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DVD - Managing Quality Systems


Boston Scientific is the largest manufacturer of medical devices in the world. They currently have 26 global manufacturing, distribution and technology centers. They deliver more than 13,000 products in over 45 countries. In this DVD, John Daley, VP Quality Distribution & Supply Chain gives viewers an inside look at how Boston Scientific’s rapid growth by company acquisition strategy was a key factor in leading the FDA to take multiple regulatory actions against the company, including 483s and Warning Letters.


These regulatory actions spurred Boston Scientific’s management to change how their vast Quality Systems were operated and managed both at the plant and corporate levels. This DVD also discusses the following critical areas of compliance, including:

➢How the Company Currently Prioritizes Quality System Initiatives

➢How Boston Scientific Monitors the Quality System at the Corporate Level

➢How they Utilize Management Review & Supply Chain Review


Note: This item included in a CONTENT package only - Click Here to review Effectively Managing Quality Systems CONTENT Package


 

➢GMP CONTENT Packages include: SOPs, PPTs, templates, regulations, inspections, change control, CAPA, Computer, Part 11, and much more- click here to view all GMP CONTENT Packages

➢GCP CONTENT Packages include: SOPs, PPTs, templates, clinical monitoring, informed consent, adverse events, scientific misconduct and more - click here to view all GCP CONTENT Packages

➢GLP CONTENT Packages include: SOPs, PPTs, quality questionnaire, templates, deviations, inspections, regulations and more - click here to view all GLP CONTENT Packages


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