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keywords: description:SME Webinar, FDA 483, fda briefing, fda expert, fda, webinar Upcoming EventsArchived RecordingsAbout UsContact Us Impact of FDASIA - New Quality Agreements Guideline, and Compliance Program Guide Sec. 490.100 for Process Validation
Live Webinar - Jan. 8, 2014
Presentation by Carmen Medina, President, Precision Consultants
Free CD and recording download included!
Damage Control! How to Handle an FDA Drug or Device Recall June 12, 2 PM EDT Moore
GotoWebinar: Verification and Validation Planning and Execution July 24, 1 PM EDT Lincoln
GotoWebinar: Bullet-Proof Closed-Loop CAPA, Failure Investigation, and Root Cause Analysis June 5 Lincoln
GotoWebinar: CGMPs DHF, DMR, DHR, and EUs Technical Documentation June 11, 2019, 1 PM EDT Lincoln
-CLICK HERE TO SEE A FULL LIST OF OUR UPCOMING EVENTS- In the News Today How Pharmaceutical Packaging Can Lead to Product Recalls
Canada Has Completed Its Transition to MDSAP
FDA Audit Shows Data Manipulation at Immunonedics Plant
Why Do You Need a Quality Agreement?
Recent Press Releases
Autism Not Caused by Vaccines: Study
Alexion Hammered in FDA Inspection
Impax Shares Plummet as FDA Finds Manufacturing Issues
FDA flags new concerns on Hospiras Rocky Mount plant
Pharma Manufacturing Quality Management China 2012 is Upcoming
Compliance Tips Top 10 Reasons Deviation Investigation Systems Fail
For many drug companies, we find that manufacturing is a bit of a crapshoot. There is not a great deal of basis for confidence that the proper equipment, components, materials, people and records are going to be in the proper place to start manufacturing. And once that manufacturing... Read More
FDA cGMP Compliance News and Tips by Expertbriefings.comBelow are the original Expertbriefings.com cGMP and FDA-related stories for 2014. Be sure to review our new FDA Digest e-newsletter - learn FDA news and compliance tips, and also read our exclusive 483 and warning letter reports.FDA cGMP Compliance News and Tips March 4 - Will OTC Lipitor... Read More
Ingredient Supplier Audits Free of Bias?If you work for a pharmaceutical firm, let's say that you are responsible for ensuring that your company's excipient suppliers have the proper cGMP quality controls in operation. In past years, you might have relied on the responses that suppliers sent to a questionnaire, but FDA is raising the bar... Read More
5 Critical Tips to Solve An FDA Warning Letter CrisisEvery year, FDA sends out hundreds of warning letters to drug and device companies for cGMP and quality system regulation violations. Some of the violations are for manufacturing violations and some are due to misbranding and mislabeling. Firms that respond effectively to an FDA warning letter are... Read More
Reminders About FDA Requirements for Qualifying VendorsFDA Compliance NewsFrom the point of view of FDA, it is not required for a drug company to do a site audit of a supplier or vendor. According to 21 CFR 211.84, all of the lots of all components have to be tested before they can be used for compliance purposes with predetermined... Read More
ExpertBriefings.com, for the third year running, has been awarded Best Content winner in the FDA-Related Online Education/Webinars category. Navigate by Category Archived Recordings Compliance Tips News Press Releases Terminology Upcoming Events Valuable Content from EBAbbreviationsTerminologyNewsPress ReleasesUpcoming Events21 CFR Part 11Clinical ResearchCompliance TipsComputer ValidationFDA EnforcementFDA 483sWarning LettersRecent Briefings Many of our recently held briefings are available as downloadable files. Contact Us to access our Audio Library for our highly regarded series on:
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