Marie Dorat

Marie Dorat

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

Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.

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 conducts training courses for both 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 inspections.
  • Validation Master Plan Marie Dorat Compliance Trainings
    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...
  • 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...
  • MDSAP Compliance Trainings
    Inspections are critical to the success of business on several levels. Therefore, being appropriately prepared and management of the inspection process is a critical activity. The consequences if a company does not pass an inspection are time consuming, delayed...
  • The focus of this session is international product registration for IVDs & Medical Devices. Product registrations requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been reduced....
  • US EU Medical Devices Compliance and Regulatory Affairs Charles Paul Compliance Trainings
    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...
  • Auditing 101 Auditing Techniques Internal Auditing Marie Dorat Compliance Trainings
    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...
  • US EU Medical Devices Compliance and Regulatory Affairs Charles Paul Compliance Trainings
    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...
  • The US FDA has published the final regulations for Unique Device Identification (UDI). Manufacturers must start implementation planning. UDI implementation requires understanding of several major steps: Producing compliant device labels, packaging Uploading the appropriate information into the GUIDID Updating...
  • Validation Master Plan Marie Dorat Compliance Trainings
    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...
  • Auditing 101 Auditing Techniques Internal Auditing Marie Dorat Compliance Trainings
    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...
  • Sale! UDI Implementation - What is required ?
    The US FDA has published the final regulations for Unique Device Identification (UDI). Manufacturers must start implementation planning. UDI implementation requires understanding of several major steps: Producing compliant device labels, packaging Uploading the appropriate information into the GUIDID Updating...
  • Developing a Compliant QMS for FDA (QSR and ISO 13485/9001)
    This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA QS requirements. Medical device companies are utilizing ISO standards to build their business management systems because of their...
  • International product registrations - Lessons Learned
    The focus of this session is international product registration for IVDs & Medical Devices. Product registrations requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been reduced....
  • 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...
  • Clinical Trial Monitoring - What is Required?
    This course clarifies the role of the Clinical Research Monitor and explains their responsibilities under the GCP guidelines. This course will also discuss interactions with others in key roles as part of the clinical trial as well as exploring...
  • FDA vs EU Inspections - Differences and How to Get Prepared
    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...
  • This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality System requirements. Medical device companies are utilizing ISO standards to build their business management systems because of...
  • Placeholder
    Description: The focus of this session is international product registration for IVDs & Medical Devices. Product registrations requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been...
  • Placeholder
    Description: This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality System requirements. Medical device companies are utilizing ISO standards to build their business management systems because...
  • Placeholder
    Description: This course 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. This course will provide guidance on best...
  • FDA vs EU Inspections - Differences and How to Get Prepared
    Description: 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...
  • ICH-FDA Good Clinical Practice - Managing Clinical Trials
    Description: 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...
  • Internal Auditing - What you need to know
    Description: This course will provide guidance on best practices for conducting internal audits. You will learn how to conduct an internal audit. We will discuss the internal audit process from A to Z. We will explore strategies for dealing...
  • Developing a Validation Master Plan
    Description: This course 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. This course will provide guidance on best...
  • Developing a Quality Management System
    Description: This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality System requirements. Medical device companies are utilizing ISO standards to build their business management systems because...
  • Sale! International product registrations -  Lessons Learned?
    Description: The focus of this session is international product registration for IVDs & Medical Devices. Product registrations requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been...
  • Internal Auditing - What you need to know
    Description: This course will provide guidance on best practices for conducting internal audits. You will learn how to conduct an internal audit. We will discuss the internal audit process from A to Z. We will explore strategies for dealing...
  • ICH-FDA Good Clinical Practice - Managing Clinical Trials
    Description: 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...
  • Sale! FDA vs EU Inspections - Differences and How to Get Prepared
    Description: 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...