The Six Questions Every L&D Professional Should Ask Stakeholders To Identify Business Needs – eLearning Industry

According to the article, there are 6 questions to ask:

  1. What is the training need? (What has driven this request?)
  2. What are the desired outcomes? (What does success look like?)
  3. Who is the target audience?
  4. What should they (the target audience) be doing?
  5. How will we measure success?
  6. What Might Enable or Derail the Success of the Solution?

Read the full source article: The Six Questions Every L&D Professional Should Ask Stakeholders To Identify Business Needs – eLearning Industry

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Medical Device Tax Is History After Trump Signs Repeal – BioFlorida

According to the article:

“The medical device industry hailed President Trump’s signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade.

The 2.3% tax on medical device sales that is part of the Affordable Care Act has already been on temporary hiatus since the beginning of 2016, but was scheduled to return at the end of this year if Congress didn’t eliminate the tax or put it on hiatus once again.”

Read the full source article:  Medical Device Tax Is History After Trump Signs Repeal – BioFlorida

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GMP Training – Courses taught by SkillsPlus Intl Inc.


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FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

“The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act (FD&C Act).

The SSM will use risk factors consistent with section 510 of the FD&C Act, which identifies specific risk factors and allows FDA to determine additional ones, including: “a) The compliance history of the establishment. b) The record, history, and nature of recalls linked to the establishment. c) The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.””

Read the full source article: FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

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“Mutual Recognition” Kicks Into High Gear – FDA Law Blog

Stethoscope and books

“On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.”

Source: FDA Law Blog: “Mutual Recognition” Kicks Into High Gear

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