Live Webinar Document Control for Start-ups: Cost-Efficient and Compliant

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate by the speaker ,Q/A and 60 mins Live Webinar

"Hear By Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management"

Document control can be a time- and paper-consuming process. To your start-up, time is a valuable commodity. So is money.

Description

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. Your start-up 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. And the best thing... it utilizes software you already have.

Areas Covered

•    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 resource-challenged FDA-regulated companies, since Document Control is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields no matter how small how you are! The employees who will benefit include:
•    Executive Management
•    Document Control Management
•    Document Control Clerks
•    Consultants
•    Quality system auditors

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

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