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Regulatory Compliance Associates®
United States
เข้าร่วมเมื่อ 29 ก.ค. 2016
Regulatory Compliance Associates® (RCA) brings solutions to life science companies facing compliance, regulatory, quality assurance, R&D, and operational challenges. We offer top-tier strategic planning, mid-level project management, and hands-on support to provide customized action plans to meet our clients’ needs, on time and on budget.
Founded in 2000
Headquartered in Wisconsin, USA
Expertise backed by over 500 industry subject matter experts
Acquired by Sotera Health in 2021
Sotera Health Company, along with its three best-in-class businesses - Sterigenics®, Nordion®, and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
Founded in 2000
Headquartered in Wisconsin, USA
Expertise backed by over 500 industry subject matter experts
Acquired by Sotera Health in 2021
Sotera Health Company, along with its three best-in-class businesses - Sterigenics®, Nordion®, and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
New FDA draft guidance for Chemical Analysis
In this episode of RCA Radio, host Brandon Miller is joined by Nelson Labs Director of E&L Raymond Colton as well as board certified toxicologist Dr. Sarah Campbell also from Nelson Labs to discuss the recent draft FDA GUIDANCE DOCUMENT: Chemical Analysis for Biocompatibility Assessment of Medical Devices.
Listen in as we cover why this guidance why is important, the potential impacts of this guidance to device manufactures, and some best practices Nelson Labs testing facilities are already implementing to insure a smooth transition once this is published. We discuss things like changes to current chemical characterization approaches as possible leeway that could be given depending on the product.
Listen in as we cover why this guidance why is important, the potential impacts of this guidance to device manufactures, and some best practices Nelson Labs testing facilities are already implementing to insure a smooth transition once this is published. We discuss things like changes to current chemical characterization approaches as possible leeway that could be given depending on the product.
มุมมอง: 45
วีดีโอ
How QMS Impacts Quality Maturity
มุมมอง 955 หลายเดือนก่อน
Watch this webinar where Susan Schniepp explores various strategies behind quality maturity. You’ll learn about regulation changes and how each can impact your team’s success. A real time audience discussion closes the session and will challenge your thinking about audit scenarios. About RCA's Pharmaceutical Consulting Services Regulatory Compliance Associates (RCA) has helped thousands of phar...
Building a Culture of Quality from the Top Down
มุมมอง 400ปีที่แล้ว
Regulatory Compliance Associates Executive Head of Pharmaceuticals, Steven J. Lynn M.S., had the honor of being the FDAnews GMP Quality Management vSummit 2023 Summit Chairperson. This annual summit consisted of the top industry experts on developing a world-class QMS that uses the most up-to-date good manufacturing practices. During the summit RCA's Distinguished Fellow and 2023 Board of Direc...
Global Regulatory Standards
มุมมอง 232 หลายเดือนก่อน
In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder (www.rcainc.com/about/our-people/directors/jordan-elder/) , Regulatory Compliance Associates'® (RCA) Regulatory Expert. Kinga Demetriou, an Expert Certifier at BSI (www.bsigroup.com/) , and Nathan Shipley, a Global Certification Manager at BSI to discuss the current trends and challenges with Regulatory Requirements US ...
Introduction to Microbiology and Sterilization
มุมมอง 185ปีที่แล้ว
Form our partners at Sterigenics: Are you looking for foundational knowledge on microbiology as it relates to sterilization services and testing? Watch this on-demand webinar today by Jennifer Gygi, Expert Technical Consultant from Nelson Labs. Learn the basic vocabulary of microbes, how they are characterized, and where they come from. You will then follow those microbes through the testing pr...
Fundamentals of EBeam Sterilization
มุมมอง 623ปีที่แล้ว
From our partners at Sterigenics we bring you this webinar on Ebeam Sterilization: Since the 1950’s the irradiation of medical devices using electron beam (e-beam) sterilization has been a common practice. Decades later, as medical devices and packaging configurations have become more complex, so has the demand for higher power e-beam accelerators. This webinar will cover the fundamentals of e-...
Product Development Within Design Controls
มุมมอง 113ปีที่แล้ว
About RCA® Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges: Life Sciences Pharmaceutical Biologic & Biotechnology Sterile compounding Medical device Lab Testing We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operat...
Microbial Process Design
มุมมอง 105ปีที่แล้ว
Click now to learn from Sue Schniepp, Distinguished Fellow at Regulatory Compliance Associates, as she describes microbial process design and how your team can improve contamination control. About RCA® Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges: Life Sciences Pharmaceutical Biologic & Biotec...
