Category: TRA360 Blog

FDA Basics for Industry

Posted on by Valentina Rosa

The FDA has launched a new web site called FDA Basics for Industry to help companies save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that is frequently requested by industry. According to FDA Commissioner Peggy Hamburg, “the goal [of FDA Basics for Industry] is to improve communication between FDA and industry by making basic information about the regulatory process more accessible and user friendly to industry.”

This short video should be of value to any professional in the regulatory writing, regulatory consulting, or medial writing fields.

Minimalist Writing

Posted on by Valentina Rosa

Minimalist writing has been around for almost 20 years. The minimalist movement started with John Carroll’s book The Nurnberg Funnel: Designing Minimalist Instruction for Practical Computer Skill published in 1991 by M.I.T. Press. (1)

For many professionals who may their living as technical writers or technical communicators, this book forms an essential foundation in writing quality technical documentation. Carroll’s approach is to focus technical documentation on how users work, not how the system works. Or, to put it differently, focus on tasks users will perform with a system (hardware, software, service, or any combination) and not on the features of the product. Carroll presents significant research to support his argument and also provides examples in the texts to illustrate his points.

Technical writers who need to reduce the volume and complexity of their content should read Carroll’s book. It will help you to reduce the cost to develop, produce, and maintain technical documentation. It will also demonstrate ways to decrease the time and effort needed to work with content and improve the quality of your deliverables.

Anyone who is charged with writing documentation should read this book. It will change your point of view and your readers will love you for it.

Notes

(1) M.I.T. Press published a related book, Minimalism Beyond the Nurnberg Funnel, in 1998.

Resources

The EServer Technical Communication Library

Where to go for more minimalist information

William Strunk, Jr. and E.B. White, The Elements of Style

Pfizer Goes It Alone on Social Media

Posted on by Valentina Rosa

I wrote a blog post on December 22 entitled “FDA Misses Own Deadline On Social Media.” Some Big Pharma companies like Pfizer are defining their own rules rather than waiting for the agency to deliver their guidance in the first quarter of this year. According to an article on BNET by Jim Edwards, Pfizer has just developed its own social media playbook along with a blog response flowchart based on a version used by Pfizer Canada that was originally developed by the U.S. Air Force in December, 2008.

Edwards said that Kate Bird, Pfizer’s digital communications strategy director, said “Twitter is really the most-used channel for any type of crisis communication.” She indicated that the playbook was introduced because “We don’t want them to be intimidated and afraid of it. It’s part of our everyday life. It’s only going to become an even greater part of our everyday life.” (1)

While Pfizer’s playbook and flowchart aren’t rocket science, it does show that Big Pharma is moving forward with social media without the FDA. And Pfizer’s not alone or the first to do so. Roche created its own social media playbook in August 2010.

Notes

(1) Pfizer Goes on Facebook Offensive With “Social Media Playbook” and Blog Response Flowchart

Resources

Pfizer Goes on Facebook Offensive With “Social Media Playbook” and Blog Response Flowchart

Pfizer Canada shares its social media response flow chart

The Air Force’s Rules of Engagement for Blogging

The surprising truth about what motivates us

Posted on by Valentina Rosa

Elliott Lemenager has started following me on Twitter. I’m not sure how he found me and why my posts interest him. (I sent him a direct message to find out. If he replies, I’ll update this post.)

Elliott’s an interesting character. According to his blog, he writes to “give insight into my social media/environmental efforts” and founded Phoenix Local Music. In his day job, Elliott is an Online Community Manager for Microsoft’s Startup Business Group (SBG). He’s active in social media on professional and personal levels, and is also committed to CleanTech/GreenTech.

Elliott recently posted Dan Pink’s RSA Animate video entitled “Drive: The surprising truth about what motivates us.” It’s an informative, entertaining, and creative video, even though I got a bit dizzy from the hyperspeed writing on the whiteboard.

The video is almost 11 minutes and Elliott recommends watching it all and I agree. However, if you can’t watch the whole piece, he says to watch 6:44 min in. I disagree. Start watching at 5:05 min. In my opinion, the discussion about what motivates people and provides the most personal satisfaction—autonomy, mastery, and purpose—are the best part.