📢 𝑽𝒆𝒕𝒆𝒓𝒊𝒏𝒂𝒓𝒚 𝑴𝒆𝒅𝒊𝒄𝒂𝒍 𝑫𝒆𝒗𝒊𝒄𝒆𝒔: 𝑵𝒆𝒘 𝑩𝒍𝒐𝒈 𝑨𝒍𝒆𝒓𝒕! ↳ Check out the latest blog on the 𝑰𝒕𝒂𝒍𝒊𝒂𝒏 𝑮𝒖𝒊𝒅𝒆𝒍𝒊𝒏𝒆𝒔 𝒐𝒏 𝑺𝒂𝒇𝒆𝒕𝒚 𝒂𝒏𝒅 𝑷𝒆𝒓𝒇𝒐𝒓𝒎𝒂𝒏𝒄𝒆 𝒐𝒇 𝑽𝒆𝒕𝒆𝒓𝒊𝒏𝒂𝒓𝒚 𝑫𝒆𝒗𝒊𝒄𝒆𝒔, by Leonardo Giraudo, Pharmacovigilance Compliance Expert PQE Group ↳ Learn more about the gaps these guidelines aim to fill and the benefits they offer to manufacturers, operators, and ultimately, animal patients 🐾 ↳ The read highlights 𝒌𝒆𝒚 𝒂𝒔𝒑𝒆𝒄𝒕𝒔 such as the Risk Management Approach, Labelling, and Safety measures outlined in the guidelines. 👉🏼 Click to learn more: https://hubs.ly/Q02HW8QQ0 #VeterinaryDevices #Regulations #Safety #Performance #OneHealth #RiskManagement
Chi siamo
WHO WE ARE PQE Group is a women-owned Contract Quality Organisation and Complete Quality Solution provider for GCP, GLP, GMP, GVP & GDP areas in the Life Science Industry. As an international group of over 2000 employees (40% of whom are female), we are composed of 43 nationalities and have experience working in more than 25 languages. PQE Group has an excellent history of supporting companies of all sizes and exceeding compliance standards from our 40 global offices. We are dedicated to creating value for our customers by putting our multidisciplinary teams and knowledge at their service, allowing our clients to achieve and maintain compliance with the latest regulations, and contributing to creating a safer pharmaceutical environment. WHAT WE DO Since 1998, PQE Group has successfully completed more than 15,000 projects worldwide while serving our 1400 medical device and pharmaceutical clients. We deliver turnkey quality solutions while focusing on offering exceptional cost-effectiveness and maintaining the highest quality of care for our customers. With our extensive experience, effective project management, and exceptional cost-effectiveness, PQE’s solutions are proven to be the winning combination for global corporations of all sizes. WHERE WE’RE GOING We at PQE Group strongly believe that our success is tied to the well-being of the communities and environment around us. We understand that change must come from ourselves first – so we take action through social responsibility goals like sustainable development, gender equality, protection of the environment, and health and safety. PQE Group actively works to achieve our ambitious objectives to foster social change and environmental stability by collaborating with important programs and charity associations around the world.
- Sito Web
-
http://www2.pqegroup.com
Link esterno per PQE Group
- Settore
- Consulenza e servizi aziendali
- Dimensioni dell’azienda
- 1001 - 5000 dipendenti
- Sede principale
- Reggello, FI
- Tipo
- Società privata non quotata
- Data di fondazione
- 1998
- Settori di competenza
- GAMP, CSV, Validation, Compliance, Qualification, Regulatory Affairs, Engineering, 21 CFR Part 11, Pharmaceutical, Medical Devices, Biotech, Life Sciences, Quality, Audit, SAP, GDPR, Data Integrity, Digital Governance, Cybersecurity, Serialization, IT, IT Infrastructure e Marketing
Località
Dipendenti presso PQE Group
Aggiornamenti
-
𝗙𝗿𝗼𝗺 𝘁𝗵𝗲 𝗖𝗿𝗼𝘄𝗱𝗦𝘁𝗿𝗶𝗸𝗲 𝗢𝘂𝘁𝗮𝗴𝗲 𝘁𝗼 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗥𝗲𝘀𝗶𝗹𝗶𝗲𝗻𝗰𝗲, a blog by PQE Group's Partner & Principal Consultant, Danilo Maruccia, provides a comprehensive overview of critical points from the incident and highlights the unique vulnerabilities faced by the life sciences sector. 𝐄𝐱𝐭𝐫𝐚 𝐟𝐨𝐜𝐮𝐬 placed on the 𝐃𝐢𝐫𝐞𝐜𝐭𝐢𝐯𝐞 (𝐄𝐔) 𝟐𝟎𝟐𝟐/𝟐𝟓𝟓𝟓, referred to as 𝐍𝐈𝐒𝟐, which EU Member States must transpose by 17 October 2024, 𝐢𝐧𝐜𝐥𝐮𝐝𝐢𝐧𝐠 𝐰𝐢𝐭𝐡𝐢𝐧 𝐢𝐭𝐬 𝐬𝐜𝐨𝐩𝐞 𝐥𝐢𝐟𝐞 𝐬𝐜𝐢𝐞𝐧𝐜𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬. Read for valuable insights into proactive measures to ensure readiness and resilience against future events: https://hubs.ly/Q02HMLRB0 #Cybersecurity #OperationalResilience #Businesscontinuity #NIS2 #PQEGroup #Readiness #EURegulations
From CrowdStrike Outage to Operational Resilience: Are You Prepared?
