On This Week's Testing Thursday: Embracing the Future: The Impact of Cannabis as a Schedule III Substance and the Crucial Role of cGMP 211 Certification In this blog, we explore the potential implications of cannabis becoming a Schedule III substance and why obtaining current Good Manufacturing Practices (cGMP) 211 Certification from an accredited certifying body is crucial for ensuring the longevity and success of cannabis businesses. ➡️ Learn more about the knowns and unknowns: https://ow.ly/uua750Qzjpt
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STANDARDS ARE COMING! Check out the latest blog I wrote at Digamma Consulting. cGMP and ISO standards are indeed ahead for the cannabis industry. For example, Deleware's new application process requires GMP standards, starting right with explaining how you will comply in the application. Get ready! Part 2 comes out in a few days. Share, please!
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Join us & our friends at Gilero on Thursday April 18th from 11:00 am-12:00 pm (EDT) to discuss the combination product cGMP operating system requirements that support development, manufacturing, premarket regulatory evaluation, and commercialization of combination products. Register & learn more about the webinar here: https://bit.ly/4aKi9JS #CombinationProductWebinar #RegulatoryCompliance #MedicalDeviceManufacturing #CommercializationStrategies #JoinUsOnline
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Our quality systems, validated and audited by biopharma manufacturers and regulatory bodies worldwide, underscore our commitment to excellence. We prioritize quality at every stage, from raw material procurement through cGMP manufacturing at various scales, to handling and distribution. Learn more https://ow.ly/yK9o50Sj7I9 #AvantorSetsScienceInMotion
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🌿As the cannabis industry evolves, so does the regulatory landscape governing its operations. With the potential reclassification of cannabis to Schedule III under the Controlled Substances Act, cannabis testing labs and product manufacturers must brace for significant changes. 🔬 🗝️Understanding the complexities of transitioning to new cannabis regulations is key, especially regarding compliance with Current Good Manufacturing Practices (cGMP) and International Organization for Standardization (ISO) standards. Stay informed on how these changes could impact operations and what businesses need to know moving forward. 🔗 Read more👉 https://lnkd.in/dFV4C9wA #CannabisIndustry #RegulatoryChanges
Schedule III: Cannabis Regulatory Disruptions Ahead
digammaconsulting.com
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🌟𝐞-𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐂𝐨𝐮𝐫𝐬𝐞 - 𝐃𝐫𝐮𝐠/𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐜𝐆𝐌𝐏 𝐑𝐞𝐬𝐞𝐫𝐯𝐞 𝐒𝐚𝐦𝐩𝐥𝐞𝐬 (𝟐𝟏 𝐂𝐅𝐑 𝟐𝟏𝟏.𝟏𝟕𝟎) 🌟 Dive into the intricacies of FDA requirements for reserve samples (21 CFR 211.170) specific to drug/device combination products. Gain insights into their importance in verifying test results and meeting regulatory standards. 👉 Enroll now: https://lnkd.in/e26VFUXp ⏱️ 𝐅𝐥𝐞𝐱𝐢𝐛𝐥𝐞 𝐃𝐮𝐫𝐚𝐭𝐢𝐨𝐧: Complete the course within 2-3 hours, allowing you to learn at your own pace and fit your schedule. 📜 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐞 𝐨𝐟 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐢𝐨𝐧: Earn a certificate upon successful completion of the course quiz, validating your expertise in this essential aspect of drug/device combination product manufacturing. Enroll now and embark on a journey to enhance your understanding of FDA cGMP requirements for reserve samples in drug/device combination products! 🚀 #FDACompliance #DrugDeviceCombination #fda
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Safe and Consistent Cannabis Products: A GMP Collective Webinar on Fit for Purpose Testing Methods Industry experts in the latest webinar from the GMP Collective discussed the importance of using ‘fit for purpose’ testing methods for cannabis products, the connection to accreditation bodies, tips and solutions for testing laboratories, and more. ➡️ Read our coverage of this important topic in #cannabistesting: https://ow.ly/Sek850R9ql1
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Verifying the dispensing accuracy of your automated liquid handlers is a must for compliance to current regulatory standards for calibration (ISO, GMP, CAP, CLIA). Join us at Making Pharmaceuticals from 23rd - 24th April, Coventry (STAND 704) to discover how the Artel Multichannel Verification System (MVS®) is utilised by leading companies to ensure compliance. #assayoptimisation #precisionautomation #liquidhandling
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Looking forward to this workshop on navigating regulatory pathways for GLP-1 peptides and biosimilar insulin to ensure successful FDA approval!
Attend a three hour, private, interactive workshop to understand the regulatory considerations for ushering new GLP-1 drugs through the FDA minefield!
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The ability to clean proteinaceous soils is a critical aspect of maintaining pharmaceutical equipment to ensure product quality and safety. Between 2006-2019, the FDA generated more than 3,078 Form 483 citations related to the FDA’s Code 21 CFR 211.67 and 21 CFR.182 for equipment cleaning, maintenance, and use log. To avoid FDA-related citations and ensure product quality and safety, it is important to use an effective, validatable cleaning agent in equipment cleaning and maintenance. This white paper takes a closer look at selecting cleaning detergents. #TechnicalTip #PharmaceuticalEquipmentandCleaning #QualityAssurance #CleaningValidation #STERISLifeSciences #STERIS #Pakistan #SANTISLabCo
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Find everything a pharma manufacturer needs to know about FDA and ISO compliance in one handy resource. #regulatory #compliance #pharma #manufacturing https://ow.ly/PgHp50QAiky
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