Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society

Events

2021

January 27, 2021     

Upcoming RMRAS Webinar

Remote Auditing - Tips & Techniques
Learn from our panel of experts about their experiences with Remote Auditing.  
  4:00 pm - 5:00 pm

Sponsored by

EVERSANA™ is the leading provider of global services to the life sciences industry. Our integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value. We serve more than 500 organizations, including innovative start-ups and established companies to advance life science solutions for a healthier world.
 

Please join us on January 27, 2021 for a  webinar on Remote Auditing.  Panel members have conducted and hosted several remote audits and will share their experiences and tips with the audience.  We encourage everyone attending to send in questions ahead of time to programs@rmras.org.  There will also be time during the webinar to comment and ask questions.


Our panel consists of four industry professionals are:

Nancy Sauer, Director of Regulatory Affairs, Medtronic Surgical Energy and Safety
Steve Beauchamp, Quality Director, Eversana

Darren Doherty, Director of Quality Assurance, Flagship Biosciences

Justin O'Neal, Quality Assurance Director, Eversana

 

This program is using the Go to Webinar platform.  To register, go to 

https://attendee.gotowebinar.com/register/238292069793172750

 

2020

2020 Quality System Regulation Course

October 30, 2020

Below are the slides presented at the 2020 QSR course.  If you have any questions or need additional information, contact Nan Matthews at programs@rmras.org

 

Opening Slides
Opening slides.pdf
Adobe Acrobat document [231.0 KB]
Management Controls.pdf
Adobe Acrobat document [157.3 KB]
Document and Record.pdf
Adobe Acrobat document [151.2 KB]
Design Controls.pdf
Adobe Acrobat document [454.2 KB]
CAPA.pdf
Adobe Acrobat document [221.8 KB]
Complaints.pdf
Adobe Acrobat document [135.8 KB]
Nonconformance.pdf
Adobe Acrobat document [144.8 KB]
Production and Process Controls.pdf
Adobe Acrobat document [283.7 KB]

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Contact Us

Rocky Mountain Regulatory Affairs Society

 

Phone: +1 (303) .843-6414

E-mail: info@rmras.org

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