Trinity Consultants - Aztec Technologies, Inc.

Who's attending ISPE’s Boston Products Show this year? The team from Trinity Consultants will be there! Join us at Booth E157, where our Life Sciences team, including experts like Ivan Mak, P Eng, Roop Kumar, and Kenny Tran, are ready to engage with you. Explore our wide-ranging services and innovative solutions tailored for the #pharma and #biopharma sectors. Dive into discussions on #ProcessEngineering, #CQV, #Automation, and #DigitalTransformation that can propel your projects forward. Click here to learn more: https://lnkd.in/dsN2Qc7? Trinity Consultants - Advent Engineering Trinity Consultants - Aztec Technologies, Inc. #LifeSciences #Innovation #ISPEBoston #TrinityConsultants

Have you struggled to interpret FDA's requirements for testing and assessments for Extractables & Leachables? Don't worry, we've got you covered! We're excited to announce Trinity's upcoming LinkedIn Live event on September 12. We'll dive deep into challenges and tips for obtaining, interpreting, and submitting E&L data. Join our experts, Allan Ader, George (Mac) Taylor D.V.M., D.A.B.T, Michael Ruberto, and Michele Lobo as they lead a Q&A session covering burning questions. This is your opportunity to learn more about the ins & outs of E&L. ? Of course, we can start the conversation now! Share your most pressing questions related to E&L and submissions in the comments below. Your question might just be one we answer live during the event! #LifeSciences #Extractables #Leachables

Navigate the "Wild West" of Extractables & Leachables ?? Extractable and leachables studies are an increasingly crucial part of FDA submissions that require complex testing and assessment without clear or comprehensive regulation. It's like the "Wild West," – and it can derail regulatory approvals for new drugs. To avoid these delays and keep your projects on track, you need a deep understanding of E&L requirements and how to interpret analytical data and conduct risk assessments. That's where our E&L Boot Camp comes in! Join us for a comprehensive 1.5-day course led by industry experts: · ? Allan Ader, Ph.D., DABT: 30+ years in pharmaceutical toxicology · ? Michael Ruberto, Ph.D.: 25+ years in pharma and biotech E&L studies · ? George (Mac) Taylor D.V.M., D.A.B.T: Expert in exposure and toxicological assessments We'll cover everything from the overview of US regulations to the impact of leachables risk factors and how to develop appropriate testing programs. Watch our video for more information! Register now to secure your spot and advance your knowledge of the key concepts involved in E&L. https://lnkd.in/gqDuMdTy #Pharmaceuticals #ExtractablesAndLeachables #RegulatoryCompliance #HealthandSafety #FDA #RiskAssessment