The responses that organizations give to the FDA when they need to interact with it have to be very precise, technical and scientific. They are a test of the writing skills of the writer who frames these responses. The answers have to be very carefully weighed. Responses to the FDA have to be more loaded and impactful than being creative or artistic.
The power of persuasive and precise writing comes into play when organizations have to defend their actions in relation to the method or process they adapt for developing new drugs or when it comes to responding to FDA citations and other documents. When negotiating with the FDA; the organization has to have very strong and robust responses, which will go a long way in convincing the FDA about the veracity of the intent behind many of the organization’s actions.
These skills can be learnt
These writing skills can certainly be learnt. Documentation that is legally coherent and convincingly written has the ability to go beyond documents that are just well written in passing the FDA hurdle. The ways of doing this properly and effectively will be the learning that a webinar from Compliance4All, a well-known provider of professional trainings for all the areas of regulatory compliance, will be offering.
At this webinar, at which Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com will be the speaker, learning will be offered on a variety of methods by which legal writing can be tightened and compacted. To enroll for this webinar, just log on to http://www.compliance4all.com/control/w_product/~product_id=501030
At this valuable learning session, Michalik will cover the following areas:
o Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations
o Step-by-step analysis of how to present both good and poor data in a persuasive manner
o How to train scientists and engineers to generate “good” data to support legal, regulatory and quality claims?
o Tips and secrets to framing an argument that makes even poor data look good
o Examples of good writing that can be useful templates for training and skills development
o What you should never say in a quality or regulatory document?