Upcoming Webinars
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FSMA Landmines That Affect the International Food Supply Chain| June 11, 2013, 2 PM EDT | England
When companies start to think about the Food Safety Modernization Act (FSMA), they often focus on the big things - the Foreign Supplier Verification Program, HARPC, certification and so on. However, you should know that buried inside of FSMA are several serious landmines that many people are... Read More »
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Export Success – How to Successfully Export FDA and USDA Regulated Products to the US | June 6, 2013, 2 PM EDT | England
This unusual 60 minute webinar is designed for a wide range of companies in the drug, cosmetic, dietary supplement, food and medical device industries. This exciting Webinar will provide international viewers in particular with a broad understanding of the regulations, issues, requirements and... Read More »
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Update on Tanning Beds and the FDA 510(k) Submission Process, Contents and Format | June 12, 2013 | Lim
Exclusive cGMP, FDA and 510(k) Compliance News FDA in May 2013 came out with a proposed order that if it is finalized, is going to reclassify tanning beds and related sunlamp products as class II medical devices, and they will require a label that will warn people under 18 to not use such... Read More »
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How to Bulletproof Your 510(k) Submission: Best Practices for Preparation, Submission and Clearance | June 5, 2013, 2 PM EDT | Lim
Exclusive cGMP, FDA and 510(k) Compliance News This Webinar will tell you precisely how to prepare and submit a traditional premarket notification 510(k) for successful FDA clearance. The premarket notification 510(k) is the most common pathway to market for medical devices including in... Read More »
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The Essentials of Complaint Handling and Post Market Management – How to Comply with Global Regulatory Requirements | May 30. 2013, 2-3:30 PM EDT | Rodriguez
Complaint Handling and Post Market Management Webinar Summary FDA investigators consider how a medical device company handles complaints to be an important indicator of a manufacturer’s overall state of control of their Quality System— if the complaint and MDR systems are not in a "state of... Read More »
In the News Today
Recent Press Releases
Compliance Tips
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Readying for a US FDA Inspection
If your company produces drugs, medical devices or nutraceuticals that fall under US cGMP regulations, your facility is eventually going to be inspected by the U.S. Food and Drug Administration (FDA). The Federal Food, Drug and Cosmetic Act states that domestic drug establishments can be inspected... Read More »
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How To Create and Staff Your FDA Inspection War Room
Latest FDA and cGMP Compliance News To have a successful FDA inspection, your company really should create a war room in advance of the FDA visit. This is a strategic office that should be entirely devoted to giving all of the needed evidence that is requested by an FDA inspector... Read More »
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Exclusive Expertbriefings.com cGMP and FDA News
Below are the original Expertbriefings.com cGMP and FDA-related stories for 2013. Be sure to check out our upcoming events, too! FDA cGMP Compliance News and Tips May 23 - Readying for a US FDA Inspection May 22- FDA Inspectors Give 483s to 7 of 10 Dietary Supplement Companies May... Read More »
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Court Tells FDA That FSMA Deadlines Are Required
Latest FDA and cGMP Compliance News The Food Safety Modernization Act, or FSMA, has made major changes in how FDA and the government is monitoring food safety. FSMA has science based standards and controls on food companies, and it directs companies to do hazard analysis and to create... Read More »
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How To Improve Your CAPA System
Latest FDA and cGMP Compliance News FDA reports that more than 50% of the top FDA 483 citations and warning letter observations are always related to CAPA, or corrective and preventive actions. A strong CAPA system is set up to ID and correct faulty processes that cause a nonconformance, and... Read More »
