Quality Executive Partners, Inc. (QxP?)

Don’t be Fooled? - Assessments go far Beyond Audits in Evaluating Compliance Risk in Your Operations. For pharmaceutical/biopharmaceutical manufacturers, understanding your operations in detail is crucial—not just for compliance but for long-term success in meeting patient needs. That's where a baseline assessment makes all the difference. When thinking about hiring a third-party to "audit" your operation, consider this:?An audit is the selective sampling of parts of your operation at a point in time—a snapshot. It will not give you the confidence of your entire state of control. It will not provide the overall operational risks to meeting compliance expectations. It will not connect the dots within your quality systems to demonstrate the relationships of the systems in action. QxP’s baseline assessment tool enables us to dive deeply into quality systems, production controls, testing, and engineering systems in a unique and connected way. The baseline assessment is far more comprehensive and allows you to assess your current state in relation to regulatory expectations and industry’s best practices. Our methodology involves historical data analysis, interviews with key personnel, and a thorough lifecycle review—from development to patient delivery. As the industry evolves, partnering with QxP's team that takes a strategic yet pragmatic approach to quality isn't just helpful—it's essential. Baseline assessments provide the kind of actionable insights that builds consistency and connection in your operations, ensuring product safety and patient outcomes. Take your first step with Quality Executive Partners.? Connect with QxP COO, Brian Duncan here on LinkedIn Learn More: https://lnkd.in/eNCy9MFT

From our opening dinner toast to strategy sessions, brainstorming, and even a hands-on chocolate-making experience, last week was about more than just meetings—it was about strengthening the connections that make us who we are. Our Quality Executive Partners consulting and Virtuosi? education teams came together with a shared commitment: delivering the highest standards in pharmaceutical consulting and education to support the development of quality, often life-saving, medicines for patients. Collaboration, insight, and a little bit of fun—we’re energized for the road ahead! QxP: https://lnkd.in/eRRvUwZ4 Virtuosi: https://lnkd.in/e8HYiy59

CELEBRATING THE WOMEN OF QxP & VIRTUOSI Today, we recognize the incredible women of Quality Executive Partners, Inc. (QxP?) and Virtuosi? who are shaping the future of the pharmaceutical industry. From our President & CEO, Crystal Mersh, to the many women across our organization, their leadership, expertise, and dedication drive innovation, elevate quality, and inspire the next generation. As we celebrate International Women's Day, we honor their contributions and commitment to excellence—today and every day. Nicole M., Christine Feaster, Katayoun Meyer, Adriana Kosan, Allison Overton, Beth Usrey, EMBA, Carleigh S., Elizabeth Thomae, Jennifer Fry, Kelly Lynch, Leslie Prince Rudolph, Kimi Broderick, Michelle Black, MBA, Wei Le Learn more about Women in Pharma: https://lnkd.in/ewxwpWfE Visit QxP: https://lnkd.in/eudjgJDQ Visit Virtuosi: https://lnkd.in/eAntv3AH #InternationalWomensDay #WomenLeaders #Pharma #Biotech #QualityAssurance #Training

Are you a pharmaceutical/biologics company looking to onshore manufacturing to the U.S.? QxP knows how to deliver cost effective, efficient, and compliant GMP manufacturing solutions. ? Let QxP help you create your onshoring strategy; develop a comprehensive implementation roadmap; and provide end-to-end support for successful execution.?? ? QxP?- Your Onshoring Partner! Contact Leslie Prince Rudolph at [email protected] to start the conversation. #pharma #biopharma #biotech #qualityassurance #gmp

ANOTHER OUTSTANDING USP LEARNING SESSION Pharmaceutical microbiology, aseptic processing, and sterility assurance require precision and expertise—and continuous learning is key. Join Vanessa Figueroa, Owner, Chief Executive Microbiologist of VVF Science and Executive Director of Microbiology and Sterility Assurance at QxP, for US Pharmacopeia's Sterilization and Sterility Assurance (CM-1229-01) course on March 6, 2025. This session will provide a thorough review of key requirements and industry expectations, with plenty of opportunity for discussion. Find the registration link in Vanessa’s comments or email [email protected] for details. #pharma #biopharma #biotech #qualityassurance #training

