GMQA's highly interactive one and two-day workshops focus on data integrity assurance and investigations, including current perspectives for CGxP compliance.
Data Integrity Workshop Level 1 - New Jersey (12-13 November 2018)
Data Integrity Workshop Level 1 - New Jersey (12-13 November 2018)
All pricing is per person.
See information below about government employee and group rate discounts.
Level 1: Data Integrity Assurance & Investigations of Electronic Data and Computerized Systems
Basking Ridge, New Jersey (30 minutes from EWR airport)
Olde Mill Inn, https://www.oldemillinn.com/
Mon, November 12, 2018 8:30am through Tue, November 13, 2018 4:30pm
This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to ensuring Data Integrity and compliance with 21 CFR Part 11, including:
- 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
- CGXP Requirements for Data Integrity, including Current Health Authority Data Integrity Guidances
- 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
- Case study of hands-on live system audit to detect data integrity issues
- And much more
The Level 1 workshop is designed for personnel responsible for data integrity (i.e., those who create, review and approve data in any GxP Operational role)—as well as novice and advanced Quality & Compliance auditors, Health Authorities, System Users, IT professionals, CSV and Engineering, Management, and more. Participants will have the opportunity to discuss recent industry standards, regulations and guidances and current regulatory expectations, case studies, audit and inspection approaches, assessment tools, and FDA 483s and warning letters. Attendees will also be able to participate in a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.
The 12-13 November 2018 (Level 1) Data Integrity Workshop will be held will be held at the historic Olde Mill Inn in Basking Ridge, New Jersey, https://www.oldemillinn.com/ a boutique hotel centrally located in New Jersey, near the charming villages of Bernardsville, NJ and Basking Ridge, NJ. The Olde Mill Inn, in the lovely Somerset Hills of the "Garden State", is only a short 30-minute drive from the Newark (EWR) airport, a 1-hour drive from New York City, and easily accessible on the NJ Transit Train line. A limited number of sleeping rooms have been reserved at a discounted rate for “Green Mountain Quality Assurance” of $210/night; please hurry to reserve by phoning +1-800-585-4461 or +1-908-221-1100 no later than 30 October 2018.
*Payment for more than one person: If you are submitting payment for someone other than or in addition to yourself, please be ready to send us their names and contact information with the payment using the form provided at checkout.
**PREREQUISITES: The GMQA Level 2 Data Integrity Governance Programs, 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 those with at least 5+ years of GXP industry experience who have completed both the GMQA Level 1 and Level 2 Workshops.
WORKSHOP SCHEDULE: Workshop registration will be held on the first day of each workshop from 7:30-8:30 a.m. Each day's session will begin at 8:30 a.m. The first day of each workshop will end at 5:00 p.m. and the last day of each workshop will end at 4:30 p.m. to allow participants to catch evening flights.
HOTEL RATES: Discounted hotel rates are often available for a limited number of rooms if reserved 30 days prior to the workshop start date. To determine availability, contact the hotel directly and request the "Green Mountain Quality Assurance Data Integrity Workshops" room rate.
FOR GROUP REGISTRATION: Discounted pricing is offered to groups of 3+ from a single organization who register at the same time for the same event. *Please note that only one promo code maybe used per order.
For groups of 3-5, please use coupon code GROUP3-5 to receive a 10% discount on your registration. For groups of 6-9, please use coupon code GROUP6-9 to receive a 15% discount on your registration. For groups of 10 or more, please use coupon code GROUP10+ to receive a 25% discount on your registration.
In order to receive the group discount, please make sure to include fellow attendees’ names and email addresses in your checkout form.
FOR GOVERNMENT EMPLOYEES: Green Mountain Quality Assurance, LLC provides special discounted pricing for on-site as well as off-site regional training programs and workshops for the employees of all GXP Health Authorities. Please use coupon code GOVT50 at checkout to receive the discounted government employee rate. If you have any questions, please do not hesitate to contact us for more information.
REGISTRATION QUESTIONS AND PAYMENT POLICIES: For questions on other ways to register, please visit our frequently asked questions page:
PAYMENT PROCESSING ERRORS: If the payment fails to process, please check your credit card details to be sure the billing address matches that for the credit card. If your payment continues to be blocked (which may happen for certain credit cards when charges are made in USD from non-U.S. locations), you may need to contact your credit card company to authorize the charge. We can also process your payment using our offline system. Please contact us anytime at info@GMQA.net for assistance.
CANCELLATION & SUBSTITUTION POLICIES: Cancellations received 10 or more days prior to the workshop start date may receive a refund minus a USD $100 processing fee. No refunds will be given within 10 days of the workshop start date. Substitutions are permitted at any time, including on the start date of the workshop, at no cost. Please submit requests for refunds or substitutions to info@GMQA.net.
TERMS & CONDITIONS: Individuals registering for all GMQA training events are required to abide by the terms and conditions set forth by GMQA regarding photography & video permissions and non-disclosure agreement. GMQA strictly prohibits all other audio and video recording of GMQA training events. GMQA reserves the right to cancel workshops and is not responsible for any airfare, hotel or other costs incurred by registrants.
QUESTIONS? For more information about these workshops or about GMQA, and its other workshops or on-site training and consulting services, please contact GMQA at +1-802-496-5810 or via email at info@GMQA.net.