Speaker Profile


Deb Simpson

Quality Manager, Vention Medical

Deb Simpson has led development, implementation, and management of Quality Management Systems for regulated industry for more than 30 years. She has been involved with a variety of products and industry areas, including: 1. Medical Device, Pharmaceutical, Biologics, Tissue Banking, Medical electronics, Drug delivery devices, custom surgical convenience kits, Vet Med products. Combination products: Drug/Device/Biologics; Drug delivery devices. 2. Orthopedic implants, electronic monitors, medical textiles, respiratory inhalation systems; tracheostomy tubes, voice restoration products. surgical instruments, renal dialysis products; human and animal tissue processing and related products.

Deb is an experienced Quality System auditor and has served as Management Representative for several companies, including: Baxter Healthcare, Stinger Medical, Wright Medical, Regeneration Technologies, Bespak, Inc.

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  • Recorded
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  • $190.00
Change Control,CAPA,Document Control, and Electronic Systems

Change control, is by its nature and scope, is the most significant QMS intersection. Yet there are no specific QMS regulations that clearly define all areas to be considered. Rather, the scope is defined by the products, processes, and related regulations. Document control is an element of change control, as well as one of the feeder systems, and is also an outcome of change control. In process terms, document control can be an input, a process step and an output of the change control process. Document control is a foundational element of the QMS and provides the structure and support for many other elements, including change control and CAPA.

  • Recorded
  • View Anytime
  • $390.00
Change Control,CAPA,Document Control, and Electronic Systems

Change control, is by its nature and scope, is the most significant QMS intersection. Yet there are no specific QMS regulations that clearly define all areas to be considered. Rather, the scope is defined by the products, processes, and related regulations. Document control is an element of change control, as well as one of the feeder systems, and is also an outcome of change control. In process terms, document control can be an input, a process step and an output of the change control process. Document control is a foundational element of the QMS and provides the structure and support for many other elements, including change control and CAPA.

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