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. "

'via Blog this'

Return to SkillsPlus International Info Blog - Home

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!

 

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

• FDA GMP Online Training - recommended CGMP online training courses provided by SkillsPlus International Inc.

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.”"

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training

 

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"In conclusion, the modifications made to the revised Draft Guidance are substantial (indeed, even the name of the document was changed).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."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

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!

 

FDA finalizes quality guidelines for contract manufacturers | BioPharma Dive

Read the full article: FDA finalizes quality guidelines for contract manufacturers | BioPharma Dive:

"In its 16-page document, FDA also explains that Current Good Manufacturing Practice (CGMP) requirements apply to all contract facilities, including analytical testing labs."

'via Blog this'

View the published guidance document:
Contract Manufacturing Arrangements for Drugs: Quality Agreements - FDA Guidance for Industry (PDF)

Return to SkillsPlus International Info Blog - Home

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!