Regulatory Affairs Jobs in Life Sciences’ Post

🔬 Join the Process Validation for Biotechnological Products Masterclass - US Edition! Expand your knowledge and take your career to the next level with this exclusive online training opportunity. 📅 Mark your calendars for May 6-9, 2024, and get ready to learn from industry experts Mylene Talabardon & Hervé Broly. 🎓 Take advantage of our buy 1 get 1 free offer and secure your spot now! But hurry, as this promotion is only valid for limited registrations. 🔍 Gain a deep understanding of the requirements for process validations of medical devices, regulatory overviews of international requirements, and an understanding of the special characteristics of such process validations. 💼 This masterclass is ideal for process development scientists and managers, pharmaceutical development scientists and managers, manufacturing managers, QC and stability control managers, heads of quality assurance, and drug regulatory affairs managers. Don't miss this opportunity to upskill and stay ahead in the industry. Hurry, spaces are filling up fast! Register now and visit https://lnkd.in/gQX-xqKG for more information. ✉️ For direct contact, email [email protected]. #processvalidation #biotech #masterclass #pharmaceutical #biomanufacturing #regulatory #FDA #EMA #qualitycontrol #validation #verification #cGMP #bioprocess #drugdevelopment #biologics #clinicaltrials #goodmanufacturingpractice #pharmaceuticalindustry #biotechnologyindustry

📣 Interview questions and answer for Pharma regulatory affairs #regulatoryaffairs #regulatory #pharma #bpharmacy #mpharma #lifesciences #interviewpreparation #interviewtips #interview #regulatorycompliance Follow & join PG diplomas with RegGrow Academy (pharma, lifescience, biotech & medical devices)

Pharma Machines & Technology: Feb’24- March24’ Explore the Latest in Pharma: From Validation Models to Real-Time Tracking and Education Challenges! Stay ahead with our newest magazine issue, packed with insights on emerging digital technologies and the evolving landscape of pharmacy education supporting India's healthcare system. To read more, the link is the first comment box #pharmaceutical #cgmp #facilitydesign, #pharmaindustry #manufacturers #pharmaceuticalindustry, #qualityassurance #qualitycontrol #qualityculture #quality #regulatory #manufacturing #ceomindset, #ceoinsights #audits, #auditor, #compliancesolutions, #calibrationservices, #sops #procedures #cleaningservices #analytical #validation #laboratory #21cfrpart11 #dataintegrity #documentation #gdprcompliance #traininganddevelopment #collegesanduniversities #pharmacycollege #mpharm #bpharm, #pharmacy #mpharm #pharmaceutical #lifescience #chemical #pharma #technology

The lifecycle of pharmaceutical products inevitably leads to additional testing requirements due to validation requirement goalposts moving, regulatory changes to the specification and limits of certain related substances and impurities, as well as the result of the need to adopt less environmentally impacting methods and techniques.  Butterworth Laboratories has 50 years of experience in developing and validating test methods and can provide you with the necessary support to help ease the burden at any stage of your product lifecycle. We have a wide array of up-to-date instrumentation to enable us to undertake all your analytical chemical testing and the capacity to meet your deadlines. Dedicated project managers and project analysts are at your disposal to ensure you get a timely resolution which is tailor-made to your requirements. To find out more about Butterworth Laboratories and how we can help you with your outsourcing lifecycle needs, please visit our website (www.butterworth-labs.co.uk) or send us an email to [email protected]. #analyticalchemistry #gmptesting #methoddevelopment #validation #verification #transfervalidation #gmpprojects #gmpoutsourcing #pharmaceuticals

In the dynamic realm of the pharmaceutical industry, one critical phase demands our attention: the preparation and submission of CMC regulatory documentation. This is where the "recipe" for a drug takes shape – Chemistry, Manufacturing, and Controls converge to ensure consistent, safe medicines. 🧪🍰 Ever wondered about the hidden complexities behind those regulatory submissions? From explicit knowledge to tacit insights, it's a puzzle with high stakes. But fear not, there's a solution: Knowledge Management integrated with your Quality Management System (QMS). 🧠💼 🔍 Let's dive into 4 impactful ways this integration transforms the game: 1️⃣ Identify Gaps Swiftly: Efficiently analyze and align information with regulatory standards. Knowledge Management accelerates the groundwork, providing intelligence for seamless gap analysis. 2️⃣ Unveil Hidden Wisdom: Vital knowledge, both explicit and tacit, at your fingertips. Integration organizes scattered data and insights, like a process map guiding you. 3️⃣ Tacit to Explicit: Capturing subject matter expertise is challenging. With a strategic Knowledge Management approach, these insights are documented, easing translation. 4️⃣ Seamless Collaboration: Regulatory submissions require cross-functional harmony. QMS-powered Knowledge Management ensures a smooth flow of insights across departments. 🎙️ Ready to elevate your expertise? Join us to hear from Raz Eliav, a renowned CMC Development and Regulatory Affairs expert 🎉 With over 12 years of experience, Raz is on a mission to help startups in Drug Development leverage existing knowledge and data technologies to reduce development risks, focusing on Drug Quality and Manufacturing (CMC). 🎙️🔬 𝗙𝗼𝗹𝗹𝗼𝘄 𝘁𝗵𝗲 𝗹𝗶𝗻𝗸 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁 𝘀𝗲𝗰𝘁𝗶𝗼𝗻 𝘁𝗼 𝗿𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗳𝗼𝗿 𝗶𝘁! 👇 Special thanks to our event sponsor, Qualio, a state-of-the-art cloud eQMS, for making this webinar possible. 🙌💊 #gmp #pharma #pharmaceutical #pharmaceuticals #quality #pharmaceuticalmanufacturing

