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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
Root Cause Investigation for Correction and Preventative Action (CAPA) is a globally renown methodology for investigating technical performance challenges. During this two-day online workshop, participants will be introduced to the methodology and then immersed in practical exercises to leverage the instructor-led case studies.
Root cause methodology to be covered includes problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others that are leveraged to identify:
Attendees will be provided resources including a training manual, investigation roadmap, and set of electronic templates to reference. This set of tools will be useful in guiding participants through the methodology to establish the basis for documentation. Participants will work in small groups to apply the methodology and further develop their skills using real-life case studies.
12 December 2020 – 15 January 2021: $800 Member | $900 Nonmember 16 January 2021 – 15 February 2021: $900 Member | $1000 Nonmember
Tuesday, 16 February (9:00am–5:00pm)
Wednesday, 17 February (9:00am-5:00pm)
Founded in 2003, Weaver Consulting is solely focused on root cause analysis. Comprised of former Vice Presidents and quality/operations consultants Rob and Tom Weaver (Wells Fargo & Company and Baxter Healthcare), they teach a proven, disciplined methodology to achieve optimal results in as little time as possible while simultaneously ensuring robust documentation meeting the stringent requirements highly regulated industries demand. Their premier methodology, Root Cause Investigation for CAPA, is designed for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify technical and systemic root causes, then implement corrective actions to restore performance to previous levels or requirements, and a control plan to monitor and prevent or minimize future recurrence.
Weaver Consulting have been featured speaker’s with: Food and Drug Administration (FDA), American Society of Quality, Regulatory Affairs Professionals Society, Food Safety Consortium, Food Safety Tech, Parenteral Drug Association, Sparta Connection (TrackWise), Medical Device & Manufacturing, Center for Professional Advancement, and Medtech. They’ve been published or interviewed with: American Pharmaceutical Review and Medtech Insight (The Gray Sheet).
Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association, and business professionals. She is on the faculty of George Washington University School of Medicine and Health Sciences, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. She currently teaches CDRH reviewers at the center’s staff college and the investigators at ORA University. Previously, she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.
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. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.
RAPS will send an electronic letter or a certificate of attendance upon request.
Call RAPS Solutions Center at +1 301.770.2920, Ext 200 or email raps@raps.org.