Andrew M. Trippi’s Post

Process improvement and company growth start with a robust quality system. Understand the importance of a quality journey for your organization and products in this complimentary whitepaper: https://azzur.co/3IOCAcS #QualityManagementSystem #LifeScience #QualitySystems #cGMP #FDA

Implement an automated Quality Management System with the automated BPA Solutions, https://lnkd.in/eSaqWRB3 ✨ 4 Questions to determine the health of your company’s QMS, https://lnkd.in/dFvhY4_G #iso9001 #iso14001 #iso45001 #eQMS #audit #qualitymanagement

Prepare for the #iso13485 audit with the automated BPAMedical365®, https://lnkd.in/dUkTS5PZ ⭐ How to Prepare for and Conduct an ISO 13485 Internal QMS Audit, https://lnkd.in/dFejBeND #gmp #medtech #pharma #regulatoryaffairs #qualitycontrol

ISO 9001 Is Changing—Are You Ready? Big updates are coming to the ISO 9001 standard, and they could have a major impact on your business. Are you prepared for what's ahead? Join ISO Working Group member Mark Swanson and partner Steve Gompertz as they break down the revision process, share insights on proposed changes, and help you get ahead of the curve. What you’ll learn: ✅ The ISO 9000/9001 revision timeline and why updates are being made ✅ Key changes likely to affect quality and operations teams ✅ How the growth from 6 to 20 fundamentals in ISO 9000 could reshape ISO 9001, ISO 13485, and other quality management system requirements (e.g., FDA 21 CFR Part 820 and EU MDR)—and how to prepare ✅ How proposed changes align with emerging trends in #manufacturing, including the move to an IMS (Integrated Management System) Don’t let these changes catch you off guard. Secure your spot today and ensure your Quality and Operations teams are ready for 2025 and beyond! https://hubs.li/Q030pk7w0 #intellectQMS #ISO #webinar

ISO 9001 is Changing, are ready or already behind? ISO 9001 revisions are in motion, and the upcoming changes could impact your business. Are you prepared? Join ISO Working Group expert Mark Swanson and partner Steve Gompertz as they break down the review process, share proposed updates, and reveal how these changes could reshape quality management in 2025 and beyond. Don’t wait—secure your spot today! https://hubs.li/Q032wbjr0

On 6th August, the Medical Device Single Audit Program (MDSAP) audit approach document was updated. The MDSAP audit approach document was updated from version 008 to 009. Changes made relate to guidance for specific country requirements for Australia, these have either been edited or removed. Minor changes have also been made to references and formatting. MDSAP was developed to conduct audits of quality management systems, specifically of medical device manufacturers. The program allows for a single audit to cover the requirements of BS EN ISO 13485:2016 alongside specific regulatory requirements of participating jurisdictions - Australia, Brazil, Canada, Japan and USA. This approach reduces the need for multiple audits. The updated document can be found here: https://lnkd.in/eVrP2QfU If you need support with MDSAP, or any other aspects of medical device regulation, or drug development contact tranScrip to discuss how we can help. #medicaldevices #MDSAP #regulatoryaffairs #audit

Are you ready for the ISO 9001 changes? Join our webinar tomorrow to learn more about the upcoming changes and make sure you are prepared!

ICYMI: 21CFR820 and ISO 13485 have never been so closely aligned. https://lnkd.in/eFkEnJ4H

Take an APEX Minute to consider thought-provoking perspectives on the intersection of business, operations, and quality to improve patient care. Incorporating Process Thinking to Regulatory Changes As new regulations are introduced into the med/pharma landscape, operations and quality departments may find themselves under stress to quickly assess the impact of changes, develop an implementation strategy, and then execute changes to the QMS and the operation.  Ideally, doing so without impacting production scheduling, product availability, or process efficiency. Some considerations on this topic: ·       Understand “how work gets done”. This may require a process flow map to visualize work steps and develop an understanding of all the different process attributes. ·       Understand “why work gets done”. Are some of the steps needed? Are they from legacy processes and part of the “we’ve always done it this way” culture? Simply stated, adding new requirements within existing procedures may be likened to applying an adhesive bandage onto a “process wound”. The solution may provide a level of compliance, but most likely complexity has been introduced to the process, leading to increased risk of variable performance and nonconformance. Thinking through process steps of how the additional work will be performed, by whom, and in what sequence or inter-relation with other steps can reduce these risks. If you’d like to explore these topics more, contact us for a chat. We’re passionate about process performance excellence. ___________ APEX Performance Excellence Group provides innovative, process-focused approaches and methodologies to medical device and pharmaceutical companies to enable profit and growth strategies while ensuring regulatory compliance. Connect with us to learn more and sleep better at night. https://lnkd.in/gYmvwBni www.APEXpeg.com #ContinuousImprovement #BusinessExcellence #QualitySystem #APEXminute

Why Choose an ISO/IEC 17025 Accredited Laboratory Backed by ILAC? 🌐✨ In the world of calibration and measurements, trust is non-negotiable. The results you receive from your provider can make or break your success. That’s why choosing a laboratory accredited under ISO/IEC 17025, with ILAC support, is more than just a formality—it’s a commitment to excellence. 🏆 💡 3 Reasons to Prioritize Accredited Laboratories: 1️⃣ Reliable Results: Accreditation ensures that procedures, equipment, and personnel meet the most stringent international standards, guaranteeing accurate and trustworthy measurements. 2️⃣ Global Recognition: With ILAC support, certificates are accepted worldwide under the ILAC MRA agreement, saving you time and eliminating additional costs for recalibration in other countries. 🌍✔️ 3️⃣ Risk-Free Operations: An accredited laboratory minimizes measurement errors and provides dependable data for critical decisions in sectors where precision is vital, like healthcare, automotive, or manufacturing. 📌 Key Fact: Choosing a provider with ISO/IEC 17025 accreditation shows that you value quality and metrological traceability—indispensable elements for staying competitive in a global market. Do you already work with an accredited laboratory? 💬 Share your experience and help others understand the importance of this accreditation for their operations. 👉 Tag your team or someone who needs to know this and start making confident decisions. 🚀 #ISO17025 #ILAC #Calibration #Metrology #Quality #GlobalTrust