FDA Trends for CSV Compliance and Enforcement | Boston Seminar 2018

Date : 25th June 2018 to 26th June 2018

Place : United States, Boston

Website :https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901786SEMINAR?allconferencealerts_june_2018_seo

Contact Person:John Robinson

Description:

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.

FDA Trends for CSV Compliance and Enforcement | Boston Seminar 2018 will be held in Boston,United States on date 2018-06-26

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Deadline for abstracts/proposals : 23rd June 2018

Keynote Speakers : Carolyn Troiano Carolyn Troiano has more than 35 years of experience in Computer System Validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA's guidance on electronic records and electronic signatures

Conference Highlights :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 o

Venue :Boston, MA, USA

Check the event website for more details.