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John Robinson
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  • Fremont, CA
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How to interpret and use more than just a standard tool-box

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical…
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Posted on January 23, 2019 at 5:51am

eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review…

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Posted on January 18, 2019 at 5:16am

Effective Technical Writing in the Life Sciences

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the…

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Posted on January 9, 2019 at 6:44am

How the FDA interprets advertising and promotion in principle and in fact

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…

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Posted on January 7, 2019 at 7:28am

Comment Wall (1 comment)

At 7:53am on August 29, 2017, Sandra Essien said…

Good Day,

How is everything with you, I picked interest on you after going through your
short profile and deemed it necessary to write you immediately. I have something
very vital to disclose to you, but I found it difficult to express myself here,
since it's a public site.Could you please get back to me on:(
mrs.sandraessien@yahoo.com) for the full details.

Have a nice day

Thanks God bless.

Sandra Essien

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