…is a compliance disaster. Regardless, the behavior exhibited by these manufacturers is the failure to comply with DG Rule # 6 – All procedures, work instructions, drawings, specifications, etc. must…
…is a compliance disaster. Regardless, the behavior exhibited by these manufacturers is the failure to comply with DG Rule # 6 – All procedures, work instructions, drawings, specifications, etc. must…
…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of Laboratory-developed Molecular Tests”: http://www.cms.gov/determinationprocess/downloads/id72TA.pdf July 2007 FDA Draft Guidance on IVDMIAs: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079148.htm September 2007 FDA Guidance: FAQs on Analyte Specific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of Laboratory-developed Molecular Tests”: http://www.cms.gov/determinationprocess/downloads/id72TA.pdf July 2007 FDA Draft Guidance on IVDMIAs: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079148.htm September 2007 FDA Guidance: FAQs on Analyte Specific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…
…award warning letters for bad, or should I say, non-compliant behavior. In general, FDA frequently cites violators of section 820.80. The recipients of this week’s warning-letter extractions have violated two…
…award warning letters for bad, or should I say, non-compliant behavior. In general, FDA frequently cites violators of section 820.80. The recipients of this week’s warning-letter extractions have violated two…
This week, the doctor completes his guidance for 21 CFR, Part 820 – Subpart G (Production and Process Controls) with a review of, and guidance for, compliance with section 820.75,…
This week, the doctor completes his guidance for 21 CFR, Part 820 – Subpart G (Production and Process Controls) with a review of, and guidance for, compliance with section 820.75,…
…practices. Medical device manufacturers should refrain from employing metrology facilities and other outside testing laboratories that are not EN ISO 17025 compliant. Employing metrology labs that are certified to EN…
…practices. Medical device manufacturers should refrain from employing metrology facilities and other outside testing laboratories that are not EN ISO 17025 compliant. Employing metrology labs that are certified to EN…
…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…
…to support the commercial off-the-shelf program (b)(4) used to capture complaints, returned merchandise and service requests was provided. Quality System Regulation – 21 CFR, Part 820 QSR – Subpart G…
…to support the commercial off-the-shelf program (b)(4) used to capture complaints, returned merchandise and service requests was provided. Quality System Regulation – 21 CFR, Part 820 QSR – Subpart G…
…claiming compliance, while the agency rips apart your weakly compliant or non-compliant approach to production and process controls during one of their friendly visits. Warning Letter Violation Once again, identifying…
…claiming compliance, while the agency rips apart your weakly compliant or non-compliant approach to production and process controls during one of their friendly visits. Warning Letter Violation Once again, identifying…
…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…
