Good communication is a hallmark of trust. If people know they can count on you to communicate well, to articulate thoughts in ways that are understandable to any listener, then people will see you - and the programs you champion - as worth paying attention. And when it comes to dealing with the FDA or the EMA or Health Canada or any other regulatory agency, communications speak volumes about the levels of trust and competence that regulatory authorities should assume about you.
Three tips to elevate your communications when it comes to regulatory compliance and quality systems:
- Equate email with image. Think of email as tiny bits of a virtual company image. At a minimum, use spell check (but don't rely solely upon it), keep the number of recipients to a minimum, do not flag items as urgent or high priority if they really aren't, and understand that email is not private. As a colleague once put it in a training session, "Don't put anything in your email that your mother would be ashamed of reading in tomorrow's New York Times."
- Readability of memos and emails. When it comes to memos, use your word processing program to check for the ease of comprehension (e.g., readability). Microsoft Word, for instance, will allow you to check readability levels when you check spelling and grammar. But when it comes to emails, you'll need to do the work, so some rules to keep in mind: anything more than 3 paragraphs will encourage skimming so be cautious; when you can, number items rather than bullet point them; keep lists to under 5 items; and make sure to read through any email to a regulatory agency or your boss (at minimum) to ensure you've not inadvertently left out a word or two (something we're all guilty of occasionally).
- Visit in person. Know when to write, call, or visit. If you're having trouble picking just the right words or phrases to use to avoid misunderstandings, that's the signal to step away from the computer and go talk to someone in person or on the phone.
The news is full of pharmaceutical and device firms who've gotten sued or otherwise involved in litigation, and have been forced to divulge their emails and internal business communications. Don't join in. Use these tips to help you think twice about recording comments and phrases that might later be taken out of context and used to portray you or your company in a negative, uncaring light.
For more advice you can use on controlling records and handling requests from FDA for records or emails, see my recorded seminar, FDA Quality Systems Records Requirements and Retention for Pharmaceutical, Biotech, and Device Firms - GLPs, GCPs, GMPs, QSRs. You get a 9-page matrix detailing out various retention requirements under each regulation along with loads of tips and advice on how to build in retaining the right records to prove compliance and product safety, efficacy, and quality.
And if you need more advice, feel free to contact me directly.