11/29/2197 - Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner

Thu, 17 Sep 1925 00:03:28 +0000

Overview: 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. 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.

Areas Covered in the Session:

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:

Regulatory Management
Quality Assurance Professionals
Consultants
Sales/Marketing Management
Senior and mid-level Management
Quality System Auditors

Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is oversight of the document control system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue.

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10/30/2016 - Introducing a Mobile-First Approach to Building Your Next App

Sun, 30 Oct 2016 16:00:00 +0000

Wednesday, October 30, 2013

Presented by: Carlos Andreu, Raj Balasubramanian

Duration: Approximately 60 minutes.

Cost: Free

The webcast is based on an upcoming 'Mobile First' book that Raj Balasubramanian and Carlos Andreu are working on with O'Reilly Media. This hands-on webcast will cater to two class of developers - enterprise or backend developers who have dabbled in building web sites but hasn't spent much time on mobile, and the other class is anyone new to mobile app development be it designers or developers.

This webcast will highlight why the mobile first approach is necessary in building your next user facing app and why it's not a hype. Concrete examples will be provided using both mobile web and hybrid technologies to illustrate how you can get started. We will close by covering how the same concepts relate in the native world for education and awareness. We also touch upon enterprise concerns like integration and security with legacy systems in typical mid to large companies.

About Raj Balasubramanian

Raj Balasubramanian is a Product Architect for IBM Software Group working on the IBM Mobile Foundation. He leads the client-services interaction for the IBM Worklight and IBM Mobile Foundation. Prior to his development role, he led customer engagements delivering application and infrastructure related projects around SOA, BPM, Web 2.0 and Portal technologies. His interests range from anything technical to history, math and physics. He is currently pursuing his PhD at University of Texas at Austin. You can read about his past technical and personal escapades on his personal blog Gurukulam at balasubramanians.com/blog.

About Carlos Andreu

Carlos Andreu is a Software Engineer at IBM in Austin, TX. He currently works with a mobile framework called IBM Worklight that aims to provide developers a simple way to write multi-platform hybrid mobile applications. Carlos holds a Bachelor of Science in Computer Engineering from the University of Puerto Rico.

WebinarListings

11/29/2197 - Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner

10/30/2016 - Introducing a Mobile-First Approach to Building Your Next App

About Raj Balasubramanian

About Carlos Andreu