“Laurie carried out a complete quality system audit for us ahead of an accreditation audit. She was very professional and well organized ahead of, during and after the audit. This, coupled with her knowledge of the regulation and her depth of experience led to identifying several important areas for improvement which will benefit us going forward.”
About
Provide Consulting Services for Medical Device and Combination Product Regulatory and QMS…
Services
Activity
-
We have issued a draft guidance to help industry review analytical chemistry studies for assessing the biocompatibility of medical devices for…
We have issued a draft guidance to help industry review analytical chemistry studies for assessing the biocompatibility of medical devices for…
Liked by Laurie Brager Auerbach
-
Fuel your tech company’s growth by mastering cash flow management. Unlock the strategies that keep your business moving forward—click to explore how…
Fuel your tech company’s growth by mastering cash flow management. Unlock the strategies that keep your business moving forward—click to explore how…
Liked by Laurie Brager Auerbach
-
Our friends at Pathway for Patient Health invite you to join them for a one-hour Town Hall meeting, as Marla Phillips, Ph.D interviews FDA's Dr. Jeff…
Our friends at Pathway for Patient Health invite you to join them for a one-hour Town Hall meeting, as Marla Phillips, Ph.D interviews FDA's Dr. Jeff…
Liked by Laurie Brager Auerbach
Experience
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Education
Licenses & Certifications
Organizations
-
ISPE Combination Products Community of Practice (CoP)
Vice Chair
- Present -
AAMI
-
- Present -
RAPS
-
- Present -
TOPRA
-
Recommendations received
14 people have recommended Laurie
Join now to viewMore activity by Laurie
-
Who is responsible for design controls? In this segment from Drug Delivery Leader Live, Executive Editor Fran DeGrazio asks consultants Laurie Brager…
Who is responsible for design controls? In this segment from Drug Delivery Leader Live, Executive Editor Fran DeGrazio asks consultants Laurie Brager…
Liked by Laurie Brager Auerbach
Other similar profiles
Explore more posts
-
Rook Quality Systems
Preparing for an FDA inspection or ISO audit can be stressful, whether it's your first time or you're a seasoned pro. The RookQS team understands the complexities of audit preparation and we're here to help. Check out our key tips to ace your next audit, and remember, if you need further assistance, Look to Rook! #FDAInspections #ISOAudit #Compliance
-
COBBLESTONE (previously CfPA - The Center for Professional Advancement)
Introduction to CAPA Management - A Critical Quality System Requirement Register now for this vital training: https://hubs.ly/Q02FV1m90 🔍 Recent FDA form 483s and warning letters emphasize the importance of robust CAPA (Corrective Action and Preventative Action) programs in Quality Systems. 📝 Our upcoming 60-min accredited training will cover: - Writing effective CAPAs from initiation to follow-up - Building & strengthening CAPA Management for proactive Quality Management Systems - Analyzing key case examples for continuous improvement 💡 Stay ahead of industry trends & join us in mastering CAPA Management to prevent product recalls, complaints, & further FDA actions. Attend LIVE to engage with expert Laura Jeannel and other attendees - ask questions & get answers! DATE: August 1, 2024 from 11 am EDT - 12 pm EDT Can't make it live? On-demand option is available #CAPA #qualitysystems #FDA #483s #FDAwarningletters #quality #cobblestone
-
BSI Medical Devices
By 26 May 2024 manufacturers transitioning legacy devices to the MDR have to put in place an MDR compliant QMS and formally apply to a Notified Body. Be aware that at the time of application, you need to provide the documentation required as per the applicable Annex (e.g., Annex IX, clause 2.1). #BSI #MedicalDevices #MDRTransition
-
John Clerkin MCIPD
By 26 May 2024 manufacturers transitioning legacy devices to the MDR have to put in place an MDR compliant QMS and formally apply to a Notified Body. Be aware that at the time of application, you need to provide the documentation required as per the applicable Annex (e.g., Annex IX, clause 2.1). #BSI #MedicalDevices #MDRTransition
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More