Setting up a Quality Management System (QMS)
Instructor:
Elizabeth E Bodi
Product ID: 701126
- Duration: 60 Min
Regardless of the organization, its size or whether it in the private or public section, clinical research companies often forget to think about a set of standardized requirements for a quality management system (QMS). A good QMS consists of standards and guidelines relating to their everyday business practices including but not limited to policies/procedures (or a Quality Manual), SOPs, and Work Instructions. So how do we make sure the quality framework for a given organization is solid, comprehensive and does not fall through the cracks?
Areas Covered in the seminar:
- What is a QMS.
- Principles
- Resources
- Getting started (QM, SOP on SOPs)
- Record Keeping/Retention
- Training
- Continuous improvement; like metrics and best practices -- plan, do, check, act
Who will benefit:
This webinar will provide valuable assistance to all regulated companies with a strong focus on quality. The employees who will benefit include:
- Personnel writing and reviewing Standard Operating Procedures (SOPs) and Work Instructions
- Personnel writing and reviewing Quality Manuals
- QA managers and personnel
- Information Technology managers and personnel
- Quality system auditors
Elizabeth E. Bodi, is an Associate at Halloran Consulting Group, a privately held firm whose vision is to conduct clinical trials with biotechnology, pharmaceutical and medical device development clients using smarter approaches to clinical trial management. With over 17 years in the clinical research industry, Liz’s experience ranges from monitoring to clinical project management, clinical training management, and clinical quality assurance. Liz has provided training on clinical research with a focus on clinical operations, SOP development and training delivery for quality management systems.
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