Browsing Category Compliance Tips

Managers: Spend $14,000 on a Mock Audit, or $480,000 on a Warning Letter Clean Up?

March 24, 2013 It might seem obvious, but the role of senior company leadership in FDA compliance is to really participate in the company’s quality system design and oversight. You need to ensure continual improvement of all of your quality system operations. One of the reasons this is so true is that according to recent [...]

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Category : Compliance Tips &News

Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement

March 6, 2013 Our recent excellent FDA compliance speaker, Dennis Moore, President, AUK Technical Services, had some great data on the latest FDA compliance trends, including the most common areas where companies are getting 483s. If you’ve ever dealt with the agency, you know how difficult it can be to extract recent data from them [...]

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Category : Compliance Tips &News

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 Johnson & Johnson debacle is just [...]

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Category : Compliance Tips

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 thoroughly, and regularly train and prepare all personnel, [...]

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Category : Compliance Tips

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 clinical data management/integrity and regulatory compliance. Here we [...]

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Category : Compliance Tips

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 example, a good option would [...]

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Category : Compliance Tips

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 an industry that needs to be more [...]

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Category : Compliance Tips

Avoiding these problems in GLP labs can save you a warning letter

Excerpted from The Journal of GXP Compliance There are recurring themes of observations documented in warning letters that relate directly to laboratory and study management. They are: 1. QA fails to do its job One common finding involves the failure of the quality assurance unit (QAU) to fulfill the require-ments of the GLP regulation. The following [...]

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Category : Compliance Tips

Digital Pen Speeds Data Management, Helps FDA Compliance

Digital Pen Speeds Data Management, Helps FDA Compliance Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around Anoto digital pen technology. It helps [...]

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Category : Compliance Tips

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