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Publications by quality professionals to help FDA regulated businesses and ISO 9000
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GMP Training Newsletter Using Stories, Anecdotes, and Metaphors to Make your GMP Training Come Alive - By David C. Markovitz

"A Picture is Worth a Thousand Words"

As a consultant and trainer with over three decades experience in the FDA regulated industries, I know that this proverb is true. I have helped numerous companies improve their communications with their employees by helping them express ideas and concepts through stories and word pictures.

  Spring 2011 Newsletter
Risk Management Strategy for Medical Devices Developing a Risk Management Strategy for Medical Devices in the US Market

Risk management is an essential component of regulatory compliance for medical device companies marketing their products within the US. Yet, since risk management requirements have evolved over the course of more than a decade, it is not possible for a regulatory professional to rely upon just one source to determine exactly what type of risk management system should be implemented to comply with US regulations.    Spring 2010 Newsletter
Process Validation Prerequisites Summer 2008 Newsletter
Process Validation Prerequisites 101

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the accumulation of documented evidence that demonstrates with a high degree of assurance that a process can consistently meet its predetermined specifications and quality attributes.   Download Newsletter
Revised EU Directives Spring 2008 Newsletter
Revised EU Directives

Since the European single market activities of the late 1980s, three main medical device directives have passed into law in the countries that make up the European Union (EU). These New Approach directives regulate how devices may be placed on the market and identify postmarketing vigilance requirements.
  Download Newsletter
How to Manage an FDA Inspection Fall 2007 Newsletter
How to Manage an FDA Inspection

For everyone involved, FDA inspections are time-consuming and labor-intensive processes, but they needn?t be frustrating or mysterious if a company has prepared properly. The most important preparation is complying with the pertinent laws and regulations, including developing safe and effective products and implementing an effective quality system.

  Download Newsletter
Auditing a Device Company Summer 2007 Newsletter
Auditing a Device Company-It's just paperwork?

When FDA inspects a device facility, it is natural for the staff to be concerned and more than apprehensive. This is to be expected when the outcome can result in loss of stock value, income or personal advancement. However, when an auditor arrives, the reaction is the same.

  Download Newsletter
                         
  
GMP Labeling periodically publishes articles by quality professionals that we feel are useful and informative.

We hope that you find these articles helpful as a part of your continuing professional education.   

  
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