Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
Instructor:
Jeff Kasoff
Product ID: 700254
- Duration: 60 Min
Why Should You Attend:
Document control can be a time- and paper-consuming process. 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. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.
Areas Covered in the Webinar:
- 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.
- Paper-free document management system.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that are interested in spending less time on document implementation. The employees who will benefit include:
- Executive Management
- Document Control Management
- Document Control Clerks
- Consultants
- Quality system auditors
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of site quality system compliance, including the CAPA program, and has established and overseen document control systems. Jeff is also the liaison with FDA and notified body auditors. In his previous position, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. 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, and his Quality Management Certification in 2013.
More Training By Experts
- Supplier Management: Challenges and Opportunities
- The FDA Inspection Process: From SOP to 483
- Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
- Training Requirements and Practices to Assure QSR and ISO Compliance
- Complaint Handling and Management: From Receipt to Trending
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
