How to use electronic systems for document control, WITHOUT 21 CFR part 11 implications.
Why You Should Attend:
A document control system is required for compliance with federal (FDA) and international (ISO) compliance. Implementation, performance, and maintenance of a compliant document control system can be time-consuming and costly. Even the simplest of changes often 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. This webinar reviews FDA and ISO requirements for document control. This webinar also offers a cost-effective, time-saving alternative to a typical document control system. Discussion will be on How to use electronic systems for document control, WITHOUT 21 CFR part 11 implications.
Areas Covered in the Seminar:
- History of document control.
- FDA requirements for document control.
- ISO 13485 requirements for document control.
- Elements/practices of a typical document control system.
- Elements/practices of a streamlined document control system.
- How to use electronic systems for document control, WITHOUT 21 CFR part 11 implications.
Who Will Benefit:
This webinar will provide valuable assistance to all companies who want to implement a streamlined document control system. The employees who will benefit include:
- Top management
- Regulatory Management
- Quality Management
- Documentation Control personnel
- Consultants
- Other personnel involved in development and implementation of the document control system
Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