CMC – CHEMISTRY, MANUFACTURING AND CONTROLS To appropriately manufacture a pharmaceutical or biologic specific manufacturing processes, product characteristics, and product testing must be defined in order to ensure that the product is safe, effective and consistent between batches. These activities are known as CMC, chemistry, manufacturing and control. All stages of the drug development life cycle, after drug discovery involve CMC. During preclinical drug development, the proper analytical methods are validated to monitor the product. Stability testing may be initiated, the physicochemical properties of the product are determined, raw materials are chosen and tested. When the drug development process moves into the clinical stage, further analytical method validation is required, and additional characterization of the drug product is needed. After clinical trials the scale up process must ensure that the larger batches of product are the same and meet the same specifications as the drug tested in the clinical trials. After the manufacturing process is qualified, lot release and in process testing will continue to take place. #qa #qms #manufacturing #reasearch #quality #qualityassurance #qualitymanagement #hire #hiretalent #qmstraining #qmsjobs #pharmaceuticalmanufacturing

The Pharma Training Hyderabad www.thepharma.info "Be a Leader in Compliance – Join Our Regulatory Affairs Classes!" #RegulatoryAffairs #RegulatoryCompliance #PharmaTraining #LifeSciences #ComplianceTraining #PharmaEducation #HealthcareCompliance #GxPTraining #RegulatoryClasses #Pharmaceuticals #ClinicalResearch #MedicalDevices #FDACompliance #RegulatoryTraining #QualityAssurance #RegulatoryAffairsTraining #PharmaCourses #BiotechTraining #HealthcareEducation #MedTechTraining

what is CMC in Regulatory Affairs?💊📄📃 📌CMC stands for Chemistry, Manufacturing, and Controls, and it plays a crucial role in regulatory affairs, particularly in the pharmaceutical and biotechnology industries. 📌CMC encompasses the detailed information about the quality and manufacturing processes of a drug product. 📌In regulatory affairs, CMC involves providing comprehensive data on the chemical composition of the drug substance, the manufacturing process, and the controls in place to ensure consistent quality, purity, and potency of the final product. This information is essential for regulatory agencies to evaluate the safety, efficacy, and quality of the drug and to make informed decisions regarding its approval, labeling, and post-market surveillance. 📌Overall, CMC in regulatory affairs ensures that pharmaceutical products meet the required standards for manufacturing quality and consistency, which is essential for ensuring patient safety and public health. #cmc #regulatoryaffairs #pharmaceuticalindustry #chemistrymanufacturingcontrols #cmcinregulatoryaffairs

Increase Tablet Production Pharma Machines & Technology: OCT-NOV’2023 Issue To increase production and minimize downtime cost-effectively and efficiently, multi-tip tooling is the way to go. Although it may be seen as modern, multi-tip tools have been used since tablet presses emerged. Single-station presses used to dominate production, yet they could not keep up with the growing demand due to their limited tooling stations. To read more the link is in the first comment box #pharmaceutical #tooling #cgmp #facilitydesign #pharmaindustry #manufacturers #pharmaceuticalindustry #qualityassurance #qualitycontrol #qualityculture #quality #regulatory #manufacturing #ceomindset #cleaningservices #analytical #validation #laboratory #21cfrpart11 #dataintegrity #documentation #gdprcompliance #traininganddevelopment #collegesanduniversities #pharmacycollege #mpharm #bpharm #pharmacy #mpharm #pharmaceutical #lifescience #chemical #pharma #technology #tabletpress

Regulatory Affairs Chemistry, Manufacturing, and Controls (Reg CMC) is crucial to drug development, approval, and life-cycle management across the pharma industry. Overseeing long-term effects, reviewing proposed experimentation, and understanding the regulatory landscape at large are only some of the areas in which Reg CMC plays a vital role. Interested in learning more? Read 5 takeaways from Bracken’s Senior Partner here: https://lnkd.in/eEqTYtWu #RegCMC #RegulatoryAffairs #lifesciencesindustry #LifeSci