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HomeWorkshop RegistrationWebinarsIn-House WorkshopsGovernment EmployeesOffice Hours

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 and webinar series!
(For more info on GMQA's upcoming Webinars click here)


Current Perspectives for U.S. FDA Compliance

(February 22-23, 2016, La Jolla, CA, US)--SOLD OUT, waiting list only
(April 18-19, 2016, Dublin, Ireland)
(May 23-24, 2016, Austin, TX, US)


(February 24-25, 2016, La Jolla, CA, US)
(April 20-21, 2016, Dublin, Ireland)
(May 25-26, 2016, Austin, TX, US)
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; MHRA Data Integrity Guidelines; 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 Level 1: 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
*  MHRA, WHO, & FDA Data Integrity Guidance
*  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

Some of the Level 2: Advanced Data Integrity Workshop's Highlights ...

*  Management Culture that Fosters Data Integrity Assurance
*  The Potential Power and Pitfalls of Metrics
*  Governance Structures for Data Integrity Compliance and Potential 
    Roles and Responsibilities for a Data Integrity Compliance Officer
*  Integrating Ethics into GxP Compliance and Quality Systems
*  Incentivizing Data Integrity
*  Leveraging the Electronic Paradigm Shift for Operational Excellence
*  Data Process Mapping & Aligning "Data Life Cycle" with QbD and QRM 
    Across the Product Life Cycle
*  Train-the-Trainer: Developing and Implementing a Data Integrity Training Program
*  "Critical Thinking" Skills Development Exercises for Quality Auditors
*  Integrating Data Integrity into Supplier Management: Quality Agreements and Monitoring
*  Update on Current Enforcement, including 483s and Warning Letters
*  Experience sharing and discussions among experienced data integrity compliance teams: 
    "What has worked best?"
*  More Case Studies
THE INSTRUCTOR  Monica Cahilly has 24+ years consulting experience with specialized interest in (and enthusiasm for) Data Integrity Assurance, Quality 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 US FDA investigators and other Health Authorities 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, ISPE, and is RQAP-GLP.
Click Here
PLEASE NOTE:  Space is limited to allow for interactive participation. Please register early.

GMQA's Upcoming 2016 Workshop Topics, Schedule, Locations ...

Level 1: Data Integrity: 22-23 February 2016, La Jolla, CA, US (SOLD OUT)
18-19 April 2016, Dublin, Ireland
23-24 May 2016, Austin, TX, US
... see details on Data Integrity workshop above

Level 2: Advanced Data Integrity / Train-the-Trainer: 24-25 February 2016, La Jolla, CA, US; 
20-21 April 2016, Dublin, Ireland 
25-26 May 2016, Austin, TX, US
... see details on Advanced workshop above

Level 3:  Critical Thinking & Advanced Forensic Auditing: dates and location to be announced;
pre-requisites: this workshop designed for those who have already attended Levels 1 & 2 workshops 
and have at least 5+ years GxP audit experience
...details to be announced 
** PREREQUISITE: The Advanced Data Integrity / Train-the-Trainer workshop is designed for those who have
already attended the GMQA Data Integrity Workshop.  However, those interested in attending both workshops -- i.e., the Data Integrity Assurance Workshop and the Advanced Data Integrity Workshop -- may do so sequentially, in the same week.