Regulatory Challenges
- SUBJECT MATTER EXPERTS will address the challenges faced by Industry in implementing ANNEX 11 & 21 CFR part 11 requirements.
- Analysis of Regulatory Citations will be presented causes and preventive actions will be discussed.
Computer System Validation
These sessions will have presentations covering :
- How to implement Critical Thinking in CSV
- How to use AGILE methods in CSV
- How to adopt Scripted & Unscripted Testing in CSV
- How use CSV tools to support CSV evidence
- How to simplify validation of Category 3 & 4 systems
- Test Management & Test Automation
- Validation of RPA, AI/ML tools
IT Infrastructure Control and Compliance
- This session is intended to provide insights on meeting regulatory expectations for compliant Information Technology (IT) Infrastructure platforms, both traditional and cloud-based.
- The increasing prevalence of new technology has presented regulated companies with significant technological advantages, as well as a changed compliance model.
- This session will present a structured approach, including risk management, to the qualification, management, and control of IT Infrastructure platforms supporting GxP regulated applications.
- The session will provide a scalable qualification framework which can be applied to different platform types, across both the physical and virtualized space, in order to determine the extent and scope of qualification efforts.
- The session also provides an overview of industry best practices for the design, qualification, and operation of an IT Infrastructure with emphasis on the qualification requirements of the major components.
Laboratory Computerised Systems
- This session will present A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems.
- The Session will contain steps that scientists, suppliers and others involved in managing laboratory computerised system acquisition, implementation, and operations can use to verify laboratory systems are fit for their intended use.
- The session will provide a practical, risk-based approach for evaluating these systems, thus eliminating trial and error.
- By following the principles outlined in this session companies can save time and money, improve communication with external parties and achieve higher quality, better performing systems.
Process Control Systems
- This session will provide guidance to implement the framework of Risk Based Approach to a wide range of systems, from basic instruments to large, complex, distributed control systems.
- The goal of this session is to help users achieve process control systems that are fit for intended use and compliant with applicable regulations.
- The session also provides recommended good practices based on a life cycle approach for the development, maintenance, and management of process control systems.
- The session will elaborate the science-based Quality Risk Management, as described in ICH Q9 and GAMP® 5. It will describe the system life cycle from concept to retirement, providing a high level overview of the approach.
Data Integrity - Manufacturing Records
- Manufacturing systems, with their link to the physical process, have an obvious impact on patient safety and product quality.
- Careful consideration of data integrity risks, alongside all other risk types, provides a more complete assessment of the GMP risks associated with the system.
- In addition, there has been an increase in recent years of data integrity citations relating to manufacturing data.
- This session addresses the expectations for data integrity in a GMP environment to aid companies in meeting regulatory requirements and provides practical and pragmatic insights on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.