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Green Mountain Quality Assurance, LLC
Helping You Build A Healthier World . . .
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Call: 1-802.496.5810
1497 Golf Course Road
Warren, VT 05674
Monica Cahilly of Green Mtn Quality Assurance, LLC
presents our currently most popular workshop series!
July 2-3, 2013, Frankfurt, Germany
July 30-31, 2013, Cambridge, MA
DATA INTEGRITY ASSURANCE & INVESTIGATIONS
OF ELECTRONIC DATA AND COMPUTERIZED SYSTEMS:
Current Perspectives for U.S. FDA Compliance
PREPARE FOR FDA's INSPECTIONAL APPROACH TO DATA INTEGRITY: This highly interactive 2-day workshop, filled with numerous case studies from all GxP areas, provides participants with knowledge and tools to effectively use, monitor, control and assure the integrity of electronic data and computerized systems. Designed for both novice QA professional and System Users as well as experienced QA CSV and IT professionals, this course explores foundational regulatory requirements for electronic data and computerized systems and current industry standards and FDA regulatory expectations. Persons in any GxP-regulated organization who are responsible for the creation, review, approval and/or reporting of data may find controls to ensure data integrity of special interest. Special topics include: Detecting and Preventing Data Integrity Issues; Conducting Effective Inspections of Electronic Data and Computer Compliance at Contract Facilities; EU Annex 11; Current FDA Enforcement of Part 11; and more. Participants will review and have the opportunity to discuss Computerized Systems Validation, 21 CFR Part 11, audit and inspection approaches, assessment tools, case studies, and FDA 483s and warning letters.
Some of the Data Integrity Workshop's Highlights
* Data Integrity -- Risk-Based Approach to Preventing & Detecting
* Data Life Cycle Design and Controls
* Validation for Data Integrity
* 21 CFR Part 11: Electronic Records, Electronic Signatures
* EU Annex 11
* Data Integrity Compliance Plans and Accountability Structures
* Techniques to Identify and Investigate Aberrant Data Patterns
* Reviewing electronic data and metadata--such as audit trails
* Risk assessment tools
* Conducting mock FDA inspections of facilities and electronic data
* Case study of hands-on live system audit to detect data integrity issues
* And much more
THE INSTRUCTOR Monica Cahilly has 20+ years consulting experience with specialized interest in (and enthusiasm for) Data Integrity Assurance, Risk Management, 21 CFR Part 11 compliance, working with domestic and international companies regulated by FDA GMP / GLP / GCP / QS Reg, VICH, and more, as well as in university and R&D settings. Monica was invited to train FDA on the topic of "Detecting Aberrant GxP Data and Handling" in 2009 and has been conducting training of FDA investigators since May 2010. Monica holds a B.A. Biochemistry from Dartmouth College, a M.S. Genetic Toxicology from MIT, is a member of PDA, DIA, SQA, NERCSQA, and ISPE, and is RQAP-GLP.
TO REGISTER FOR DATA INTEGRITY WORKSHOPS
PLEASE NOTE: Space is limited to allow for interactive participation. Please register early.
GMQA's 2013 Workshop Topics, Schedule, Locations ...
Data Integrity: July 2-3, Frankfurt, Germany
Data Integrity: July 30-31, 2013, Cambridge, MA
... see details on Data Integrity workshop above
Others ...
* Pre-Approval Inspections--with Deb Pagano
* Train-the-Trainer for Data Integrity
... more information, including dates and locations, on these workshops to follow
