Chris Holt

Are you wondering how quality assurance (QA) and quality control (QC) differ in your quality management system? This article breaks down the key differences, explaining how QA is proactive while QC is reactive, the varying team involvement, and the focus on processes vs. products. Learn how incorporating both QA and QC into your quality management system can save time, reduce costs, and boost customer satisfaction. Find out more here: https://lnkd.in/eWvG7RcM #QualityAssurance #QualityControl #QualityManagement #QMS

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Part II of the article on design controls that depicts how to integrate design control and risk management process. #Risk Management # Design Controls

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The 3 month transition period for Annex 16 ends on September 3rd. From then, sponsors can expect Annex 16 to be applied to GMP Clearance applications that have the manufacturing step of ‘release for supply’ in their scope. There may also be requests for information regarding sites performing confirmation / ‘release for further processing’ as we continue to focus on the overall supply chain for Australia. #gmp #gmpclearance #tga #pics

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Critical Thinking

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"Inspection Ready" often sounds like a buzzword. It shouldn't be. True Inspection Readiness may sound like a mirage, a myth, an unachievable goal, but when everyone does as expected, it's not that hard to achieve. In 3 blogposts I'll bring some ideas, suggestions, tips and tricks to support in your preparation toward a good level of Inspection Readiness. Please check out this first post: https://lnkd.in/ei_6sjPE #InspectionReady #CAPA #QbD

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"Inspection Ready"... So Last week I posted on the follow up of an inspection and the relevance of starting early with Root Cause Analysis and CAPA. This week, I'd like to bring you some tips and tricks on the phase before that... the actual Inspection Visit or Contact. How to be ready for documents, tours, and ... the dreaded interview? (and does that mean true Inspection Readiness...?) https://lnkd.in/eSaBD2_F #InspectionReady #QbD

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At Takeda our mission to create better health for people and a brighter future for the world, our 2024 Annual Integrated Report highlights the ways we are tackling meaningful challenges – and making real progress. For example, 56% of our suppliers are setting science-based targets to reduce greenhouse gas emissions. Across our Planet imperative, our work is guided by a sustainability approach that’s rooted across Takeda’s three corporate philosophy (CP) imperatives: Patient, People, and Planet. Throughout the report, you’ll find stories illustrating value creation aligned with these imperatives. I’m so proud of the team that is delivering for Takeda stakeholders, from advancing equitable access to health care to protecting people and communities from the impacts of climate change. We’re building a healthier planet together. Dive deeper into Takeda's sustainability efforts in the 2024 AIR report: https://lnkd.in/eA2uJFVF #TeamTakeda #climatechange #netzero

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Check out Shawn and Essenvia as excellent sources of information to help you on your quality compliance journey!

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Terms Matter and Differentiate the GxPs

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FDA Warning Letters; inadequate corrective and preventive action (CAPA) looks like a very common theme here. https://lnkd.in/e9d8f4zN Just look at some of them at random, and you will find references to CAPA. I recommend the Automotive Industry Action Group's CQI-20, Effective Problem Solving, as the best CAPA process ever developed. #capa #fdawarningletters

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"Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA 'inspection.' In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. This draft guidance, titled 'Processes and Practices Applicable to Bioresearch Monitoring Inspections,' was prompted by a congressional directive under the Food and Drug Omnibus Reform Act and is intended to provide recommendations that are not otherwise specified in existing publicly available guides and manuals for such inspections (see pgs. 11-12 of the guidance for a list of these resources). It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM), both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance." #FDA #Guidance #CBER #ORA #BIMO #Inspection #IND #NDA #BLA https://lnkd.in/etiDYqvD

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Do you feel the pressure to prove yourself as a leader? Hitting targets and keeping your team on track is great, but are you focusing too much on proving your skills instead of improving yourself for long-term growth? Tackling daily challenges is part of the job, but imagine what you could achieve if you shifted from problem-solving to dreaming big and taking steps towards personal development. Discover more in today’s blog! Click the link to read: https://lnkd.in/gaWbkx84 #Leadership #PersonalGrowth #SelfImprovement #GrowthMindset #TeamSuccess

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