MedTech I.Q.

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January 2019 Blog Posts (7)

How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the…

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Added by Adam Fleming on January 30, 2019 at 7:07am — No Comments

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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Added by John Robinson on January 23, 2019 at 5:51am — No Comments

Active Substances and Excipients for Medicines - Rules and Requirements

Quality Assurance, Quality Systems, quality risk management and Quality Control are the cornerstones of Good Manufacturing Practices (GMP). Being a globally acclaimed provider of training courses for professionals, Traininng.com introduces these concepts at this online regulatory compliance training webinar.

The expert, Dr Madeleine S. Fairweather, will present these concepts in accordance with EU GMP Part II. However,…

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Added by Joseph Wilcox on January 18, 2019 at 7:29am — No Comments

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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Added by John Robinson on January 18, 2019 at 5:16am — No Comments

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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Added by John Robinson on January 9, 2019 at 6:44am — No Comments

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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Added by John Robinson on January 7, 2019 at 7:28am — No Comments

6-Hour Virtual Seminar on FDA's Software Monsters

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction.  The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern.  Part of that risk involves the intentional activity that can conflict, intrude or destroy software.  The problems are taking center stage in the “healthcare software” dialogue.  What issues can compromise or defeat the…

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Added by John Robinson on January 2, 2019 at 5:58am — No Comments

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