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Green Mountain Quality Assurance, LLC
Helping You Build A Healthier World . . .
Call: 1-802.496.5810
1497 Golf Course Road
Warren, VT 05674
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Monica Cahilly of Green Mtn Quality Assurance, LLC
presents our currently most popular workshop series!
DATA INTEGRITY ASSURANCE & INVESTIGATIONS
OF ELECTRONIC DATA AND COMPUTERIZED SYSTEMS:
Current Perspectives for U.S. FDA Compliance
Seattle, Washington
Tuesday & Wednesday, 5-6 June 2012
Location: Hotel Monaco-Seattle
Dublin, Ireland
Monday & Tuesday, 09-10 July 2012
Location: The Gibson Hotel
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 Workshop's Highlights
* Data Integrity -- Preventing & Detecting
* SaaS and Data Integrity in the "Cloud"
* CSV: Historical perspectives and Current industry Standards
* 21 CFR Part 11: Electronic Records, Electronic Signatures
* EU Annex 11
* Risk-based approaches to compliance and auditing
* Reviewing electronic data and metadata--such as audit trails
* Out-sourcing Information Technology (IT) support
* 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) Computer Systems Validation (CSV) and 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
PLEASE NOTE: Space is limited to 50 to allow for interactive participation. Please register early.
