TheLearningReservoir

To help you prepare for MDSAP audits, we are sharing our free ebook, "𝐄𝐯𝐞𝐫𝐲𝐭𝐡𝐢𝐧𝐠 𝐘𝐨𝐮 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐊𝐧𝐨𝐰 𝐀𝐛𝐨𝐮𝐭 𝐌𝐃𝐒𝐀𝐏." It breaks down the audit model and critical failure points. 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐡𝐞𝐫𝐞: thelearningreservoir.com/ebooks-for-med… #CAPA #MDSAP #ISO13485

New FDA Form 483 posted to our database: Alps Pharmaceutical Ind. Co., Ltd. [Furukawachokamino / Japan] fda483s.com/fdadocs/alps-p…

New FDA Form 483 posted to our database: Tianish Laboratories Private Limited [Isnapur / India] fda483s.com/fdadocs/tianis…

MDSAP audits often feel more complex than they need to be. Understanding the audit assessment cycle makes preparation more focused and less reactive. 🎥 Step-by-step overview: youtube.com/watch?v=L08aM8…

The audit does not end when the questions stop. A well-run audit closing meeting helps teams clearly understand findings, next steps and priorities for improvement. 🎥 Explained here: youtube.com/watch?v=Bs9gPY…

Strong audit teams don’t happen by accident. Good auditors need communication skills and process understanding — not just technical knowledge. 🎥 8 practical tips here: youtube.com/watch?v=ccHXY4…

ISO 13485 internal audits are not just about compliance. Used properly, they help organisations understand how their quality system actually works in practice. 🎥 Explained here: youtube.com/watch?v=V18T3j…

New FDA Form 483 posted to our database: SpecGx LLC [Saint Louis / United States of America] fda483s.com/fdadocs/specgx…

HACCP prerequisite programmes are the foundation of food safety systems. When PRPs are weak or poorly understood, even a good HACCP plan will fail in practice. 🎥 Short explanation here: youtube.com/watch?v=fC9G7Y…

A Closer Look At US FDA’s 58 Novel Approvals In 2025 — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/4kg3j vist.ly/4kg3k

New FDA Form 483 posted to our database: Boehringer Ingelheim Pharmaceuticals, Inc. [Ridgefield / United States of America] fda483s.com/fdadocs/boehri…

A good onboarding process not only enhances employee productivity but helps increase loyalty and engagement—and decreases turnover. So why do so many companies botch it? s.hbr.org/44mk1I1

Reskilling is a strategic imperative. s.hbr.org/4puiXKr

Here's @JDevonshire with today's #UKmfg headlines 👉 themanufacturer.com/articles/daily… Stories include @Cummins @CarfulanGroup @Paragraf_Gr & more #shoutaboutUKMfg

New FDA Form 483 posted to our database: Navarro Pecan Holdings, LLC [Corsicana / United States of America] fda483s.com/fdadocs/navarr…

FMEA is often treated as a form to complete instead of a way to think about risk. At its core, FMEA is about identifying where things could fail before problems reach the customer. 🎥 Explained here: youtube.com/watch?v=2_qMDm…

𝐖𝐢𝐬𝐡𝐢𝐧𝐠 𝐞𝐯𝐞𝐫𝐲𝐨𝐧𝐞 𝐚 𝐯𝐞𝐫𝐲 𝐇𝐚𝐩𝐩𝐲 𝐍𝐞𝐰 𝐘𝐞𝐚𝐫. Thank you to all the organisations, learners and partners who engaged with us over the past year. We look forward to supporting manufacturing teams again in the year ahead.

What is FMEA and why do so many teams get it wrong? FMEA is about identifying risk before it becomes a problem — not filling out a form after the fact. 🎥 Explained here: youtu.be/2_qMDmbq1x8?si…

𝐍𝐞𝐰 𝐕𝐢𝐝𝐞𝐨: 𝐖𝐡𝐚𝐭 𝐢𝐬 𝐈𝐀𝐓𝐅 𝟏𝟔𝟗𝟒𝟗? 𝐀 𝐂𝐥𝐞𝐚𝐫 𝐈𝐧𝐭𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐭𝐨 𝐭𝐡𝐞 𝐀𝐮𝐭𝐨𝐦𝐨𝐭𝐢𝐯𝐞 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝 👉🏿m.youtube.com/watch?v=juNnPT… #IATF16949 #AutomotiveIndustry #QualityManagement #Manufacturing

Three Lots of Famotidine Injection USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial by Fresenius Kabi: Recall - Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples fda.gov/safety/recalls…

New FDA Form 483 posted to our database: True Botanica, LLC [Hartland / United States of America] fda483s.com/fdadocs/true-b…