Developing a Quality Management System – Where Do I Begin?
Duration : 75 Minutes
Marie Dorat,
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years experience, in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; Read more
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 benefits and as a necessary step to market their products globally.
During this
Course Objectives:
This course will provide guidance on best practices for developing a compliant QMS. We will explore strategies for dealing with common documentation and compliance issues. The course also summarizes the essential documentation requirements and gives an introduction to the key elements for implementation of a compliant system.
Course Outline:
By the end of this course, participants will have
• Understand the Quality Management Principles
• Discuss the benefits of an effective QMS
• Review the Quality Essentials
• Procedure Development
o Understand the required documentation:
o Quality Manual
o Policies
o Procedures
o Work Instructions
• Identifying Exempt sections & how to document
• Auditing your QMS – Looking for gaps
• Managing and maintaining your QMS
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance Professionals
• Compliance Professionals
• ISO 13485/9001 Implementation Team Member
• Senior Management
• Regulatory Affairs Professionals
• Project Managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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