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Webinar Description:

Part 11 Compliance Simplified: Easy, Cheap
and Fast Steps to Meet FDA Requirements
Product Id IT1213
IT Compliance
Scheduled On Thursday, July 31, 2014 at 13:00 Hrs
Duration 90 Minutes
Speaker Herman Wong

This webinar will discuss the Part 11 requirements and practical
techniques for evaluation of the current compliance status of a given
organization. You will hear about validation requirements, system security
protocols, rules for building computer networks, adding new components to
network, back-up of data, access control, rules for passwords, and audit
trails. Case studies will be used to highlight common issues and potential

21 CFR Part 11 describes the quality standards required of all computer
systems used in FDA-regulated industry. This regulation provides the basic
framework for computer systems used to generate records and data used
for analysis and presentation. However, for any organization trying to
understand and implement Part 11 requirements, there are only two
options: One, hire expensive consultants and purchase expensive
software, or implement self-created systems and live in constant fear of
findings of non-compliance during FDA audits. we will simplify the
regulatory requirements and add practical tips for quick and easy
verification of compliance with FDA requirements which can be self-
implemented by most organizations with minimum technical expertise.

Area Covered in Session
Part 11 requirements by FDA
Applicable systems per the FDA
Validation of computer systems
Network set-up, maintenance, integrity check and security
Common elements of Part 11 complaint computer systems
Building Part 11 compliant systems bottom-up and top-down.
Back-up and re-creating data
Verifiable audit trails
Electronic signatures and certificates
Best practices for using non-networked computers
Who Will Benefit:
This webinar will provide valuable information to:
FDA-regulated labs, clinical trial sites, manufacturers, and sponsors
Everyone involved in computer system validation
Anyone selecting computer systems intended for FDA regulated
Information technology professionals responsible for files or network
Quality professionals who organize, document and verify system
Executives evaluating requirements Part 11 compliant systems
Price Tags
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299

Speaker Profile:

To know more visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1213

Herman Wong is a Washington DC-based consultant for computer
systems in FDA-regulated industry. He has been in the industry for over
12 years and is the Director of the Information Technology department
at Amarex, a full service pharmaceutical product development company
based in Germantown, MD. His key expertise is in training of IT
personnel in FDA-regulated industry, creating, managing and
implementing Part 11 compliant computer systems. Since 2005, Mr.
Wong has been evaluating EDC systems for Part 11 compliance at
small and big organizations including some of the largest US federal
organizations and large pharmaceutical companies.