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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Management Review – A Really Simple Task

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved January 12, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426559.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved January 12, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426559.htm….

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Wonā€™t Follow M&A Trend ā€“ Says Smith & Nephew CEO

…artificial joints have become a low-growth, commoditized business. Patients are generally satisfied with their joint replacements, especially those who receive hip implants, he noted, adding that there is not much…

…artificial joints have become a low-growth, commoditized business. Patients are generally satisfied with their joint replacements, especially those who receive hip implants, he noted, adding that there is not much…

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The Proposal: Marrying the Right Labeling Partner

By Darren Atkinson

…efficiency savings, productivity gains and increased profitability are never realized. It’s a common problem – but it can easily be overcome. The most successful companies will be those that build…

…efficiency savings, productivity gains and increased profitability are never realized. It’s a common problem – but it can easily be overcome. The most successful companies will be those that build…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Ten Days and the Clock is Ticking

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved December 16, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423254.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved December 16, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423254.htm….

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Terms of Endearment

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Imagine Thereā€™s No Receiving Inspection ā€“ Itā€™s Easy If You Try

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm….

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Not Collecting DHRs for Nine Months is an Incredible Feat for any Device Manufacturer

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Failing to Evaluate Non-Conformances is Bad Medicine

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 10, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419624.htm…

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 10, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419624.htm…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Failure to Comply With CGMPs Equates to Adulterated Products in the Eyes of FDA!

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, October). FDA.gov Website. Retrieved October 27, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418730.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, October). FDA.gov Website. Retrieved October 27, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418730.htm….

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