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QMS Consulting, Medical Device Consulting, CAPA, Medical Devices

Expert QMS consulting for medical device companies and their supply chain.

http://www.qmsconsultant.com/

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QMS Consulting, Medical Device Consulting, CAPA, Medical Devices | qmsconsultant.com Reviews
<META>
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Expert QMS consulting for medical device companies and their supply chain.
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1 FDA warning letter
2 GMP
3 In house Training
4 Education
5 Supplier Quality
6 Compliance
7 483
8 Risk management
9 QSIT
10 medical device compliance
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sue jacobs,downloads & events,capa,links,email*,fda enforcement action,certification audits,remediation,auditing,internal quality auditing,due diligence,supplier audits,fda readiness,complaint management,mdr reporting,process development,training
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QMS Consulting, Medical Device Consulting, CAPA, Medical Devices | qmsconsultant.com Reviews

https://qmsconsultant.com

Expert QMS consulting for medical device companies and their supply chain.

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1

Sue Jacobs, Susan B. Jacobs, Susan Jacobs

http://www.qmsconsultant.com/id2.html

QMS Consulting, Inc. Founder and President of QMS Consulting, Inc.,. GMP expert witness on behalf of the US Food and Drug Administration. ASQ Board of Directors as National Director (2004-06). Contributing author The Biomedical Quality Auditor Handbook, Published 2003. Chairman of the ASQ Biomedical Division (2002-2004), Program Chair 1997 - 2001 (RAPS). GMP Requirements and Industry Practice Course Instructor - AAMI (Association for the Advancement of Medical Instrumentation). Click here to download CV.

2

CAPA, Corrective Action, Preventive Action

http://www.qmsconsultant.com/id4.html

QMS Consulting, Inc. CAPA (Corrective Action and Preventive Action) continues to be an area of emphasis during FDA Inspections and Notified Body audits. An effective CAPA system will enable your company to achieve its compliance and regulatory obligations and improve your ability to meet business goals. State the problem in measurable terms (how often, how much, where and when). Emphasize the effects (risk) of the problem.

3

FDA Links, Quality Links, GHTF, Warning Letter

http://www.qmsconsultant.com/id5.html

QMS Consulting, Inc. Links to infomation that may be helpful to you and your business. American Society for Quality (ASQ) Biomedical Division. GHTF Latest Guidance Documents. CDRH Learn Course List. QSR Preamble Fed. Reg. No. 90N-0172. FDA Inspection Reference, Guides and Field Activities. FY 2008 FDA Enforcement Story. FDAWebview (some free links). Laws Enforced by the FDA and Related Statutes.

4

Downloads, Free Documents, Preamble, Points to Consider

http://www.qmsconsultant.com/id3.html

QMS Consulting, Inc. PREAMBLE - Quality System Regulation for Medical Devices. AdvaMed Points to Consider - Management Controls. AdvaMed Points to Consider - Design Controls.

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