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HomeWorkshop RegistrationWebinarsIn-House WorkshopsGovernment EmployeesOffice Hours

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

GMQA's WEBINAR TOPICS & SCHEDULE


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)

WORKSHOPS

Level 1: DATA INTEGRITY ASSURANCE & INVESTIGATIONS
OF ELECTRONIC DATA AND COMPUTERIZED SYSTEMS:
Current Perspectives for U.S. FDA Compliance

(May 23-24, 2016, Austin, TX, US)--moved to larger space, registration is open again!
​(September 5-6, 2016, Dublin, Ireland)

Level 2: DATA INTEGRITY GOVERNANCE PROGRAMS, 
INCLUDING TRAIN-THE-TRAINER & ADVANCED TOPICS **

(May 25-26, 2016, Austin, TX, US)--registration is open again; moved to larger space
(September 7-8, 2016, Dublin, Ireland)

Announcing Our Newest Workshop:

Level 3: CRITICAL THINKING & ADVANCED AUDITING 
FOR DATA INTEGRITY**

(August 31-September 1, Montreal, QC, Canada)
PREPARE FOR FDA's INSPECTIONAL APPROACH TO DATA INTEGRITY: Our highly interactive 2-day workshops, 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, conduct audits for data integrity compliance, and design and implement data integrity compliance programs.  Our workshops, offered in various levels that build upon previous levels, are designed for Quality & Compliance professionals, Management, Data Integrity Compliance Officers and Program Leads, Scientific and Laboratory, and Operations personnel from multiple GXP focus areas, as well as Computer Validation and IT professionals. 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; MHRA / WHO / FDA Data Integrity Guidelines; Current HA Enforcement of Data Integrity; and more.  Participants will review and have the opportunity to discuss audit and inspection approaches, assessment tools, case studies, and FDA 483s and warning letters & EU Non-Compliance Reports.  
Some of the Level 1 Workshop Highlights ...Electronic Data & Computerized Systems 

*  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 Workshop Highlights ...Data Integrity Governance Programs 

* 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

Some of the Level 3 Workshop Highlights ...Advanced Auditing for Data Integrity 

* Critical Thinking Skill Development Exercises
* Small Group Mock Inspection Exercises
* Inspecting Live Computer Systems for Data Integrity Controls
* Pivot Tables of Data Exports
* Pattern Recognition Exercises
* Interviewing Techniques
* Flags for Parallel Record-Keeping
* Recovering Deleted Data
* Evaluating Data Governance Programs
* Data Process Maps and Data Life Cycle Assessments
* Evaluation of Current Enforcement Trends, including FDA & EU citations
* Experience sharing and discussions among experienced auditors: "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.
TO REGISTER FOR WORKSHOPS
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 Assurance & Investigations of Electronic Data & Computerized Systems: 
23-24 May 2016, Austin, TX, US--moved to larger space, registration is open again!
05-06 September 2016, Dublin, Ireland
... see details on Level 1 workshop above

Level 2: Data Integrity Governance Programs, including Train-the-Trainer & Advanced Topics: 
25-26 May 2016, Austin, TX, US
07-08 September 2016, Dublin, Ireland
Pre-requisite: this workshop designed for those who have already attended Level 1 workshop
... see details on Level 2 workshop above

Level 3:  Critical Thinking & Advanced Forensic Auditing: 
31 August - 01 September 2016, Montreal, QC, Canada
Pre-requisites: this workshop designed for those who have already attended both Levels 1 & 2 workshops 
and have at least 5+ years GxP industry experience
...see details on Level 3 workshop above 
** PREREQUISITE: The GMQA Level 2 Data Integrity Governance Program, including Train-the-Trainer & Advanced Topics workshop is designed for those who have already attended the GMQA Level 1 Data Integrity Workshop.  Those interested in attending both the Level 1 and Level 2 workshops may do so sequentially, in the same week.  Similarly, the GMQA Level 3 Critical Thinking & Advanced Auditing for Data Integrity Workshop is designed for auditors with at least 5+ years of GXP industry experience who have completed both the GMQA Level 1 and Level 2 Workshops.