RAPS pre-approved webinar on “21 CFR Part 11: Auditing for Part 11 Compliance”
11/23/2012

A RAPS pre-approved webinar on the topic, “21 CFR Part 11: Auditing for Part 11 Compliance” is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on December 4.

Online PR News – 23-November-2012 – Wilmington – Description:
Electronic signatures are going to be the documents of the future. This is for two vital reasons: The need for the global economy to be super quick, and an equally great need for the world to go green. In this context, software technologies that facilitate the use of these tools can make a huge contribution to both the global climate and the speed at which humans communicate with each other.
21 CFR Part 11 is a regulation that seeks to regulate the technology that relates to electronic signatures and electronic records. It is a regulation that will define the standards for electronic records and electronic signatures, and will become an integral part of the scope of an organization’s internal and external audits. Yet, strangely, most organizations do not know how to prepare and execute such audits.
This webinar will provide a proper understanding of this regulation. It will give participants a clearer understanding of creating and validating electronic records and documents, as well as signatures. It shows organizations ways by which to comply with these regulations for complete and hassle-free audit and verification of these electronic documents. The prime focus of this session is on the difference between regular QMS audits and 21 CFR audits. During the course of this two-hour long discussion, the expert will talk on the following:
o Short and quick overview of the Part 11 regulation
o Detailed description of HOW TO prepare internal and external audits schedules to include Part 11 audits
o How to prepare for a specific audit that includes Part 11 regulation
o Execution of the audits
o Follow up (difference from other quality audits)
o Training requirements; good practices
o Commonly asked questions
o Warning letters examples
o What the future holds when it comes to Part 11
o The focus is on difference between regular QMS audits in audits when Part 11 is in scope of the audit - from auditors
o Regulations
o Training
o Preparation
o Execution
o Follow up and other standpoints
-----------------------------------------------------------------------------------------------------------------
When:December 4, 10:00 AM PDT | 01:00 PM EDT
-----------------------------------------------------------------------------------------------------------------
By whom:
Jasmin NUHIC is a Senior Manager, Manufacturing Engineering at Medtronic, Inc. (Peripheral Therapies) in ZĂĽrich, 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