Webinar On Part 11 Compliance and the Role of Standard Operating Procedures

MessageThis Webinar is over
Date Apr 10, 2014
Time 13:00
Cost $249.00
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, it is important to remember that not only are technical controls but there are procedural controls as well. In this seminar, we will simplify the regulatory requirements and provide practical tips in creating standard operating procedures that will have you ready for your next audit. We will also provide you with helpful tips when purchasing commercial off-the-shelf (COTS) software.

This seminar will discuss the basics of Part 11 requirements and needed procedural controls to maintain compliance. You will hear about validation requirements, system security protocols, access control, data backup, recovery and contingency plans, as well as change control. Case studies will be used to highlight common issues and potential solutions.

Areas Covered in the Session :
    Review the key 21 CFR Part 11 requirements
    Standard Operating Procedures for computer systems
    Validation of computer systems
    Tips when purchasing COTS software
    Common audit findings and tips for a successful audit
Who Will Benefit:
This webinar will provide valuable information to:
    Clinical trial sites, manufacturers, and sponsors
    Everyone involved in computer system validation
    Anyone selecting computer systems intended for FDA regulated environments
    Information technology professionals responsible for files or network locations
    Quality professionals who organize, document and verify system compliance
    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

For more information contact

5939 Candlebrook Ct,
Mississauga, ON L5V 2V6,
Customer Support : #416-915-4458
Email : support@compliancetrainings.com.


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