The United States Food and Drug Administration (FDA) ensures the safety and quality of medical and pharmaceutical products. In order to uphold the standards of products that the public has access to, the FDA inspects and authorizes products according to a set of stringent standards, conducts inspections of manufacturing facilities, and monitors product recalls to determine whether appropriate remediation measures have been taken. Overseas organizations providing medical and pharmaceutical products must be aware of the FDA's compliance requirements before introducing their product to the US market.

During the course of inspections, FDA investigators may encounter conditions that are not ideal or in compliance with specified regulatory standards. In such cases, a red flag is raised and the organization is sent a FDA-483 - a letter that details the problem found and describes the scenario or standards in question. The observations within the FDA-483 are concise and describe the issues clearly, which helps organizations initiate quick response measures. Some of the issues that the FDA-483 tackles are current Quality System (cGMP) problem areas for manufacturers, including pre-market approval, adulteration of drugs, and radiation control. It also ensures that customer complaints are properly addressed.

Join this webinar with Lori A. Carr, a Medical Device Regulatory and Quality Consultant for the FDA with over 19 years of experience in this field, and Timothy Schmutzler, Regional Vice President of GRC Solutions at MetricStream. During this webinar the speakers will explain how your organization can prevent an FDA warning letter and ensure compliance with current FDA guidelines. Some of the topics to be discussed in this webinar include:

  • FDA foreign and domestic manufacturer inspections and enforcement methods
  • Current FDA-483 inspectional observations and preventions
  • Top citations for medical device and pharmaceutical manufacturers
  • 8 areas of focus which can help ensure FDA compliant quality systems and manufacturing practices
  • The role of technology in preventing warning letters


Attend the webinar
The webinar is scheduled to take place on Tuesday, May 14, 2013 at 10:00 am Eastern Time. To register for this webinar, and to learn more about the webinar and speakers, please click here.

About MetricStream

MetricStream, the independent market leader in enterprise and cloud applications for Governance, Risk, Compliance (GRC) and Quality Management, makes GRC simple. MetricStream apps improve business performance by strengthening risk management, corporate governance, regulatory compliance, vendor governance, and quality management for hundreds of thousands of users in dozens of industries, including Financial Services, Healthcare, Life Sciences, Energy and Utilities, Food, Retail, CPG, Government, Hi-Tech and Manufacturing. MetricStream is headquartered in Palo Alto, California, with an operations and R&D center in Bangalore, India, and sales and operations support in 12 other cities globally. (www.metricstream.com).

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Molly Palm : pr@metricstream.com | (925) 451-1468

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