Source: http://onlinecompliancepanel.com/webinar/Systems-Validation-Made-Easy-500131
Timestamp: 2019-08-18 02:54:54
Document Index: 712439671

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Basic Framework for Computer Systems Validation | An Easy Approach
Systems Validation Made Easy
21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, proper documentation is a daunting task.
Instructor: Herman Wong
Product ID: 500131
09/25/2013 10:59 PM Training Topic:	Systems Validation Made Easy Instructor:	Herman Wong
In this seminar, we will simplify the validation process and provide practical tips in creating validation documents and procedures that will have you ready for your next audit. We will also provide you with helpful tips when validating commercial off-the-shelf (COTS) software.
This seminar will discuss the basics of computerized systems validation and the procedural controls to maintain compliance. Validation is on-going effort from development all the way to eventual retirement. You will hear about validation plans, user requirements, test plans, test reports, change controls, standard operating procedures, data backup and business continuity. Case studies will be used to highlight common issues and potential solutions.
Validation Plans, Requirements, Specifications, and Test Reports
Recommended SOPS
Tips when validating COTS software
Common audit findings and tips for a successful audit
Everyone involved in computer system validation
Anyone selecting computer systems intended for FDA regulated environments
Information technology professionals responsible for files or network locations
Executives evaluating requirements Part 11 compliant systems
Popular Courses by Herman Wong
Auditing for 21 CFR Part 11
Part 11 Compliance and the Role of Standard Operating Procedures
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 (www.amarexcro.com). 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.