Jennifer Perrin

Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

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Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities. 

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The FDA's Center for Drug Evaluation and Research has released its latest report on the state of pharmaceutical quality. This report is a comprehensive overview that sheds light on the agency's efforts to ensure the safety, efficacy, and quality of drugs available to patients. In the report you can find topics including: -Trends in manufacturing quality and compliance. -Efforts to modernize manufacturing technologies. -Strategies to address challenges in global drug supply chains. Check out the full report below #PharmaceuticalQuality | #FDA | #DrugSafety | #RegulatoryCompliance #Healthcare | #CDER | #QualityAssurance | #IndustryInsights

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

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Did you miss our latest blog outlining the differences between the new ICH M12 Guidelines and the 2020 FDA DDI Guidance? Read all about it here: https://hubs.ly/Q02DSm4M0 You can always browse our comprehensive catalogue of publications on our Science Pool: https://hubs.ly/Q02DSwXF0 Find everything you need in the Science Pool, including our webinars, case studies, posters and publications from across Evotec, Cyprotex, and Just Evotec Biologics. #Cyprotex #Pharma #DrugDevelopment #ClinicalResearch #ICHM12

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👉 #LifeSciences Quality and Compliance Professionals: Do you ever wish it was easier to make the business case for investing in a Quality Culture? Don't miss what is sure to be an actionable discussion with former FDA Investigator and current CREO Director of Quality and Regulatory Services, Vincent F. Cafiso, on how to calculate the cost of quality in life sciences. Register here: https://hubs.la/Q02M7h380 #qualityassurance

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There's still time to register for our webinar: Core Requirements for a Successful Biopharma Sample Ordering System Join Matt Peel, Technical Product Manager at Titian to learn about essential considerations before setting up your sample requesting system: https://hubs.ly/Q02CpKlX0 #SampleManagement #Scaling #Biopharma #Webinar

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Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/4dmRzaS #pharmamfg #contractmfg

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FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

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FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

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FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

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When submitting your product for approval, understanding if your risk-benefit profile may require one or more REMS elements and working directly with the FDA is critical. Learn more in a presentation from REMS Project Operations Director Natalie Eiland at the REMS Innovation Summit: https://hubs.li/Q02FDWNp0 #PatientsFirst #REMS #REMSSummit #PatientSafety

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Haven't worked with us before? Learn how our facilities are designed with cGMP manufacturing and ICH regulatory compliance in mind: https://hubs.la/Q02w8Xyd0 #GMP #RegulatoryCompliance #CorealisPharma #CDMO #SolidScience

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Reminder: Our complimentary webinar "Innovating H.R. Hiring Practices: Virtual Drug Testing Strategies for a Modern Workforce" is tomorrow. Last chance to register: https://bit.ly/4ancclH #BackgroundScreening #DrugTesting #OralFluidTesting #Proctoring #HumanResources #RemoteWorkforce

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Drug testing of employees in highly regulated industries can be a challenge. Learn how Empeek helped Applicant Information gain a competitive advantage by cutting testing cycle time by 75% and increasing testing volume by 350%. https://buff.ly/3UQhJwn #LabTesting #EmployeeScreening #HealthTech #LabTech

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CAPA is a core part of ICH Q10, focusing on identifying and resolving quality issues to prevent recurrence. Learn how to implement effective CAPA processes and ensure continuous improvement in your pharmaceutical quality system ⤵️ https://bit.ly/4grDlHP #ichq10 #capa #pharma #quality #compliance #pqs

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FDA's CDER Quality Standards Program posted two additional consensus standards to support pharmaceutical quality. These updates are part of CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality aimed at advancing regulatory consistency and encouraging adoption of recognized quality standards across the pharmaceutical industry. Visit the page to explore the latest additions and see how they align with CDER’s mission of ensuring safe, effective, and high-quality medications are available to all Americans ➡️ https://lnkd.in/eTrGd75F

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