blog.pqegroup.com
-
🌍 𝑬𝑺𝑮 𝑹𝒆𝒑𝒐𝒓𝒕𝒊𝒏𝒈: 𝒑𝒐𝒍𝒍 𝒔𝒆𝒓𝒊𝒆𝒔 Environmental, Social, and Governance (ESG) initiatives gradually become more important for businesses. In the following series of polls, we at PQE Group hope to understand the perception currently held by life science companies on ESG initiatives and reporting. 𝒀𝒐𝒖𝒓 𝒗𝒐𝒕𝒆 𝒄𝒐𝒖𝒏𝒕𝒔 to share a better understanding, awareness, and action.
Questo contenuto non è disponibile qui
Accedi a questo contenuto e molto altro nell’app LinkedIn
-
🎬 Introducing Episode 2 of 'Q Factor Documentaries' brought to you by PQE Group! 🌟 Meet Elisabetta Biavati, an extraordinary Italian woman navigating life with challenging conditions such as Arnold Chiari, Ataxia, and Small Fiber Neuropathy🌟 ⮚ Despite chronic pain, tremors, and severe headaches, Elisabetta has found remarkable relief through medical cannabis. Her story is a powerful testament to the life-changing potential of cannabinoid therapy. ⮚ In this episode, we'll share a first-hand testimony for better recognition of medical cannabis and explore the role of Quality Culture in ensuring patients receive the highest standard of treatment 🔗 Watch now: https://hubs.ly/Q02Hpjn60 #PQEGroup #QualityCulture #PatientCare #MedicalCannabis #CannabinoidTherapy #ChronicPainRelief #PatientStories
Q Factor: Quality Medical Cannabis for Patients
https://www.youtube.com/
-
𝐓𝐨𝐝𝐚𝐲'𝐬 𝐰𝐢𝐝𝐞𝐬𝐩𝐫𝐞𝐚𝐝 𝐈𝐓 𝐨𝐮𝐭𝐚𝐠𝐞, 𝐰𝐡𝐢𝐜𝐡 𝐞𝐯𝐞𝐧 𝐢𝐦𝐩𝐚𝐜𝐭𝐞𝐝 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐬𝐲𝐬𝐭𝐞𝐦𝐬, serves as a stark reminder of our digital vulnerabilities. While we often discuss the risks of cyberattacks, today's events highlight that even seemingly minor software glitches can have cascading consequences. In the life science sector, where lives depend on the seamless operation of technology, these outages can be particularly devastating. Delayed patient care, inaccessible medical records, and disrupted communication channels can all result from IT failures. At PQE Group, we understand the critical importance of robust, reliable IT infrastructure in healthcare. Our expertise in IT resilience planning and IT Service Continuity is designed for the life science industry to mitigate these risks and ensure the continuity of patient care. 𝐬𝐡𝐚𝐫𝐞 𝐰𝐢𝐭𝐡 𝐮𝐬 𝐲𝐨𝐮𝐫 𝐭𝐡𝐨𝐮𝐠𝐡𝐭𝐬💭🤔 In your opinion, what are the long-term measures to take in order to be ready ahead of time for an unexpected IT outage? https://hubs.ly/Q02HfgJp0 #IToutage #HealthcareIT #DigitalResilience #BusinessContinuity #PQE
Digital Governance - PQE Group
https://www2.pqegroup.com
-
