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The Regulatory Compliance Experts
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Global Unique Device Identification Database (GUDID) | GxP Systems
https://gxpsystems.wordpress.com/2014/10/20/global-unique-device-identification-database-gudid
The Regulatory Compliance Experts. New FDA Guidance Modifies 510(k) Rules. Searching for Engineers – Quality over Quantity →. Global Unique Device Identification Database (GUDID). October 20, 2014. In September 2013, the FDA published the Final Unique Device Identifier (UDI) Regulation, which we discussed in detail in one of our earlier blogs. A UDI is required to appear on the label of every medical device and every device package unless exempt. This includes combination products that contain a devi...
Final Rule from FDA on Infant Formula Current Good Manufacturing Practices | GxP Systems
https://gxpsystems.wordpress.com/2014/08/29/final-rule-from-fda-on-infant-formula-current-good-manufacturing-practices
The Regulatory Compliance Experts. Drug Supply Chain Security Act Implementation: Draft FDA Guidance. New FDA Guidance Modifies 510(k) Rules →. Final Rule from FDA on Infant Formula Current Good Manufacturing Practices. August 29, 2014. The final rule in full can be found here. In our next blog, we will discuss a demonstration of the Quality Factor Requirements under 21 CFR 106.96 for eligible Infant Formulas. View all posts by GxP Systems →. This entry was posted in Industry News. Enter your comment here.
Drug Supply Chain Security Act Implementation: Draft FDA Guidance | GxP Systems
https://gxpsystems.wordpress.com/2014/08/27/drug-supply-chain-security-act-implementation-draft-fda-guidance
The Regulatory Compliance Experts. Expedited Access Program for Certain Medical Devices – Part 5. Final Rule from FDA on Infant Formula Current Good Manufacturing Practices →. Drug Supply Chain Security Act Implementation: Draft FDA Guidance. August 27, 2014. In June 2014, the FDA published a draft guidance intending to aid manufacturers, re-packagers, distributors or dispensers in identifying a suspect product and terminating notifications regarding illegitimate products. With effect from 1. The guidanc...
October | 2014 | GxP Systems
https://gxpsystems.wordpress.com/2014/10
The Regulatory Compliance Experts. Monthly Archives: October 2014. Global Unique Device Identification Database (GUDID). October 20, 2014. In September 2013, the FDA published the Final Unique Device Identifier (UDI) Regulation, which we discussed in detail in one of our earlier blogs. UDI initiatives also are underway globally; the European Commission released a framework for a UDI System … Continue reading →. Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.
Program Management: some useful tips | GxP Systems
https://gxpsystems.wordpress.com/2015/03/09/program-management-some-useful-tips
The Regulatory Compliance Experts. Searching for Engineers – Quality over Quantity. Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities →. Program Management: some useful tips. March 9, 2015. On how to successfully manage an engineering program. Learn successful conflict resolution quickly! The fact that conflict exists, however, is not necessarily a bad thing: As long as it is resolved effectively, it can lead to personal and professional growth. You will be dealing with ...
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Global Expansion Summit
Skip to main content. 2016 Sponsors and Exhibitors. 2016 Sponsors and Exhibitors. Earlybird tickets have just gone on sale. Register now! Sign up for our newsletter. Speakers announced for 2017 include:. Speaker applications are now open! Apply to speak at our 2017 event. About Global Expansion Summit. Global Expansion Summit is the leading global event on international expansion and doing business across borders in the era of innovation and technological transformation. View all sponsors and exhibitors.
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GXPSYS Inc. | Best Validation & Regulatory Compliance services | Project Management
FRIDAY, April 18, 2011 12:00. Welcome to GXPSYS Inc. GXPSYS provides validation and compliance consulting services and industry specific products to the Pharmaceutical and Biotech industries. We provide expansive guidance and expertise in areas including quality systems, computer and equipment validation, automated process systems, commissioning and qualification of new and existing facilities, manufacturing and lab equipment systems. Our goal is to remain the industry leader in providing excelle...
GXP Systems
Helping life science organizations build strong and effective teams. Providing expert Regulatory Compliance solutions.
GxP Systems | The Regulatory Compliance Experts
The Regulatory Compliance Experts. Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. November 4, 2015. In February 2015, the US FDA released a draft guidance on the repackaging of certain products by pharmacies and outsourcing facilities. The closing date for comment was set for 17.05.2015, but when the actual guidance is expected to be implemented is still to be confirmed. No more than 14 days beyond completion of the sterility test or 28 days from the time of repackag...
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