Meetings & Seminars
eLearning On-Demand Courses
What is the "raw data" which is produced in your laboratory today? Is it the hard copy report which is printed from the instrument at the end of an analysis? And are the source electronic files on the instrument only a back-up copy of the printed data? Or is there more to it? Is there information in the electronic source files that may never be printed, yet may implicate data integrity or reliability? Do your laboratory supervisors and QA unit know how to find this information? Or are they only looking at printouts? In this live interactive session we will discuss the concept of managing electronic source data generated by your Chromatography Data System (such as Empower 2) as "raw data" to ensure the integrity of the reported data. We will discuss reviewing this data and the audit trails which are generated during data collection.
Our speaker for this session is Monica Cahilly, President, Green Mountain Quality Assurance, LLC has been consulting nationally and internationally for 23 years, with specialized interest in Data Integrity Assurance, 21 CFR Part 11 and Computer Systems Validation. Monica’s work includes data integrity inspections, application integrity policy, consent decree audits, preparing responses and corrective action plans for FDA regulatory observations, developing global and site Data Integrity and computer / Part 11 compliance programs, and training. Monica was invited in February 2009 by U.S. FDA to present to CDER Offices of Compliance the topic of ‘Detecting Aberrant GxP Data and Handling Practices’ and has subsequently been invited to provide on-going training in 2010 through 2015 in the topic of Data Integrity Investigations to U.S. FDA as well as to the World Health Organization (WHO), the Chinese National Institute of Food and Drug Control (NIFDC), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Irish Health Products Regulatory Agency (HPRA), Health Canada (HC), the European Medicines Agency (EMA), the Italian Medicines Agency (AIFA), China Food and Drug Administration (CFDA), Swissmedic, and others. Monica’s most recent interests include working in healthcare policy to prevent and detect data integrity issues as these relate to safe, effective, and cost-effective medicines. Monica has a bachelor’s degree in Biochemistry from Dartmouth College, a master’s degree in Genetic Toxicology from M.I.T., is a member of ISPE, PDA, DIA, and SQA and is RQAP-GLP.
·Understanding the implications of 21 CFR Part 11 to ensure the integrity of the reported data·Understanding the importance of audit trails·FDA inspections related to chromatographic analyses·Example 483s and warning letters·How to put a program in place to prevent your organization from getting a 483 and/or a warning letter for data integrity
1:00 PM to 2:30 PM EDT
This includes live Q&A session
This includes live Q&A session
This web-based training course will be delivered via Centra.
System and Event Requirements:• Windows 2000, Windows XP, Windows Vista • Internet Explorer 5.01, Netscape 7.2, Firefox 1.0 or later. • 28.8 kbps or faster Internet connection • P350+ MHz, 128+ MB Memory • 800x600 16-bit color display or better • Sound card and speakers• Disable Pop Up Blockers for the Event
Each attendee will receive a PDF of the training slides for reference and a Certificate of Attendance.
No travel information is currently available for this course.