Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Auditors look for standardization and standardizing programs can benefit quality, compliance, and regulatory professionals. Ensuring consistent methods are implemented across your business reduces risk, strengthens your processes, and fosters robust, repeatable quality.
Targeted audits and inspections are your secret weapon for driving a standardization program that actually works.
Attend this free webcast to learn how targeted audits and inspections can be your secret weapons for driving an effective standardization program. Presenters will share top tips and tactics, mistakes to avoid, and detailed guidance to help you start working towards stronger, more standardized business operations.
Upon completion of this program, you will know:
Director Of Quality, Qualio
Kelly Stanton is the director of quality at Qualio, helping customers and the company adhere to the evolving regulatory landscape. She serves as an advisor to more than 20 medical device and pharmaceutical companies and leads a team of talented industry-experienced quality professionals, who work daily with companies in regulated industries. Stanton brings more than 20 years of experience in both the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator and user of many different eQMS tools on the market, she has built several quality systems.
Founder & CEO, Rimsys Regulatory Management Software
James Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.
Vice President, Quality & Operations, MWA Consulting, Inc.
Lisa Helmonds is Vice President of Quality Services & Operations, MWA Consulting, Inc. She has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical, biotechnology and medical device industries. She has extensive GxP knowledge, has worked with several startups and large companies to implement or improve quality systems and procedures, and understands the challenges facing the industry.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help
For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.