2 DAYS LEFT – REGISTER NOW BEFORE IT'S TOO LATE! In just 2 days, join us for USP Science & Research's Introduction to Rapid Microbiological Methods course, happening live on February 27, 2025, from 8:30 a.m. to 12:30 p.m. EST. This blended learning program will provide a thorough understanding of the latest advancements in Rapid Microbiological Methods (RMMs), focusing on cutting-edge technologies and techniques used in the pharmaceutical industry. You’ll learn about the key differences between growth-based and non-growth-based methods, explore technologies used in the detection of contamination in short-life products, and gain valuable insights into the validation and implementation of these methods. The course covers critical USP-NF General Chapters, including: USP <72>: Respiration-Based Microbiological Methods USP <73>: ATP Bioluminescence-Based Microbiological Methods USP <1071>: Rapid Microbiological Methods, Risk-Based Approach Additionally, Virtuosi?, powered by Quality Executive Partners (QxP?), will provide two self-paced video modules on Sterility Testing and Bacterial Endotoxin Testing, covering the materials, methods, and tools used for implementation, as well as how to interpret results and address endotoxin concerns. Don’t miss out on this opportunity to learn from industry experts: Huiping Tu, Ph.D., Senior Principal Scientist, USP Tyler DeWitt, Ph.D., Technical Consultant, QxP Vanessa Figueroa, Executive Director of Microbiology, QxP Register now to secure your spot: https://lnkd.in/gyHPSPtJ #pharma #biopharma #biotech #qualityassurance #training

ONLY 3 DAYS LEFT TO REGISTER! The Introduction to Rapid Microbiological Methods course, hosted by USP Science & Research, is just around the corner! In 3 days, you can join the blended learning program webcast on February 27, 2025, from 8:30 a.m. to 12:30 p.m. EST. In addition to exploring RMM, this course features two self-paced modules on Sterility Testing and Bacterial Endotoxin Testing, provided by Virtuosi?, powered by Quality Executive Partners, Inc. (QxP?). Don’t miss out on this opportunity to gain critical insights from: Huiping Tu, Ph.D., Senior Principal Scientist, USP Tyler DeWitt, Ph.D., Technical Consultant, QxP Vanessa Figueroa, Executive Director of Microbiology, QxP Register now before it's too late: https://lnkd.in/gyHPSPtJ #pharma #biopharma #biotech #qualityassurance #training

ONLY ONE WEEK LEFT! REGISTER NOW FOR THE FEBRUARY 27 WEBCAST Time is running out! There’s just one week left to register for USP Science & Research's Introduction to Rapid Microbiological Methods course on February 27, 2025 from 8:30 a.m. to 12:30 p.m. EST. Don't miss out on this opportunity to learn from leading experts in microbiology and explore the latest advancements in Rapid Microbiological Methods (RMM). Plus, gain access to exclusive Virtuosi? modules on Sterility Testing and Bacterial Endotoxin Testing, featuring industry experts, Vanessa Figueroa and Tyler DeWitt, Ph.D.. Read the full post and register today! Huiping Tu, Ph.D. #pharma #biopharma #biotech #qualityassurance #training

PATENT CLIFF OPPORTUNITY The patent cliff isn’t just a challenge—it’s a major opportunity for companies in the generic and biosimilar space. As blockbuster drugs lose exclusivity, the race is on to develop and commercialize alternatives that ensure continued patient access while maintaining the highest quality standards. At QxP, we specialize in guiding companies through this transition, helping the next generic/biosimilar company accelerate development, navigate regulatory pathways, and uphold the quality expectations that define industry leaders. This is what we do—and we’d be honored to support organizations stepping into this space. Check out Joanna Sadowska, PhD, EMBA insightful post on upcoming expirations. If you’re preparing for what’s ahead, let’s talk. #pharma #biopharma #biotech #qualityassurance #biosimilars

DON'T MISS THE EARLY BIRD PRICE - REGISTER NOW! The early bird price for USP Science & Research's Introduction to Rapid Microbiological Methods course is just US$380, but it ends on February 14—after that, the price goes up to US$475. Don’t wait to secure your spot at a discounted rate! This course offers invaluable insights into the latest advancements in microbiological practices and features exclusive Virtuosi? content on Sterility Testing and Bacterial Endotoxin Testing. Read the full post below for more details and to register today! Huiping Tu, Ph.D. Vanessa Figueroa Tyler DeWitt, Ph.D. #pharma #biopharma #biotech #qualityassurance #training