Quality System Management Effectiveness
Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices, and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees, and those wishing to improve compliance to establish more robust quality systems so that the company can succeed.
Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient. 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.
It’s the common, centralized culture of quality that many people struggle with. Quality management has a very important role but needs to be “consumable” by multiple operational areas within the organization. So how can organizations create a simple, consumable way to gain broad visibility into Quality management, while making it easy and centralized? This webinar will review the variables needed in order to create a solid Quality Management System.
- What are the components of a proper Quality Management System?
- What it means to build a “culture of quality” that reaches to the whole organization
- How you can effectively collaborate on quality management while keeping it simple
- Cost of quality
- What is Quality Management all about?
- Tools for Continuous Quality Improvement
- Discussion of what to do when major quality problems are found
Who Should Attend
- QA staff and management
- Compliance Personnel
- Regulatory Affairs staff and management