Conference Description:

Course "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This seminar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

As a "GxP" system following Good Manufacturing, Laboratory and Clinical Practices; the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.

This seminar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

Location: Boston, MA Date: June 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON

Price:
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)
Until May 10, Early Bird Price: $1,295.00 From May 11 to June 19, Regular Price: $1,495.00
Sponsorship Program benefits for “FDA Trends for CSV Compliance and Enforcement” seminar
For More Information- https://www.globalcompliancepanel.com/co ntrol/sponsorship
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
[email protected] m
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - https://www.globalcompliancepanel.com/co ntrol/globalseminars/~product_id=901786S EMINAR?SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalc ompliancepanelindia/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlob alCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel