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It is well known that document control is a critical requirement for FDA-regulated companies. However, document control can be a time- and paper-consuming process, in which even the simplest of changes requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. The best document control systems are those that are fast and effective. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process - Many companies can spend MUCH LESS preparing MANY FEWER documents, and still be in compliance with the regulations; is yours one of these?
Areas Covered in the Session:
QSR and ISO 13485 requirements for document control
Description of typical document control system in use
Streamlined document control process
Paper-free document review
Immediate document distribution
- Q/A Session with the Expert to ask your question
- PDF print only copy of PowerPoint slides
- 60 Minutes Live Presentation
Who will benefit: The designations
This webinar will provide valuable assistance to all regulated companies that are interested in learning about the requirements for a document control system, and spending less time on its implementation and performance. The employees who will benefit include:
Document Control Management
Document Control Clerks
Quality system auditors
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 oversees supplier management, CAPA, and document control. 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.