RAPS pre-approved webinar on "21 CFR Part 11:How to Successfully Prepare for and Host an FDA Inspection"from GlobalCompliancePanel

(prHWY.com) August 24, 2012 - Wilmington, DE -- Description:
21 CFR Part 11 is a regulation that governs the way electronic records and signatures have to be audited and verified. Although drafted keeping the pharma industry in mind; these regulations will eventually cover a swathe of industries in the future. It is important for organizations to adapt electronic records and signatures because the process accelerates the speed of communication and also helps the earth go greener, with lesser reliance on paper records.
Despite the importance of these regulations; most organizations are unaware of how to apply them for their audits. This webinar will give them an understanding of not only how to implement 21 CFR; but also familiarize them with how to deal with an FDA inspection of these records. It will teach them ways by which they need to prepare for an FDA inspection, as well as how to host one. It will cover the following areas:
o Short and quick overview of the Part 11 regulation
o Detailed description of HOW TO prepare for an FDA inspection
o When and Where Part 11 is in scope or the scope of the inspection;
o Detailed description of HOW TO handle the FDA inspection during the inspection itself;
o Some trends when it comes to Part 11 inspections;
o Commonly asked questions; warning letters examples, and what the future holds when it comes to Part 11
-----------------------------------------------------------------------------------------------------------------
When:September 19, 10:00 AM PDT | 01:00 PM EDT
-----------------------------------------------------------------------------------------------------------------
By whom:
Jasmin NUHIC is a Senior Manager, Manufacturing Engineering at Medtronic, Inc. (Peripheral Therapies) in ZÃ¼rich, Switzerland, and is a 21 CFR Part 11 Subject Matter Expert. He is also Adjunct Professor at DeVry University and Keller Graduate School of Management.

As a Quality professional, Jasmin NUHIC has a proven record of leading teams that deliver results with full scope, below budget and ahead of schedule through process optimization, business growth and talent development. During the over 12 years of his professional life in the FDA-related industries; Nuhic has gained vast experience in operations, quality management systems, manufacturing, concurrent engineering, program management and information systems. He has obtained over 25 different certifications in leadership, quality, software validations and related areas.

He has earned positive and verifiable track record in helping organizations implement continuous improvement and cost saving initiatives through the use of lean sigma and six sigma methodologies. He has imparted this expertise through webinars on these topics, which usually have high attendance and have come in for appreciation.
-----------------------------------------------------------------------------------------------------------------
For whom:
The webinar will benefit
o Quality Managers
o Quality Engineers
o Small Business Owners
o Internal and External Auditors
o Management Reps
o FDA Inspectors
o Consultants
----------------------------------------------------------------------------------------------------------------
Duration:120 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

###