𝐄𝐱𝐜𝐢𝐭𝐞𝐝 𝐭𝐨 𝐬𝐡𝐚𝐫𝐞 📸 𝐟𝐫𝐞𝐬𝐡 𝐩𝐡𝐨𝐭𝐨𝐬 𝐟𝐫𝐨𝐦 PQE Group's 𝐟𝐢𝐫𝐬𝐭 𝐔𝐒 𝐑𝐨𝐚𝐝𝐒𝐡𝐨𝐰 𝐞𝐯𝐞𝐧𝐭, 𝐰𝐡𝐢𝐜𝐡 𝐭𝐨𝐨𝐤 𝐩𝐥𝐚𝐜𝐞 𝐲𝐞𝐬𝐭𝐞𝐫𝐝𝐚𝐲 𝐢𝐧 𝐑𝐨𝐜𝐤𝐯𝐢𝐥𝐥𝐞, 𝐌𝐃! 🙏 A big thanks to everyone who took part in this inspiring event, whether as an attendee, panelist, or organizer. ➜ Yesterday, we had the pleasure of discussing the future of innovations in life sciences with leading voices in the industry. ➜ The discussions were moderated by Bill Paulson, Publisher at IPQ, and the speakers included Gilda D'Incerti, CEO & Founder of PQE Group, Kelly Schulz, CEO of Maryland Tech Council, and Hamid Teimourian, Site Energy Program Lead at AstraZeneca. 🙏 We are more than grateful for the success of this event and look forward to creating similar opportunities to exchange ideas, provoke thought, and foster further innovation. #LifeSciences #Innovation #PQEGroup #RoadShow #KnowledgeSharing #FutureOfScience
-
-
📌 𝗔𝗜: 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗜𝗻 𝗟𝗶𝗳𝗲 𝗦𝗰𝗶𝗲𝗻𝗰𝗲𝘀 As Artificial Intelligence (AI) continues to advance, concerns about pre-existing biases, ethical issues, and lack of transparency have impeded its full adoption in heavily regulated industries like pharmaceuticals. While regulatory bodies are actively observing the advancements, a comprehensive framework, specifically targeting AI applications, is still in development. Following the latest partnership announcement between PQE Group and GENAIZ, we invite you to read a co-written blog that covers key topics including: ➡️Regulatory Bodies’ Current Perspectives ➡️AI and Advanced Manufacturing ➡️The Life Science Companies’ Race Towards Revolutionized Healthcare Read more here: https://hubs.ly/Q02GVYl_0 #GENAIZ #PQEGroup #AI #LifeSciences #Technology #AdvancedManufacturing #EthicalAI #AIChallenges
AI, Regulation and Compliance Challenges In Life Sciences
blog.pqegroup.com
-
𝐑𝐞𝐚𝐝𝐲 𝐭𝐨 𝐚𝐬𝐬𝐞𝐬𝐬 𝐭𝐡𝐞 𝐬𝐭𝐚𝐭𝐞 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 (𝐅𝐫𝐞𝐞)? 🧐 𝐖𝐞'𝐯𝐞 𝐠𝐨𝐭 𝐲𝐨𝐮 𝐜𝐨𝐯𝐞𝐫𝐞𝐝! ✅ ⮱ Maintaining well-managed, accurate, consistent, and reliable data in the life science industry is crucial for ensuring the efficiency and safety of your products. ⮱ 𝐓𝐡𝐚𝐭’𝐬 𝐰𝐡𝐲 𝐰𝐞’𝐯𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐞𝐝 𝐚 𝐐𝐮𝐢𝐜𝐤 𝐚𝐧𝐝 𝐅𝐫𝐞𝐞 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭! By taking the assessment, you will be able to identify and evaluate gaps, gain actionable insights, align with regulatory requirements, and streamline your processes. ⮱ 𝐑𝐞𝐚𝐝𝐲?! >>>>> 𝐆𝐨! 🚀 🔗 https://hubs.ly/Q02GKXCK0 #Dataintegrity #DIassessment #LifeSciences #Compliance #DataManagement #PQEGroup
Data Integrity Self Assessment
focus.pqegroup.com
-
𝐅𝐨𝐥𝐥𝐨𝐰 𝐲𝐨𝐮𝐫 𝐠𝐫𝐞𝐚𝐭𝐞𝐬𝐭 𝐩𝐚𝐬𝐬𝐢𝐨𝐧𝐬! ✨ 👉🏼 Check out the beautiful letter shared by Marco Badiali, MD Compliance Manager, with Luisa Cabria, Global VP of MD Compliance & Regulatory Affairs Senior Equity Partner, 𝐟𝐞𝐚𝐭𝐮𝐫𝐢𝐧𝐠 𝐡𝐢𝐬 𝐮𝐧𝐢𝐪𝐮𝐞 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 𝐯𝐨𝐥𝐮𝐧𝐭𝐞𝐞𝐫𝐢𝐧𝐠 𝐟𝐨𝐫 𝐚𝐧 𝐍𝐆𝐎 𝐢𝐧 𝐈𝐧𝐝𝐨𝐧𝐞𝐬𝐢𝐚!
