information that was presented to me and use it in conjunction with my prior experiences and knowledge. Thank you!" Chris O., Analyst, Celgene

"The material was very well-organized and struck a good balance between lecture and exercise. The organization from micro to macro was a good way to structure the focus of the course so that concepts build on themselves." Matt B., Supervisor, QC Chemistry, Celgene

"You presented the course material in a clear and concise manner. Thank you for keeping it interesting." Maricela C., Sr. Analyst, Celgene

"This course was one of the most thorough and informative I have taken. I will apply what I have learned to my report writing from now on." Stephen B., Scientist, Merck

"I always thought of myself as a decent writer, but this course got me thinking about my control of the language. It made clear the different voices to use in writing. It taught me to reflect on what I write and think about the trial audience." Alyssa M., Associate Scientist, Merck

"The instructor was very engaging. The course information she presented will be helpful to me in my current position and future endeavors. I would recommend the Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries course to anyone who does any writing, whether manager or technician." Jon C., Sr. Manager of Quality/Development, Scholle Chemical

"I really enjoyed this course. It provided very useful information to help me improve my writing and recognize and correct problems in documents I review for others. The instructor was quite knowledgeable and open to sharing her love of language. This was so refreshing in a world becoming so casual in communication, especially the written word." Rick J., Document Management Specialist, Fujifilm Diosynth Biotechnologies

"This course was to the same high standard that I find refreshing and I appreciate that all courses are excellent. I hope to use your company again and would recommend your courses to colleagues and co-workers." Rachal McK., Compliance Professional, Allergan Pharmaceutical Ireland, Botox Facility

"I have learned a lot from the Course Director. A very helpful person and explained things very well. I would love to do the SOP Writing course and many more courses with CfPIE." Catherine H., Document Specialist, Pfizer

"Outstanding course and an outstanding presenter. The course director did a great job." Tim A., Engineer, Guidant

"The course director did a very good job. This course helped me to realize many things that I do while I write. I now have tools to change some of them. The course director's way to teach and talk about writing was very different and unusual for me. It makes me think and ask myself good questions. Good job! Even the food was good and all was well planned and organized. Great!" Marie F., Technical Writer, Institut Rosell-Lallemand

"The modules and hands-on experience were very helpful. The course director's knowledge in the industry was also great." Maria R., QA Associate, Alza

"The Course Director has a complete knowledge of the subject. I enjoyed it tremendously and I look forward to more trainings with her." Camille S., Staff Engineer, Cordis

"I really enjoyed this course. As English is not my native language, it was very useful to refresh on grammar I had learned many, many years ago. In addition, the Course Director covered topics on writing for regulatory submissions, which is very relevant to my current work. I also found her encouraging, because she stated that writing is a skill you can learn, not a talent. This gives me hope that one day I will master English and technical writing. Thanks!" Cyorgyi T., Senior Scientist, Intercytex Manchester, UK

Frequently Asked Questions

When writing a GLP study report, can we copy the study plan from the protocol and insert it into the document?

Many companies "cut and paste" from the protocol, but without adjustment in tense, they risk creating confusing documents. The protocol reflects what a company plans to do; the study report tells what happened during the study and what the outcome is. Thus, it's important that the study report describes the plan in the past tense, not the future, reflecting what has already occurred.

We believe we are always objective in our CAPA summaries when stating what happened, but FDA cited our documentation for being unclear in who did what. How can we be more precise?

There is a conception that scientific writing must be in the passive voice to be objective, but in certain types of documentation, such as CAPA summaries, the passive voice can permit the omission of critical information. Consider the following:

A package of X was returned to the retail point of purchase. Via telephone, the package was reported to contain loose white powder with the tablets, and the package was sent back to manufacturing the following day.

Using the active construction necessitates an agent of action, and there's no doubt as to who did what.

A pharmacist reported, via telephone, that a customer had returned a package of X because of loose white powder with the tablets in the package. The call center requested return of the package, and the pharmacist shipped it the next day.

So much of what we write involves comparisons between test groups, but our comparisons don't seem as clear as they should be. How can we improve?

Making comparisons and assessing variations and differences are integral to the development of most therapeutic products. Where writers frequently fall short is failing to compare the right things. Consider this sentence: Residue in the liver of the hamster was greater than in the rat. A sentence like this says that the comparison was between residue in liver of the hamster and residue in the entire rat. An easy fix is to recast such a sentence as follows: Liver residue was greater in the hamster than in the rat. Here's another example of the same sort of illogic: The results of this study are similar to the last study. Careful writers compare results to results, as in the following sentence: The results of this study are similar to those of the last study.