GMP Basics for Beginners & Experienced Team Members - cGMP Training Course

• FDA cGMP QSR GMP Training - online training classes taught by SkillsPlus International Inc.

cGMP Basics Training Course for Beginners, and Experienced Professionals

Naturally you'll want your new hires introduced to the basics of the FDA cGMP regulations.

Don't forget that your experienced team members need occasional doses of GMP refresher training too!

You might be interested in our cGMP training course:

 
"Essentials for Pharmaceutical Manufacturers."

GMP training for beginners and experienced team members

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cGMP training for beginners and experienced professionals

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!

 

8th Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - U.S. - mondaq.com

Read the full article: Eighth Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - United States - mondaq.com:

"Judges Murphy and Gruender explained, RCO liability bears on the blameworthiness of a corporate officer who failed to prevent or remedy the condition at issue. And any executive operating in the highly regulated world of food and drugs, where widespread harm can be the outcome of corporate negligence, has a “heightened degree of foresight and care.”"

'via Blog this'

RCO = responsible corporate officer

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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!

 

FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law

Read the full article: FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law:

"Effective August 1, 2016, FDA investigators now will make a preliminary assessment regarding a compounder’s compliance with conditions of section 503A and will not include observations that represent deviations solely from CGMP requirements unless the investigator’s assessment is that the compound drugs do not qualify for the exemptions under section 503A."

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Read the details of the FDA Notice (PDF)

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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!

 

FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

• Recommended FDA cGMP online training courses, classes, and programs sold by SkillsPlus International Inc.

Updated October 8, 2022

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Human Drug Compounding - FDA.gov

---  the original post follows below  ---

Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

'via Blog this'

Read the details of the FDA Notice (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!