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 lectured at conferences and on training courses on QA and GXP topics.
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. IPRF also assists companies process the necessary documents for international product distribution. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. ISO 13485/9001 Implementation Team Members,
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Identifying Exempt sections & how to document Understand the Quality Management Principles The course also summarizes the essential documentation requirements and gives an introduction to the key elements for implementation of a compliant system. We will explore strategies for dealing with common documentation and compliance issues. This course will provide guidance on best practices for developing a compliant QMS. Medical device companies are utilizing ISO standards to build their business management systems because of their benefits and as a necessary step to market their products globally.ĭuring this webinar we will discuss the documentation process, and implementing a management system to meet the requirements of ISO and QSR and the operational objectives of the company We will discuss ISO Quality Management standards and the FDA QS requirements. This webinar provides an overview of the Quality Management System requirements.
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