2-day In-person Seminar on
DHF, DMR, DHR and TF - Regulatory Documents Explained, and Best Practices for Controlling Them RAPS Approved. Earn 12 RAC Points
Date & Time:
April 26th and April 27th 2012
8 AM PDT to 5 PM PDT
Duration: 2 Days
Instructor: Jeff Kasoff
Price : $1695.00
Register Now
Instructor Profile:
Location: Courtyard by Marriott Philadelphia Downtown
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
(for one participant)
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. ...more
Overview: To be in substantial compliance with FDA and ISO regulations, there are many documents that must be maintained by your firm. From the earliest phases of the design process all the way through manufacturing and distribution, all aspects of your plans and records must be documented. As well known as these requirements are, that’s the extent to which they are fraught with potential deficiencies. Similarly critical to a compliant document maintenance system is a robust document control system. Without a complete document control system, a company will be out of compliance; without an efficient document control system, a company may be out of business! Don't let your company be that company.
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Document Control Personnel R&D Personnel/Management Regulatory Affairs Management Senior Management
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