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21 CFR Part 11 Validation Checklist | Computer Systems Validation

21 CFR Part 11 Validation Checklist

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Who should attend?

Information Technology Analysts Information Technology Developers and Testers QC/QA Managers and Analysts Clinical Data Managers and Scientists Analytical Chemists Laboratory Managers Automation Analysts Manufacturing and Supply Chain Managers and Analysts Computer System Validation Specialists GMP Training Specialists Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas Business System/Application Testers in FDA-Regulated Functional Area

Details

Course "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets their responsibility for meeting it. As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

 

Location: Boston, MA Date:  January 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM

Venue: Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA

 

Price:

 

Price: $1,295.00 (Seminar Fee for One Delegate)

Register now and save $200. (Early Bird)

Until December 10, Early Bird Price: $1,295.00 From December 11 to January 23, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees   Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901300SEMINAR?pharmiweb-January-2018-SEO

 

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Prices

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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