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HomeWorkshop RegistrationPAI WorkshopTrain-the-Trainer WorkshopGovernment EmployeesWebinars

Call: 1-802.496.5810
1497 Golf Course Road
Warren, VT 05674

GMQA's WEBINAR TOPICS & SCHEDULE


 Thursday, 24 April 2014, 11:00 a.m. - 1:00 p.m. EST
DATA INTEGRITY ASSURANCE - CURRENT PERSPECTIVES FOR U.S. FDA COMPLIANCE
This webinar presents a 1.5 hour overview of the topic followed by a 30 minute question & answer period. To participate, please complete and submit the registration form below.

The participation fee is $399 for individuals, $1625 for Groups of less than 10 persons, and $2500 for Groups of 10 or more persons. Payment via PayPal or credit card can be submitted by clicking on the appropriate payment button below. To ensure your participation, please submit your payment when you register.

LINKING IN: Each registrant will be sent the link to the webinar no later than 24 hours prior to the webinar's start time.

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
(May 12-13, 2014, Dublin, Ireland)
(September 29-30, 2014, Baltimore, MD)

ADVANCED DATA INTEGRITY / TRAIN-THE-TRAINER **
(May 14-15, 2014, Dublin, Ireland)
(October 1-2, 2014, Baltimore, MD)
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

Some of the 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
*  Aligning "Data Life Cycle" with QbD and Risk Management Principles 
    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 Risk-Based 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, including new hands-on live system audit to detect
    data integrity issues
*  And much more
THE INSTRUCTOR  Monica Cahilly has 22+ 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, ISA, and ISPE, and is RQAP-GLP.
TO REGISTER FOR WORKSHOPS
Click Here
PLEASE NOTE:  Space is limited to allow for interactive participation. Please register early.

GMQA's 2014 Workshop Topics, Schedule, Locations ...

Data Integrity: May 12-13, Dublin, Ireland and September 29-30, Baltimore, MD
... see details on Data Integrity workshop above

Advanced Data Integrity / Train-the-Trainer: May 14-15, Dublin, Ireland and October 1-2, Baltimore, MD
... more information on this workshop to follow

Others ...
* Pre-Approval Inspections--with Deb Pagano
... more information, including dates and locations, on this workshop to follow​
** PREREQUISITE: The Advanced Data Integrity / Train-The-Trainer workshop is for those who have already 
attended the GMQA Data Integrity Workshop and have working knowledge of data integrity concepts.