Marie Dorat
CEO of IPRF, LLC
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution.

Ms. Dorat has 13 years’ experience in quality assurance and regulatory affairs in the pharmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA positions. She has worked for several companies including Pfizer, and Alere She has lectured at conferences and provides on-site training courses on QA and GxP issues.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months. She provides training courses both for public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspection- How to Prepare,.
Upcoming Webinar
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Recorded Webinar
FDA vs EU Inspections - Getting Prepared and What are Differences
This training is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
Recorded Session Get life time access for one participant with download option!

Master Validation Plan - A Complete Package
This course will provide guidance on best practices for developing and implementing a good plan detailing responsibilities and deliverables to make validation efficient and consistent. It will provide a step-by-step guidance for medical device companies that need to develop a validation master plan (VMP) for product/equipment transfer, facilities, processes or to develop a company standard.
Recorded Session Get life time access for one participant with download option!

Auditing 101
The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used in auditing.
Recorded Session Get life time access for one participant with download option!

Developing a Validation Master Plan
This webinar will provide all medical device companies with a step by step process on how to develop a validation master plan (VMP) for product/equipment transfer, facilities, or to develop a company standard. It will also provide a detailed insight on the best practices for developing and implementing a good plan detailing responsibilities, and deliverables to make validation efficient, and consistent.
Recorded Session Get life time access for one participant with download option!

Clinical Trial Monitoring - GCP Expectations
This course clarifies the role of the Clinical Research Monitor and explains their responsibilities under the FDA-ICH GCP guidelines. This course will also discuss interactions with others in key roles as part of the clinical trial as well as exploring some aspects of clinical trial monitoring.
Recorded Session Get life time access for one participant with download option!

FDA vs EU Inspections – Getting Prepared and What are Differences
This training is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
Recorded Session Get life time access for one participant with download option!

ICH-FDA Good Clinical Practice – Managing Clinical Trials
This course provides an overview of the critical elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to Sponsor Responsibilities and Quality Management of the clinical trial.
Recorded Session Get life time access for one participant with download option!

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