Process Control… RFID has it Under Control

By Rick Raber, Angela Hoffman

…system for a less complex, quick running and cost-effective operation. The RFID integrator took the design specifications and utilizing their engineering and manufacturing departments, sourced the components and created an…

…system for a less complex, quick running and cost-effective operation. The RFID integrator took the design specifications and utilizing their engineering and manufacturing departments, sourced the components and created an…

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

Part Three – Production Controls “What’s the Point?”

By Dr. Christopher Joseph Devine

…of process parameters and component and device characteristics during production; Compliance with specified reference standards or codes; The approval of processes and process equipment; and Criteria for workmanship which shall…

…of process parameters and component and device characteristics during production; Compliance with specified reference standards or codes; The approval of processes and process equipment; and Criteria for workmanship which shall…

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Medical Technology To Go

…were interested in the topics presented by COMPAMED. For information on visiting or exhibiting at COMPAMED or MEDICA 2014, contact Messe Düsseldorf North America via email: info@mdna.com or visit http://www.mdna.com….

…were interested in the topics presented by COMPAMED. For information on visiting or exhibiting at COMPAMED or MEDICA 2014, contact Messe Düsseldorf North America via email: info@mdna.com or visit http://www.mdna.com….

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

Data Falsification – Part Duex

By Dr. Christopher Joseph Devine

…guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. FDA’s enforcement page. (2014, May). FDA.gov Website. Retrieved June 4, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm399011.htm….

…guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. FDA’s enforcement page. (2014, May). FDA.gov Website. Retrieved June 4, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm399011.htm….

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Reimbursement Report

Let’s Start at the Very Beginning

…after the diagnosis. In the case of competing technologies, payers may want a head to head comparison of the two technologies, particularly if the new technology claims to be better…

…after the diagnosis. In the case of competing technologies, payers may want a head to head comparison of the two technologies, particularly if the new technology claims to be better…

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

Data Falsification

By Dr. Christopher Joseph Devine

…into the CAPA system can come from: (a) manufacturing operations; (b) audit reports (internal, external, and supplier); (c) customer complaints; (d) management review meetings; (e) other non-conformances, e.g., product or…

…into the CAPA system can come from: (a) manufacturing operations; (b) audit reports (internal, external, and supplier); (c) customer complaints; (d) management review meetings; (e) other non-conformances, e.g., product or…

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Montana Cherney, Creative Director, Veryday

The User-Driven Transformation of Health Care

In the face of new potentials and new demands in the health care space, as well as the digitization of daily life, the health care industry is feeling significant pressure…

In the face of new potentials and new demands in the health care space, as well as the digitization of daily life, the health care industry is feeling significant pressure…

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

Failure to Establish and Maintain

By Dr. Christopher Joseph Devine

…simplified approach for complying with 21 CFR, Part 820.50. Simply stated; “there is no such thing as minimum compliance and no such thing as maximum compliance; there is just compliance.”…

…simplified approach for complying with 21 CFR, Part 820.50. Simply stated; “there is no such thing as minimum compliance and no such thing as maximum compliance; there is just compliance.”…

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Ask the Engineer

Ask the Expert: Solutions that Cure

…of concern? A: When companies are facing Sustainability Initiatives that involve using safer materials, Henkel has adhesives solutions that can accommodate bonding these new alternatives. Henkel Medical Adhesives can bond…

…of concern? A: When companies are facing Sustainability Initiatives that involve using safer materials, Henkel has adhesives solutions that can accommodate bonding these new alternatives. Henkel Medical Adhesives can bond…

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

Performing Quality Audits is not Optional

By Dr. Christopher Joseph Devine

…CAPA system. However, documented evidence of compliance better be in the form of an audit schedule supported by audit agendas and sign-in sheets. As a minimum, Dr. D recommends the…

…CAPA system. However, documented evidence of compliance better be in the form of an audit schedule supported by audit agendas and sign-in sheets. As a minimum, Dr. D recommends the…

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