Thursday, October 20, 2016

Emerging Issues and Cross-Cutting Scientific Advances - FDA; Establishment of a Public Docket - Federal Register

Go to the full notice: Federal Register :: Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket - FDA:

"The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years."

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Tuesday, October 18, 2016

FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews

Read the full article: FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews:

"The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest."

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View the draft guidance:
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability

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Monday, October 3, 2016

Paula Marks Joins The SkillsPlus International Inc. Training Team

Paula Marks, M.S. - SkillsPlus International Inc. Certified Trainer
Paula Marks - SkillsPlus Intl Inc. Certified Trainer
SkillsPlus Intl Inc. - Paula Marks joins the training staff at SkillsPlus International Inc.

SkillsPlus International Inc. is excited to add Paula Marks, M.S. to our training staff. Ms. Marks has practical and management experiences in various pharmaceutical, biotechnology, cell-therapy, research and development, and medical device/IVD companies. A SkillsPlus Intl Inc. certified trainer since 2007, Ms. Marks brings a personal rapport and commitment to her cGMP and deviation investigation training sessions.

Please join us in welcoming Paula to our team.

Learn more:  About Us - SkillsPlus International Inc.

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - Advanced GMP Training
Deviation Investigation Report Writing - Advanced GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!