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compliance-alliance – Helping government and industry work together for safe and effective drugs and medical devices

Helping government and industry work together for safe and effective drugs and medical devices. Talking to Decision Makers. FDA Medical Device Inspections: Required Reading. Wishing for a Compliant CAPA System. Corrections and Removals (CARS). Can Compliance be Taught? They write. They speak. They meet. Our training helps them communicate more effectively in each mode. Better Communicators are Better Employees. Communication Training Has to be Fun. We’ve been traveling to medical product companies to pre...

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compliance-alliance – Helping government and industry work together for safe and effective drugs and medical devices | compliance-alliance.com Reviews

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Helping government and industry work together for safe and effective drugs and medical devices. Talking to Decision Makers. FDA Medical Device Inspections: Required Reading. Wishing for a Compliant CAPA System. Corrections and Removals (CARS). Can Compliance be Taught? They write. They speak. They meet. Our training helps them communicate more effectively in each mode. Better Communicators are Better Employees. Communication Training Has to be Fun. We’ve been traveling to medical product companies to pre...

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compliance-alliance – Helping government and industry work together for safe and effective drugs and medical devices | compliance-alliance.com Reviews

https://compliance-alliance.com

Helping government and industry work together for safe and effective drugs and medical devices. Talking to Decision Makers. FDA Medical Device Inspections: Required Reading. Wishing for a Compliant CAPA System. Corrections and Removals (CARS). Can Compliance be Taught? They write. They speak. They meet. Our training helps them communicate more effectively in each mode. Better Communicators are Better Employees. Communication Training Has to be Fun. We’ve been traveling to medical product companies to pre...

INTERNAL PAGES

compliance-alliance.com

1

Free Documents and Websites

http://www.compliance-alliance.com/free-documents-and-websites

Free Documents and Websites. Compliance Program Guidance Manual. Points To Consider for the QSIT Design Controls Subsystem. Points to Consider for the QSIT Corrective and Preventive Actions (CAPA) Subsystem. Points to Consider for the QSIT Management Controls Subsystem. Medical Device Inspections: Required Reading. Wishing for A Compliant CAPA System. Guide to Inspections of Foreign Medical Device Manufacturers. Laws Enforced By the Food and Drug Administration. ORA Field Management Directive.

2

Mission

http://www.compliance-alliance.com/mission

We believe that pharmaceutical and medical technology companies create and market safe and effective products. We know that operating under government regulation is difficult, that product liability defense is expensive, and that adverse publicity can be crushing. We help companies change their culture to reduce the risks. Distinguished Service and Leadership Award from the Food and Drug Law Institute. Leadership Award in 2010 and 2014 from the Association of Food and Drug Officials.

3

Complaint Handling

http://www.compliance-alliance.com/free-documents-and-websites/complaint-handling

Helpful Information on Complaint Handling. Complaint Survey 2013 Results. Results of Complaint Handling Survey. In February of 2006, Compliance Alliance conducted a survey of how medical device firms are setting up their complaint handling systems. Two hundred and thirty six professionals filled out the survey. From the February 2006. On Getting a Handle on Complaints in MDDI Magazine. The preamble with information on 21. Get smart with the Thesis WordPress Theme.

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Articles

http://www.compliance-alliance.com/articles

Dangerous Documents: How Good Writing Can Help Medtech Firms Avoid. How can quality professionals get on management’s good side? Don’t Be Haunted By Your Words. (Advice to FDA and industry officials on how to write complete and accurate documents.). How to Not Get Sued. Mastering the Clinical Investigation. 8221; published in MD&DI Online. OEMs can benefit from the latest resources and current practices for clinical investigation programs. I wrote an article, “. 8221; that was published in RAJ Devices.

5

510(k) Survey

http://www.compliance-alliance.com/free-documents-and-websites/survey-results/510k-survey

Results of June 2008 Survey on 510(k) Submission Practices and FDA Clearances. And Certified Compliance Solutions. Ear nose and throat devices. General and plastic surgery devices. General hospital and personal use devices. Hematology and pathology devices. Obstetrical and gynecological devices. Get smart with the Thesis WordPress Theme.

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