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Everyone breathes a sigh of relief when the FDA investigators depart. But if they left behind a Form 483 pointing out deficiencies and noncompliance’s, that’s when the work really starts. The good news is that a well-reasoned response can help a company sidestep a warning letter or worse. The bad news is that the agency gives you only 15 business days to pull it together.
Don’t you hate sitting down to write your company’s response to a 483? Wouldn’t you like to know what other companies wrote, especially for CAPAs?
Our speaker Regulatory expert has culled the best — and some of the worst — responses the FDA has received to 483s. This webinar will walk you through which responses were good and which were not, so you can make your answers the best they can be.
Our presenter will show you the FDA's exact CAPA observations in each 483 and put them side-by-side with the company’s response. You’ll see how firms handled particular issues, especially the tone and language they used.
If your company hasn’t received a 483 with CAPA observations, you can match your systems with those that have and ensure that all gaps are closed before your next inspection.
This webinar “Effective 483 Responses: Focus on CAPA Violations” will provide the following:
Remember, you have only 15 days to respond to 483. Most of that time will go toward bringing your CAPA program into compliance. Don't waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality. Learn from those who have been there.
Who Will Benefit:
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.
To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector.
Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.