There is no better time than the present to follow your greatest passions! I received this update from my dear friend and colleague Marco Badiali, who is currently taking a sabbatical year to volunteer across Asia. I wish I could receive messages like this every day—they give me extraordinary PQE Group pride! -- Hi, Luisa, how are you doing? For the last few weeks, before returning to Italy, we have been on Sumatra island and volunteering for an NGO. I was glad to send you this photo since, on the very day of the group photo, I was wearing the PQE T-shirt. Here, in particular, we delved into the great natural disaster that is being consumed by intensive palm oil plantations. The NGO is trying to financially support farmers in converting intensive plantations back to more natural crops such as rubber trees and durian (especially the latter two are critical for orangutan habitat and wildlife in general). On photo day, we were planting trees!!!! The fulfillment that comes from giving back is what drives our company and communities forward. I’m glad to see you making a positive impact and representing our PQE Group team in the best way, Marco!
-
-
2024: 𝑫𝒂𝒕𝒂 𝑰𝒏𝒕𝒆𝒈𝒓𝒊𝒕𝒚 𝑮𝒂𝒑 𝑨𝒔𝒔𝒆𝒔𝒔𝒎𝒆𝒏𝒕 𝒊𝒔 𝑴𝒂𝒌𝒊𝒏𝒈 𝒂 𝑪𝒐𝒎𝒆𝒃𝒂𝒄𝒌 📈 𝒀𝒆𝒔, 𝒚𝒐𝒖 𝒂𝒓𝒆 𝒓𝒊𝒈𝒉𝒕—𝒊𝒕 𝒏𝒆𝒗𝒆𝒓 𝒘𝒆𝒏𝒕 𝒂𝒘𝒂𝒚 to define it a comeback, but while data integrity (DI) Gap Assessment experienced its 'golden age' before COVID-19, the pandemic shifted many activities to remote work, including computerized systems analysis. While this shift was necessary, the effectiveness often didn't match the impact of direct, on-site evaluations. Fast-forward to 𝟐𝟎𝟐𝟒, and 𝐝𝐚𝐭𝐚 𝐢𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐆𝐚𝐩 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐢𝐬 𝐨𝐧𝐜𝐞 𝐚𝐠𝐚𝐢𝐧 𝐛𝐞𝐜𝐨𝐦𝐢𝐧𝐠 𝐜𝐞𝐧𝐭𝐫𝐚𝐥 to helping pharmaceutical companies identify gaps and define remedial actions to ensure drug quality. Read the latest blog by Alessio Petrucci, Principal Consultant, CSV/CSA & Data Integrity Advisor Engineer, Senior Associate Partner, 𝐭𝐨 𝐮𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝 𝐰𝐡𝐲 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐬𝐡𝐨𝐮𝐥𝐝 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫 𝐩𝐞𝐫𝐟𝐨𝐫𝐦𝐢𝐧𝐠 𝐚 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐆𝐚𝐩 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐚𝐧𝐝 𝐡𝐨𝐰 𝐭𝐨 𝐝𝐨 𝐢𝐭 𝐦𝐨𝐬𝐭 𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞𝐥𝐲. Explore further: https://hubs.ly/Q02G9b9G0 #DataIntegrity #Pharmaceuticals #QualityAssurance #CSV #CSA #Compliance #PQEGroup
The Importance of Gap Assessment on Data Integrity Before an FDA Inspection
blog.pqegroup.com