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Validity : 14th Apr'24 to 24th Apr'24
Selecting an e-QMS – Things to Consider
Before the Search
- Changing the Culture
- Identify Individual/Departmental roles
Plan the Implementation
- For each area, work through what is required – scope; promotion; training; participation; documentation; review and revision
- Identify who will take the lead in each part
- Use project management principles to identify the activities, timescale and resources
Begin the Search: Critical Elements to Consider
- Adaptability
- Web Based versus Server Based
- Analyzing Data - Reporting
- Taking Quality to the Enterprise - Scalability Matters
- Tying System Together through Integration
- Know Your Audience - End User Acceptance
- Cyber Security
Implementation and Deployment
- Look and Feel - Making the System your own
Overview of the webinar
This course will cover considerations and requirements when selecting an Electronic Quality Management System (e-QMS). Due to the current climate of regulatory compliance, there is a real need for companies to select the appropriate electronic quality management systems (e-QMS).
Finding the right solution for your company can be a confusing and stressful activity. Often, organizations will select a system that allows some of their workflows to execute seamlessly but still didn’t get everything they wanted.
Who should attend?
- Regulatory Affairs
- Regulatory Compliance
- Quality Assurance
- IT
- Document Control
- Those who have responsibility for selecting and implementing an e-Quality Management System, as well as those that have key collateral roles in reviewing and/or approving a company-wide implementation of an e-QMS
Why should you attend?
How will this benefit your company? All organizations have management procedures and instructions for creating and delivering their products to customers. Most have evolved over a period of time, and are generally adequate. However poor management systems can lead to wasteful processes, poor products and services, and dissatisfied customers.
Faculty - Ms.Marie Dorat
Marie Dorat, CQA, CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 15 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 process the necessary documents for international product distribution. She is also Managing Partner at iComplyRegs, LLC which provides the most current FDA/EU/ROW regulatory requirements updates as well as experienced RA/QA Consultants