Upcoming Webinars
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Top Compliance Trends for 483 and Warning Letters for 2012 – Based on Rare FDA Data | March, 8, 2012, 2-3:30 PM EST | Moore
FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant. Now, in our unique 90-minute webinar, you can learn the detailed trends of 483 and warning letter for... Read More »
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Audit Your Lab Like an FDA Auditor: A Roadmap to Lab Compliance – From cGMPs to Inspection Readiness| Feb. 1, 12-1:30 PM EDT| Medina
This one-of a kind, comprehensive workshop will guide participants through understanding the substantive requirements for any lab, domestic or foreign, interested in validating, testing, and releasing drug product in support of regulatory submissions, as clinical trial material, or for... Read More »
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Avoid Your Career Being Ruined by Product Recall – Update From FDA Recall Chief – Jan. 24, 2012
This can easily happen to you if your company undergoes a product recall. Or this: Did you know that your career can be ruined, or you can even do jail time, in a product recall? It has happened. Read here. And here. All FDA and DOJ have to show is that you 'should have known' about... Read More »
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Prepare for an FDA Pre-Approval Inspection – FDA Investigator Perspective| Jan. 17, 2-3 PM EDT | Bennett
New Date - Jan. 17, 2012, 2-3 PM EST - Free Recording Included This detailed Webinar by a former FDA investigator will teach participants about the development of FDA pre-approval inspection program, its purpose and scope, how they are conducted, and suggest practical steps to ensure... Read More »
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How to Manage Supplier Risk – Archived Presentation by John Avellanet
John Avellanet of Cerulean Associates LLC, presents a risk-based, cost-conscious approach to supplier selection, oversight and management. John is an an internationally acknowledged expert, speaker and syndicated author on lean regulatory compliance, preventing intellectual property theft and... Read More »
In the News Today
Recent Press Releases
Compliance Tips
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FDA Calls for Corporate Commitment and Leadership at PolyCarbon Industries
Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership. We have reported before that the FDA expects corporate oversight of the Quality Management System. The... Read More »
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Compliance Tips For cGMP Inspections
Successfully managing a cGMP inspection begins first with developing a clear cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection. Because the FDA can arrive at your company without any prior notification, it is important that you... Read More »
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FDA Inspection Wizard – What’s Scary Can Turn Out to Be a Piece of Cake
Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is basically a quality assurance process that is used to confirm... Read More »
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How to Perform a Mock Audit
After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit. You can base your selection on the criteria established by the FDA and on the type of work your company does; for... Read More »
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What You Need to Know About Vendor Audits
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in... Read More »


