The Doubletree by Hilton at Raleigh Durham Airport
4810 Page Creek Lane, Durham, NC 27703
GxP Technology Summit Heads to RTP, NC!
August 29-30, 2023
Attend in Research Triangle Park or Virtually!
There is much discussion (and a lot of questions) surrounding the implementation of new technology and how to optimize across the GxP lifecycle. Coupled with FDA’s new approach to critical thinking and modern risk assessments, the time has never been better to stay up to the minute on current regulations and the cutting-edge tools that will streamline processes, eliminate compliance challenges, reduce cost, and ultimately deliver patient-saving products faster. Don’t worry, we have you covered! Join us in Research Triangle Park and learn from the industry’s best who are paving the way.
Top Reasons to Attend
- Cut the BS – Regulation vs. Guidance vs. Standards (Part 11/Annex 11/QRM/ISO/GAMP™/ICH Q9)
- Regulatory compliance – What are the current trends and what’s on the horizon?
- Develop a risk-based Quality Culture
- Leverage new CSA testing methods (ad hoc, unscripted, etc.)
- Learn how to conduct automated testing (CSA, Machine Learning) – A case study
- Apply Quality Risk Management (QRM) over the lifecycle
- Learn how a major life science company digitized validation and achieved 100% paperless
- Understand where Agile is applicable (software, equipment)
- Understand how technology enhances process validation
- Implement and validate cloud technologies from VLMS to QRM
- Know what role data visibility plays in risk technology
- Hear a Keynote address – Ethics in technology
- Learn why do we need digital Continuous Process Verification (CPV)
- See a cleaning validation digitization case study
This event is appropriate for professionals working in the GxP environment looking for innovative technology solutions, to streamline processes, reduce costs, and ensure compliance, including:
- Quality Assurance
- Data Integrity
- Quality Control
- Manufacturing Management
- Project Management