Jeff Kasoff 2012 - Document Approval, Control, and Distribution: How to Develop a Compliant, Cost Effective System

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

Who will benefit:

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:

Executive Management

Document Control Management

Document Control Clerks

Consultants

Quality system auditors

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