Limitations of 5 Whys in CAPA and Root Cause Analysis
More Exclusive FDA cGMP Compliance News April 15, 2013 FDA’s Quality System Regulation, and also the Quality Systems Approach to cGMP Regulations require CAPA (21 CFR 820.100) with root cause analysis as a reactive tool for quality system improvement to make sure such problems do not recur. Many in the pharmaceutical industry know the […]
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Stability Testing a Common Problem in FDA Warning Letters
More FDA, cGMP Compliance News Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 15, 2013 Stability testing of drug products is required by 21 CFR 211.166Â of the cGMP guidelines. Stability is how much the product remains in established parameters at the established conditions and needed shelf life. Problems […]
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21 CFR 211.194 – Tips for Laboratory Records Compliance for QC Laboratories
More FDA, cGMP Compliance News Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 15, 2013 There are major implications for the pharmaceutical laboratory regarding FDA’s requirements for risk assessment and management all through the product life cycle. The onus is now on the pharmaceutical industry. You need to address […]
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21 CFR 820.198 – Implementing Risk-Based Management in Handling Complaints
More Exclusive FDA cGMP Compliance News Complaint Handling – 21 CFR 820.198 A strong complaint-handling process, according to 21 CFR 820.198, is a system of management that guarantees the highest possible level of patient safety. It also secures the highest possible investment return and it reduces product liability lawsuits to the minimum. A good complaint-handling system […]
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FDA Social Media Guidance Coming!
More Exclusive cGMP FDA Compliance News For the past few years, drugmakers have grappled with the Internet and how to promote their medicines to an increasingly interactive public. Although the FDA held a widely attended meeting in 2009 and indicated that a draft guidance would soon be forthcoming, the agency has yet to do issue […]
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21 CFR 820.198 – Avoiding Pitfalls in Your Complaint-Handling Process
More Exclusive FDA cGMP Compliance News Complaint Handling 21 CFR 820 A complaint is defined in 21 CFR 820 and the Safe Medical Devices Act as an report of dissatisfaction with device quality or performance, or a defect after a product was sent into distribution. A complaint, therefore, is a great post market surveillance tool. […]
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Setting Up Your Bulletproof MDR File, and How to Avoid Landmines
More Exclusive cGMP FDA Compliance News May 2- Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 11, 2013 May 2- Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission As we noted in our earlier article, medical device firms usually have to report an MDR […]
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Understanding the Medical Device Reporting Regulations
More Exclusive cGMP FDA Compliance News May 2- Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 11, 2013 Back in 2003, Endovascular Technologies, which made medical devices to treat some types of aortic aneurysms, pled guilty in federal district court to a shocking 10 felonies. The firm agreed to […]
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Essential cGMP Quality Tips for Senior Managers
More Exclusive FDA and cGMP Compliance News According to a former FDA deputy chief counsel, senior managers and executives need to know and prevent non-compliance of cGMP regulations. As a senior manager for an FDA-regulated drug or device company, you are responsible for cGMP guidelines being followed in your company’s quality systems. You need to […]
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Expert Recommendations for FDA eCopy Submission
April 10, 2013 Our April 10 Webinar on Avoiding the eCopy Confusion by Antoinette Azevedo had some vital expert recommendations. For instance Print to PDF is NOT an option with preparing PDFs for eSubmitter! This webinar really helped to shed some light on this very confusing and misunderstood guidance that became a requirement on Jan. […]
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