Synthego Corporation’s Post

Do you manage clinical trial with samples and/or Investigational Medicinal Product (IMP) to be temperature controlled? Yes, or yes maybe in the future. From continous improvement perspective and to likely revise/update your Risk Management Plan or your Qualification Audit preparation. Have a look on the Quality Issue shared (thank you Rita Hattemer-Apostel) to understand the consequences of freezer failure when such risk is not properly treated. #QMS #clinicaltrials

Today is the 9th ICH Guideline review post and we still continue with Impurities. 𝐺𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞 𝐅𝐨𝐫 𝐑𝐞𝐬𝐢𝐝𝐮𝐚𝐥 𝐒𝐨𝐥𝐯𝐞𝐧𝐭𝐬 𝐐𝟑𝐂(𝐑𝟗) This guideline contains a lot of additional information on methods for establishing exposure risk, analytical procedures, and lists of solvents with their relevant limits which has not been included in this summary. So, as always, use the summary as a quick overview and do go to the full guideline for implementation 📖. Tomorrow is also the last day of our local school term in Scotland before the start of our summer holiday, so I will be enjoying a bit of time off with my children 🎉. I will try to continue with one review per week until the end of the summer ☀️. So for those who are heading off on holiday soon, have a fabulous time 🏖️, and those that still have a few weeks to go, good luck and hopefully the weather turns better before the start of your break ☔. #Pharma #CMCRegulatory #ICHGuidelines #QA #ContinuousLearning #CTD

"There's no clear answer about the male's role in this ritual, and scientists debate whether the male is compliant in his own sacrificial death." If you ever feel like you're going back and forth with regulators/FDA over something trivial, remember there are PhD's out there disputing whether or not a male praying mantis is COMPLIANT in having its own head munched off after a bit of hanky panky. If you're looking to bring in talent to improve your QMS & Regulatory compliance (and know the truth about mantises) then reach out to me, I won't bite your head off. #quality #regulatory #medicaldevices #prayingmantis

I started my pharma/biotech career many years ago in a CAP/CLIA lab, eventually moving from operations into quality assurance management. One of the routine activities we would do when the College of American Pathologists (CAP) would release their updated checklists was to perform a gap analysis against any new requirements and revisit any others to ensure we reflected our current practices. Each discipline supervisor/manager was asked to go item by item and fill in how the laboratory complied with each requirement on their portion of the checklists. We would then review their checklists together to ensure consensus. I'm certain this was common practice at most CAP-accredited laboratories, but realizing the potential benefits was crucial so that it wasn't relegated to just another checkbox exercise. This served as our storyboard in a way as it helped each department to be able to tell the story of how each requirement was met at our facilities. This was tremendously helpful when it came to facing auditors who would visit. Knowing compliance requirements is one thing, while knowing specifically how your organization meets those requirements is another. Being able to succinctly and cohesively speak about your procedures and processes during audits is incredibly impactful. What are some audit readiness and training strategies that you've seen or used that were successful? I expect these will be varied as every organization is different culturally and dependent on the services you are providing as well. #qualityassurance #regulatorycompliance

Hear from Faz Jalali on what led him to start EHO Consulting with Alex Thompson. Reflecting on my career journey, I often contemplate the twists and turns that led me to where I am today. Like everyone who becomes a hazardous materials consultant, I 'fell' into it!   At first, I didn't see its value, so I tried to leave the industry by expanding my knowledge and gaining qualifications in three other fields. But, it became apparent that the demand for my skills lay in the hazardous materials domain. So, rather than resisting hazmat consulting, I embraced it by embarking on another course: an MSc in occupational hygiene and toxicology (Yes, I've spent a lot of money on education!).   I often share the importance of our role as hazardous materials consultants and occupational hygienists with new trainees. We're not just practitioners but guardians of health at work, preventing potential illnesses among workers exposed to dangerous chemicals and contaminants. While the impact of our efforts may only sometimes be apparent, we are, in essence, saving lives.   I'm so proud of what Alex Thompson and I started seven years ago with EHO Consulting. We're both excited to keep growing the business while retaining our core values.

In the fast-paced world of laboratory work, keeping up with the latest in best practices and protocols for an effective #QC program can be challenging. Discover innovation-focused articles and best practice tips to help optimize lab quality control. Dive into our newsletter, including highlights from Bio-Rad's Quality Controls Learning Center and arm your team with QC knowledge and insights: https://bit.ly/3x7c63B #QCEducation #QualityControl #ClinicalLaboratory #ContinuousLearning

In a toxic environment at work? I recommend radical self care, document and report abusive behavior, show compassion when opportunities arise, yet insist on time, space and communication boundaries that help you feel safe. Most of all-GET OUT! Go where you’re appreciated and accepted. #workculture #wellnessatwork #adaptability #socialawareness #OccupationHumanity

This is really succinct bullet list to help you manage a challenging relationship with a manger.

Starting a new #QualityControl or reagent lot is a critical point in the workflow of a lab. Practices can vary during this process and changes have the potential to affect patient results and lab operations. Watch best practices to perform QC lot changes: https://bit.ly/3VmSmTT #LabQuality #LabManagement #ClinicalLabTesting #QualityControl #ReliableResults #ContinuousLearning

🧪🔬Process knowledge and technical knowledge are crucial for contamination prevention... Here are a few things to consider... 🔍Process Knowledge: - Identify contamination entry points - Recognize microorganism growth areas - Evaluate viral proliferation potential - Assess contamination reduction capabilities 🔧Technical Knowledge: - Apply aseptic processing principles - Process, facility, and equipment design - Ensure raw material quality - Apply quality risk management principles - Implement cleaning and sterilization principles 💡 Together we can minimize contamination events, ensure product quality and protect patients. #PharmaQuality #GMP #ContaminationControl