Waterfall Methodology - Design Controls
มุมมอง 324ปีที่แล้ว
Regulatory Compliance Associates® Dr. Stephen Coulter explain how design controls and risk management play an intricate role in the waterfall methodology. The waterfall methodology incorporates the usage of FDA design controls into the medical device design process. It serves as a primary connection between quality system requirements (QSR) and current good manufacturing practices (CGMP). Conce...
Developing a Contamination Control Strategy
มุมมอง 1.3Kปีที่แล้ว
Learn more about contamination control strategies (CCS), how to identify and assess risks, prepare mitigation pathways, and define preventative actions associated with contamination in sterile product manufacturing. Key Learn Objectives: - Learn about elements for developing a containment control strategy. - Know what to expect from the technical report. - Understand practical considerations fo...
Risk Management and Design Control
มุมมอง 364ปีที่แล้ว
Do you understand how risk management strategy impacts design controls? Join Dr. Steven Coulter as he presents an in-depth overview of the Waterfall design model and addresses the question, Are Risk Management and Design Controls two different processes? You’ll learn more about incorporating risk management strategies into user needs and design inputs, as well as how validating both will accele...
Preparing a Device Master Record (DMR)
มุมมอง 872ปีที่แล้ว
Anything worth doing, is worth doing right! Design Transfer helps manufacturers to reduce business risks. It ensures the company produces the right product with the right process and at the right price. The Device Master Record is the tool to ensure the right data has been provided for consistent and reliable production. About RCA: Regulatory Compliance Associates® (RCA) provides pharmaceutical...
Technical Program Management
มุมมอง 352 หลายเดือนก่อน
In this episode of RCA Radio, host Brandon Miller is joined by Eric Januszewski, Senior Director of Client Relations for US and Europe, at Regulatory Compliance Associates® (RCA) to talk about outsourced technical program management and the increased demand caused by the shortage of qualified subject matter experts. Listen in as Eric goes over what outsourced program management is, the benefits...
2023 Industry Outlook - Pharmaceutical
มุมมอง 1172 หลายเดือนก่อน
In this episode of RCA Radio, host Brandon Miller, Steve Lynn (www.rcainc.com/about/our-people/executive-leadership-team/steven-j-lynn-ms/) , and Susan Schniepp (www.rcainc.com/about/our-people/executive-leadership-team/susan-schniepp/) explore what is happening in the Pharmaceutical industry in 2023 and provide you with insight on how to prepare yourself for these upcoming initiatives. Steve i...
FDANews: Dealing with Real-Life Quality Scenarios
มุมมอง 2222 ปีที่แล้ว
1st Annual Quality Management vSummit: Optimizing Your Quality Management Program to be FDA-Compliant. Session Summary: Learn more about critical quality decision-making with these three realistic scenarios companies can face. RCA Speaker: Steven Lynn, MS, RCA's Executive Pharmaceutical Consultant, has more than 20 years of quality and regulatory compliance-related experience in the pharmaceuti...
FDANews: Quality Metrics: Essential to Quality
มุมมอง 1.5K2 ปีที่แล้ว
FDANews: Quality Metrics: Essential to Quality
FDANews: CDRH's Quality Management Plan
มุมมอง 2292 ปีที่แล้ว
FDANews: CDRH's Quality Management Plan
Optimize your Quality System for Software as a Medical Device (SaMD)
มุมมอง 6832 ปีที่แล้ว
Optimize your Quality System for Software as a Medical Device (SaMD)
The Road to Market Authorization for Sterile Medical Devices within the EU
มุมมอง 2772 ปีที่แล้ว
The Road to Market Authorization for Sterile Medical Devices within the EU
FDA Medical Device Inspections in the Post pandemic World
มุมมอง 4582 ปีที่แล้ว
FDA Medical Device Inspections in the Post pandemic World
Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
มุมมอง 1.5K2 ปีที่แล้ว
Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
2022 Industry Outlook - Pharmaceutical
มุมมอง 292 หลายเดือนก่อน
2022 Industry Outlook - Pharmaceutical
Intro to Pre-Clinical Testing and Biocompatibility
มุมมอง 192 หลายเดือนก่อน
Intro to Pre-Clinical Testing and Biocompatibility
2022 Industry Outlook - Medical Device
มุมมอง 812 หลายเดือนก่อน
2022 Industry Outlook - Medical Device
Past, Present, and Future of Quality Culture
มุมมอง 8023 ปีที่แล้ว
Past, Present, and Future of Quality Culture
Good afternoon. Such an interesting presentation. Is there a possibility to obtain a copy of the slides for pure educational purpose ?
Inspiring and so full of love. Want more views? -> "Promosm".
Thanks you alot
❗ 𝓅𝓇o𝓂o𝓈𝓂
How to Build Resilient & Risk Free Supply Chain th-cam.com/video/Gu33FJl35bM/w-d-xo.html
A very well detailed conversation.