Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 20th Apr'24 to 30th Apr'24
Quality System Management
- Review of Quality Management Systems (QMS)
- Definition
- Challenges without a QMS
- Elements of a successful QMS
- Launching QMS in your firm
- Types of Quality Management Systems
- Paper based system
- Benefits vs. Roadblocks
- Computer-based Systems
- Benefits vs. Roadblocks
- Sustaining Compliance with QMS
- Support for CAPA systems
- Comprehensive Auditing
- Training
- Document Management
- Investigations
- Product Supply
- Change controls
Overview of the webinar
In many Life Sciences companies, “quality” becomes a “buzz” word. In an industry which is one of the most regulated in the world, quality should come first when a company wants to be productive. If designed properly, quality management systems can help a company achieve its compliance goals and its business goals. With regulations from FDA, EU and others becoming more and more stringent, companies must optimize resources to effectively achieve their quality goals and find their optimal balance between cost and risk.
Who should attend?
- Pharmaceutical professionals involved in the manufacture of products
- All levels of Management
- Quality professionals
Why should you attend?
This webinar will provide comprehensive information pertaining to how to set up an effective Quality Management System at your firm. Types of quality management systems will be discussed such as the differences and benefits of paper-based systems and computer based systems. In addition, each element of the quality system will be discussed in detail and how each relates to the other.
Faculty - Miss.Danielle Delucy
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 establish more robust quality systems so that the company can succeed.