Technical Writing for Pharma, Biotech and Med Devices

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

Regulations and Industry Standards

• Setting the foundation

1. What is technical writing and what makes it good?
2. Regulatory requirements and good business practices
3. The purpose of each document
4. How documents work together
5. 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

1. To describe
2. To compare and contrast
3. To define
4. To show cause and effect
5. To show sequence
6. To summarize

• Writing clear topic sentences
• Giving enough information to convince
• Referencing other writers

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

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

"This course had a great flow and was exactly as expected!  The instructor was wonderful! She made engagement easy and enjoyable, and the material was presented in a great manner with wonderful resources and application."

Brittany K., Manager-Quality Validation, Sanofi

"The course director was knowledgeable and ran the class very efficiently. I enjoyed the class, and she made the learning 'fun'!  I feel the course covered all the topics effectively."

Janet, C., Documentation Control and Training Manager, Curis

"The course director's level of professionalism and knowledge far surpassed other training sessions I have attended.  I found the group exercises very beneficial. Using the handouts and examples allowed our team to practice our skills in real time, and ask for help when needed."

Sara R., Manufacturing Specialist, Catalent

“This course was excellent and exceeded my expectations. The instructor was highly knowledgeable with a lot of experience in the industry. This writing class was one of the fourth consecutive courses I've taken with CfPIE over the last three years, and will complete my GLPCP certification. Thank you for offering the certification programs.  I enjoyed every detail of this class. There was lots of helpful information in addition to that on the slides. Thank you for the handout pack , it was awesome . I can’t wait to share new techniques learned with my coworkers.”

Laurentine S., GLP Associate, Henry Jackson Foundation

"This course was fantastic! The content and handouts addressed all the topics that I was interested in.  The Course Director is an excellent instructor. She took the time to address areas of concerns, interacted with everyone, and supplied additional information. I really enjoyed this course."

Sabrina D., Scientific Writer, Carisma Therapeutics

"Compared to other courses this was the best ever. The course director tried to communicate with attendees and provided various course materials.  I enjoyed meeting people in the same field from other countries."

Min H., Quality Asst. Mgr., UPPTHERA

"The trainer was knowledgeable and experienced.  The interactive sessions were helpful in application of the course materials."

Amelia T., Associate Director, Safety Analysis Scientist, Janssen

"Content was very applicable to everyone attending and was interactive even though the subject matter isn’t exciting. The instructor was great, and the practical examples were very useful."

Aleks P., Senior Manager, Regulatory Affairs, Aurinia Pharmaceuticals

"Probably the best course I’ve ever taken. Really useful information!"

Neil S. Quality Assurance, Boston BioProducts

"The course was amazing! It managed to keep everyone engaged throughout. I’m not normally not a fan of group exercises but this was the best part of the course as getting your hands dirty and actually working on relatable writing issues helped a lot."

Katrina G., Clinical Trial Disclosure Associate., University of Miami

"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

"I enjoyed the instructor’s teaching style and working in groups. She made sure we understood the material and is very knowledgeable."

Natacha I., QA Auditor., University of Miami

"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