Are you ready for eCTD 4.0? Don't get left behind! Join our webinar to explore the new submission structure of eCTD 4.0 and discover how the right software can make the transition to eCTD v4.0 easy. Register now: https://lnkd.in/eZcgPcjK #eCTD #cloud #software #technology #regulatory #submissions #lifescience #regulatoryaffairs #regops #regulatorytechnology #regulatorycompliance #pharmaceutical #efficient #EMA #FDA
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Are you ready for eCTD 4.0? Don't get left behind! Join our webinar to explore the new submission structure of eCTD 4.0 and discover how the right software can make the transition to eCTD v4.0 easy. Register now: https://lnkd.in/eZcgPcjK #eCTD #cloud #software #technology #regulatory #submissions #lifescience #regulatoryaffairs #regops #regulatorytechnology #regulatorycompliance #pharmaceutical #efficient #EMA #FDA
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Why is it important for pharma and biopharma to increasingly digitalize their laboratories? 🔬 Join our live webinar, where our experts Peter Baker (former U.S. FDA drug inspector) and Bob McDowall (pharma automation and data integrity expert) will discuss this topic from both a regulatory and business benefit point of view. https://bit.ly/3Bdt5De #LabDigitalization #LabAutomation #LabTech #DigitalLab #SmartLabs #DataQuality #Pharma #PharmIndustry #PharmaAutomation #BiotechAutomation #PharmaTech
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#MettlerToledoWebinar | Join our live webinar, where our experts Peter Baker (former U.S. FDA drug inspector) and Bob McDowall (pharma automation and data integrity expert) will discuss this topic from both a regulatory and business benefit point of view.
Why is it important for pharma and biopharma to increasingly digitalize their laboratories? 🔬 Join our live webinar, where our experts Peter Baker (former U.S. FDA drug inspector) and Bob McDowall (pharma automation and data integrity expert) will discuss this topic from both a regulatory and business benefit point of view. https://bit.ly/3Bdt5De #LabDigitalization #LabAutomation #LabTech #DigitalLab #SmartLabs #DataQuality #Pharma #PharmIndustry #PharmaAutomation #BiotechAutomation #PharmaTech
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Hope you can join us as we discuss the #digital transformation within the ever changing and challenging world of #GXP! Side Note: preparing to debate Bob McDowall (an expert on all things laboratory) on a live webinar has been my most challenging task of 2024 🤣🤣
Why is it important for pharma and biopharma to increasingly digitalize their laboratories? 🔬 Join our live webinar, where our experts Peter Baker (former U.S. FDA drug inspector) and Bob McDowall (pharma automation and data integrity expert) will discuss this topic from both a regulatory and business benefit point of view. https://bit.ly/3Bdt5De #LabDigitalization #LabAutomation #LabTech #DigitalLab #SmartLabs #DataQuality #Pharma #PharmIndustry #PharmaAutomation #BiotechAutomation #PharmaTech
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Strategy developer I strategic marketing and communications I sales management and relationship building I innovation and design thinking.
Our upcoming webinar will discuss the significant business and regulatory benefits that pharma / biopharma labs can gain from increased digitalization
Why is it important for pharma and biopharma to increasingly digitalize their laboratories? 🔬 Join our live webinar, where our experts Peter Baker (former U.S. FDA drug inspector) and Bob McDowall (pharma automation and data integrity expert) will discuss this topic from both a regulatory and business benefit point of view. https://bit.ly/3Bdt5De #LabDigitalization #LabAutomation #LabTech #DigitalLab #SmartLabs #DataQuality #Pharma #PharmIndustry #PharmaAutomation #BiotechAutomation #PharmaTech
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Great experience at Mettler-Toledo International, Inc's webinar on digitalization in laboratories. The positive impact of digitizing production processes and data collection, such as quality control sampling, would be seen in reduced time and increased agility for validation. Now, let’s think about how to put it into practice!
Why is it important for pharma and biopharma to increasingly digitalize their laboratories? 🔬 Join our live webinar, where our experts Peter Baker (former U.S. FDA drug inspector) and Bob McDowall (pharma automation and data integrity expert) will discuss this topic from both a regulatory and business benefit point of view. https://bit.ly/3Bdt5De #LabDigitalization #LabAutomation #LabTech #DigitalLab #SmartLabs #DataQuality #Pharma #PharmIndustry #PharmaAutomation #BiotechAutomation #PharmaTech
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#Statistics for the #pharmaceutical industry? Then you need a statistical software that is seriously compliant with FDA guidelines. No worries, we have that software! It's TIBCO Statistica. Take a look here on StatSoft GmbH website: https://lnkd.in/dvrVhrzN #alternativeToMinitab #qualityByDesign #stabilityStudy #pqr #qualityAssurance
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𝗙𝗗𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲: 𝗥𝗲𝗴𝗶𝗼𝗻𝗮𝗹 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗚𝘂𝗶𝗱𝗲 𝗳𝗼𝗿 𝗘𝟮𝗕 (𝗥𝟯) 𝗲-𝗧𝗿𝗮𝗻𝘀𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗼𝗳 𝗜𝗖𝗦𝗥 𝗮𝗻𝗱 𝗣𝗿𝗼𝘃𝗶𝗱𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 𝗶𝗻 𝗘𝗹𝗲𝗰𝘁𝗿𝗼𝗻𝗶𝗰 𝗙𝗼𝗿𝗺𝗮𝘁: 𝗜𝗡𝗗 𝗦𝗮𝗳𝗲𝘁𝘆 𝗥𝗲𝗽𝗼𝗿𝘁𝘀 Guidance: https://lnkd.in/eKPngD7b This FDA guide explains how to electronically submit reports on side effects of various medications to the FDA. It covers a broad range of drugs, including prescription and over-the-counter medications, as well as biological products. Beyond specifying what to report, the guide focuses on the technical aspects of electronic submissions, ensuring consistent formatting and data collection that meets the FDA's specific requirements. This streamlined process allows healthcare providers, researchers, and even patients to contribute to the FDA's database on medication safety. Contact BIOBOSTON CONSULTING today or visit our website to learn more about how we can support your organization. #pharmaceuticals #biotechnology #medicaldevices #consulting #fda #quality #compliance #qualityassurance #regulatoryaffairs
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📣 ICYMI: Our May blog post is up on the website. This month, we share why you should use publicly available data to prepare for an FDA Inspection. 🔍 The data is out there, let's use it and learn from it. https://wix.to/PadqUjC #newblogpost #qualitysystems #quality #meddevice #pharma
Three Reasons to Utilize Industry Data for FDA Inspection Preparedness
qualitysystemsservices.com
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You can’t meet regulatory requirements in the pharmaceutical and healthcare industries without data integrity. Regulatory agencies set strict guidelines to ensure products meet the necessary standards for efficacy and safety. To meet compliance standards, data integrity requires: * Accurate Data Collection * Secure Data Storage * Audit Trails * Transparent Reporting Are you missing the target on data integrity? Find out here. https://cc94.co/3T6rYf6 #lifesciences #compliance #dataintegrity
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