Wednesday, March 29, 2017

Thursday, December 8, 2016

Two candidates on Trump short list for FDA commissioner - BioCentury.com

Read the full article: Two candidates on Trump short list for FDA commissioner - BioCentury.com:

"President-elect Donald Trump's transition team has two candidates on the short list for FDA commissioner, a source on the team told BioCentury. In addition to Scott Gottlieb, a resident scholar at the American Enterprise Institute who previously has been tipped for the job, the team is considering Jim O'Neill, a managing director at Mithril Capital. That firm was co-founded by Peter Thiel, a Silicon Valley entrepreneur who was an early backer of Trump's presidential campaign. "

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Wednesday, December 7, 2016

Millennials and Compliance: Their Perspective - The Compliance & Ethics Blog

Read the full article: Millennials and Compliance: Their Perspective - The Compliance & Ethics Blog:

"Millennials who had observed serious misconduct, more than two-thirds reported it, including such offenses as theft, falsifying expense reports or time sheets, harassment or abuse, and bribery. Millennials, like any other employee, know when something is wrong, illegal, or will harm the company. They simply do not see that social media is “harmful,” any more than older employees viewed gossiping at the bar on Friday night was “harmful.”"

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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tuesday, December 6, 2016

FDA’s Draft Quality Metrics Guidance, Version 2.0 - FDA Law Blog

Read the detailed analysis: FDA Law Blog: FDA’s Draft Quality Metrics Guidance, Version 2.0:

"In conclusion, the modifications made to the revised Draft Guidance are substantial (indeed, even the name of the document was changed). It will be interesting to see whether the quality metrics reporting program, a cornerstone of FDA’s framework for building quality into drug products, advances as planned.  The path for the program over the next few years is perilous, whether the agency seeks to finalize it via notice and comment rulemaking or simply via guidance."

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tuesday, November 15, 2016

Root Cause Analysis - cGMP Free Tip

GMP Free Tip on Root Cause Analysis (RCA)

The FDA says, "Human error is not a root cause." If your first reflex is blaming human error, it's time to re-think the situation in order to identify the real root cause of the human error.

There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.

Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).

Learn more about this topic by taking these courses by SkillsPlus Intl Inc:
Root Cause Analysis for Better Investigations - A cGMP QSR GMP Training Course
Deviation Investigation Report Writing - A GMP QSR cGMP Training Workshop


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

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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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

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

 

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!