Key Steps for Risk Assessment
The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby significantly reduces your companies exposure to audit failures.
Risk management activities involve processes, methods, and tools for identifying, assessing and managing risks. These activities are conducted in a disciplined environment. It requires proactive decisions to continuously assess what could go wrong during the manufacturing of any product. This webinar addresses how to identify the critical risks and mitigate them. It provides a systemic prospective of QRM using the Swiss cheese model. Specifically, it focuses on key factors for a successful Risk Management process, the 7 key concepts in FDA's systems approach thinking to Risk Management, the required QRM documents and their contents and Risk Assessment methods and tools.
The webinar aims to equip and empower attendees with the knowledge of basic risk management terminology, the deployment of appropriate tools for risk assessment, FDA's audit care about for QRM , as well as how to apply risk management principles to various aspects of a quality system. Among the topics to be discussed are the key steps in the identification of risks, establishing a scoring criteria to analyze identified risks, use of the 5-p model for risk reduction, risk acceptance basics including factors that establish a risk acceptability criteria, elements of a Risk Control strategy and what and when to communicate with risk stakeholders. Since Risk Management is a dynamic process, topics will also include how to continuously monitor risks and integrate them into a continual improvement strategy, along with the management's role of ensuring the adherence to the strategy.
Why you should attend
: ICH Q8, Q9 and Q10 have been the bedrock of the regulatory agencies' regulations for pharmaceutical cGMPs for the 21st century. While adoption of these has been slow, some like Q9 and Q10 are increasingly coming into acceptance by the industry. Adoption of concepts such as Q8's QbD have been slow because it is still in its infancy and will require more time if it is to have the transformative effect first conceived by ICH. However, QRM (Q9) and Quality Systems (Q10) are increasingly coming into acceptance by the industry since their understanding is not as intricate and complex as QbD is. It is becoming increasingly evident that application of QRM (Q9) techniques would provide the refinement tools to formulate and validate the QbD (Q8) models of the processes. Hence a good understanding and application of QRM techniques and tools would be instrumental in the development of realistic QbD models that are more reflective of true process characterization and actual process behavior.
The approach to quality and risk management is dynamic in nature due to the evolution of science and technology. This dynamic nature imposes a challenging situation for companies since they are now required to keep themselves fully trained and informed of the changing regulations. Additionally, with the increasing formalization of QRM tools and techniques, regulatory agencies are requiring companies to establish Quality Risk Management Plans that are being used as starting points for their audits. The requirement for performing QRM coupled with QRM's dynamic nature increases companies' risk of audit failures. Citations arising from such audit failures are being addressed through a consistent documentable approach to risk management throughout the company irrespective of the business and manufacturing processes. This webinar addresses the "common language of risk" coupled with the documentation strategy required to maintain a defensible risk control strategy to meet compliance requirements.
Areas Covered in the Session:
Who Will Benefit:
- Characteristics, history & FDA’s involvement with QRM
- In perspective: QbD, QRM and Quality systems
- ICH Q9 Process
- Principles of QRM
- Key elements of QRM
- Characteristics of QRM
- Systemic processes and General Failure Types
- 7 Key concepts in FDA systems approach thinking
- Swiss cheese model for systemic related safety
- QRM documentation and their contents
- Factors for a successful Risk Management process
- Hazard, Harm, Risk concept
- Key steps in risk identification
- Use of scoring criteria and Heat Maps in analyzing and evaluating risks
- Risk reduction and Risk acceptance basics
- Factors that establish a Risk Acceptability criteria
- QRM tools used; their strengths and limitations
- Selection of appropriate tools for different circumstances
- Project Managers, Lead Engineers, Software Engineers
- Risk Managers and others Performing Risk Management Activities
- Those involved in process improvement
- Contractor, Consultants Providing Engineering and Validation Services
- QA, Regulatory Affairs, Engineering & IT personnel