…down time, and as a result, this article will be brief. Especially when compared to previous articles of DG, which exhibit the doctor’s propensity toward being longwinded. Warning letter violation…
…down time, and as a result, this article will be brief. Especially when compared to previous articles of DG, which exhibit the doctor’s propensity toward being longwinded. Warning letter violation…
…and Clinical Utility of Laboratory-developed Molecular Tests”: http://www.cms.gov/determinationprocess/downloads/id72TA.pdf July 2007 FDA Draft Guidance on IVDMIAs: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079148.htm September 2007 FDA Guidance: FAQs on Analyte Specific Reagents (ASRs): http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm078423.htm April 2008 Final…
…and Clinical Utility of Laboratory-developed Molecular Tests”: http://www.cms.gov/determinationprocess/downloads/id72TA.pdf July 2007 FDA Draft Guidance on IVDMIAs: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079148.htm September 2007 FDA Guidance: FAQs on Analyte Specific Reagents (ASRs): http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm078423.htm April 2008 Final…
…activities to include the results, as required by 21 CFR 820.80(e)(3). For example: a. Packaging Specification Sheets for a Foil Pouch (POU-055 – D03-ES123 – Revision 03) and the Raw…
…activities to include the results, as required by 21 CFR 820.80(e)(3). For example: a. Packaging Specification Sheets for a Foil Pouch (POU-055 – D03-ES123 – Revision 03) and the Raw…
…Drug Administration Website. (2010). Warning letters. Retrieved July 23, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ GHTF/SG3/N99-10:2004. (2004, January). Quality management systems-process validation guidance. Global Harmonization Task Force. Retrieved July 26, from http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf …
…Drug Administration Website. (2010). Warning letters. Retrieved July 23, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ GHTF/SG3/N99-10:2004. (2004, January). Quality management systems-process validation guidance. Global Harmonization Task Force. Retrieved July 26, from http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf …
…company’s handling of complaints a good indicator of its understanding of and ability to implement the Quality System Regulation in an appropriate manner, but the procedures and reasoning behind complaint…
…company’s handling of complaints a good indicator of its understanding of and ability to implement the Quality System Regulation in an appropriate manner, but the procedures and reasoning behind complaint…
In this week’s edition of Devine Guidance (DG), the doctor continues with his prolegomenon (look-it-up if you need to) examination of the Quality System Regulations (QSR) while continuing to provide…
In this week’s edition of Devine Guidance (DG), the doctor continues with his prolegomenon (look-it-up if you need to) examination of the Quality System Regulations (QSR) while continuing to provide…
…Cognizant Technology Solutions. (2001). CFR Part 11 Compliance – The Cognizant Approach. Retrieved July 13, 2010, from http://www.21cfrpart11.com/files/library/compliance/cfr_whitepaper.pdf Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical…
…Cognizant Technology Solutions. (2001). CFR Part 11 Compliance – The Cognizant Approach. Retrieved July 13, 2010, from http://www.21cfrpart11.com/files/library/compliance/cfr_whitepaper.pdf Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical…
…when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, when requested no validation documentation…
…when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, when requested no validation documentation…
…2010, from http://www.microbiologyforum.Org/PMFNews/PMFNews.14.08.0808.pdf Tierney, P., Burke, R., O’Donnell, B., & McAteer, J. (2010, May). Environmental monitoring – maintaining a clean room. Pharm Pro Magazine. Retrieved July 5, 2010, from http://www.pharmpro.com/articles/2010/06/clean-rooms-Environmental-Monitoring-Maintaining-a-Clean-Room/…
…2010, from http://www.microbiologyforum.Org/PMFNews/PMFNews.14.08.0808.pdf Tierney, P., Burke, R., O’Donnell, B., & McAteer, J. (2010, May). Environmental monitoring – maintaining a clean room. Pharm Pro Magazine. Retrieved July 5, 2010, from http://www.pharmpro.com/articles/2010/06/clean-rooms-Environmental-Monitoring-Maintaining-a-Clean-Room/…
…ISTA-2A Overview. Retrieved June 24, 2010, from http://www.ista-1a-2a-3a.com/index.html Prop 65 News. (2010, June). Your online guide to California’s unique environmental statute, proposition 65. Retrieved June 21, 2010, from http:// www.prop65news.com/pubs/brochure/madesimple.html…
…ISTA-2A Overview. Retrieved June 24, 2010, from http://www.ista-1a-2a-3a.com/index.html Prop 65 News. (2010, June). Your online guide to California’s unique environmental statute, proposition 65. Retrieved June 21, 2010, from http:// www.prop65news.com/pubs/brochure/madesimple.html…
