Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries Who Should Attend Scientists, engineers, and technicians in research and development will find this course valuable, as will quality assurance (QA), information technology (IT), manufacturing, and other operations professionals.  This course is also useful for administrative staff that must prepare documentation in support of R&D and operations activities.  Additionally, the course is helpful for anyone who wants an in-depth and comprehensive overview of the structure of the language and writing within the broad range of reporting that the industry requires. 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 Course Description Course notes and interactive exercises address how to write effective correspondence and reports in support of the company’s activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others’ writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues.   View Course Agenda Past Participant's Comments: “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, Wyeth “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, Wyeth Biopharma “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 Please Select a Location / Date Before clicking on the Register Button: The Desmond Hotel & Conference Center, Malvern, PA -- Mar. 17 - 19, 2010 -- $2250.00 The Berlin Hilton, Mohrenstrasse 30, Berlin, Germany -- Apr. 12 - 14, 2010 -- $2250.00

Certification Programs available for this Course: Certified Medical Device Compliance Professional (CMDCP)

Certified Medical Writing Professional (CMWP)

Certified Process Validation Professional (CPVP)

Current Good Laboratory Practices (cGLP) Certified Compliance Professional (GLPCP)

Current Good Manufacturing Practices (cGMP) Certified Professional (GMPCP)

Quality Systems Regulation (QSR) Certified Compliance Professional (QSRCP)

Related Courses: Introduction to Effective Medical Writing

Reporting Failure Investigations and Process Deviations

Writing Effective Standard Operating Procedures and Other Process Documents

Writing in the Regulated Environment When English Is Your Second Language

Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA