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 2 - Amsterdam (03-04 October 2018) $1600.00
Data Integrity Workshop Level 2 - Amsterdam (03-04 October 2018) $1600.00
All pricing is per person.
See information below about government employee and group rate discounts.
Level 2: Data Integrity Governance Programs, including Train-the-Trainer & Advanced Topics
Amsterdam, The Netherlands
Kimpton De Witt Hotel, http://www.kimptondewitthotel.com/
Wed, 03 October 2018 8:30am through Thu, 04 October 2018 4:30pm
This 2-day workshop builds upon the materials covered in the Level 1 “Data Integrity Assurance” workshop and provides more in-depth material, advanced topic discussions, additional case studies, and tools and discussions to build an effective internal training program to assure data integrity and inspection-readiness, including:
- Management Governance & Quality Culture that Fosters Data Integrity Assurance and Innovation
- Quality Risk Management and Risk-Based Data Integrity Plans
- The Potential Power and Pitfalls of Metrics
- Building a GxP Data Governance and "Data Science" Program
- Data Process Mapping & Aligning "Data Life Cycle" with QbD and QRM across the Product Life Cycle
- Organizational Roles and Responsibilities
- Integrating Ethics into GxP Compliance and Quality Systems
- Incentivizing Data Integrity and Operational Excellence
- 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 Data Monitoring
- Experience sharing and discussions among experienced data integrity compliance teams: "What has worked best?"
- More Case Studies
The Level 2 workshop is designed for personnel who have completed the GMQA Level 1 workshop and are interested in more in-depth coverage of the subject material, including more applied learnings through case studies and small group activities. The Level 2 workshop may be of particular interest to those in the following roles: Senior Quality and Management; those establishing and managing Data Integrity Compliance Programs / GxP Data Governance Programs, Quality Auditors and Health Authorities; Quality Risk Management, Management Governance and Knowledge Management program teams; personnel responsible for establishing Data Integrity Training Programs, Information Technology and Computer Validation personnel; as well as personnel in Operational roles preparing for data integrity inspections.
The 01-02 October 2018 (Level 1) Data Integrity Workshop and the 03-04 October 2018 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop and the 05 October 2018 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity will be held will be held at the lovely Kimpton De Witt Hotel in Amsterdam, The Netherlands, http://www.kimptondewitthotel.com/. This boutique hotel is situated in heart of Amsterdam Palace Quarter, with easy access to Amsterdam's City Centre, historical canals, and lively cafes. A limited number of sleeping rooms have been reserved at a discounted rate for the “Data Integrity Workshops / Green Mountain Quality Assurance” conference rate of 239€/night single room with breakfast; please hurry to reserve by the following booking link (Kimpton Hotel Booking) or phoning +31 (0) 20 52 11 852 no later than 01 September 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 when adding workshops to your cart.
**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.