Risk Management
PTM Consulting has always dealt with issues related to risk applied to different technical and organizational contexts.
The training proposal dedicated to Quality Risk Management finds its foundation in the ICH Q9 guideline and arrives at declining the topic of risk management both as a tool for risk assessment in decision-making to support quality, of projects and products, and as an operational tool to manage daily activities.
For more information about our training write to academy@ptm-consulting.it.
Courses Available ON DEMAND:
The introduction of ICHQ3D before and the request of EMA and FDA to assess the presence of Nitrosamines in drugs have put companies in a position to review the documentation of their products sometimes already on the market to ensure their quality and safety through the identification and assessment of the presence of unacceptable levels of impurities. A risk-based approach, as required by regulatory agencies, is a must, but not always simple to implement. The course presents how to manage and approach the management of impurities and how to maintain an up-to-date state of the relevant documentation.
Identifying and assessing the potential risks related to a potential downtime and the consequent impact in terms of business continuity and economic spill-over is a crucial activity to production. Through specific activities of Risk Assessment it is possible to create a business continuity plan and undertake mitigation actions such as not to compromise the production capacity. The course will present the tools of the Manufacturing Risk Assessment for Business Continuity also through some cases of implementation in the company.
Since September 2019, DP and API manufacturers as well as Marketing Authorization Holders (mahs) are engaged in risk-based evaluation of their products in order to identify and prevent the presence of unacceptable levels of impurities from Nitrosammine in drugs. Through the risk-based approach developed by PTM, the necessary steps to respond to regulatory requests will be illustrated.
Quality risk management has found multiple applications in pharmaceutical companies since the ICH Q9 guideline became part of GMP. Today, 15 years after its introduction, it is about to be revised. What will change? What impact will there be for the activities in the company? Starting from the ICH Q9 guideline and an update on its revision, the course will explore different areas of application in the company, bringing to light the advantages of its correct implementation. Some case studies will cover, for example, QRM to support the validation activities for inhalation formulations, optimization of a platform for the production of oral solids, support to the formulation development, development of a parenteral formulation.
The course will present possible uses and applications of the Failure Mode and Effect Analysis (FMEA) risk analysis tools. Practical guidance on how to build an FMEA through a dedicated workshop session will also be provided.
The course will present possible uses and applications of the Root Cause Analysis & Fault Tree Analysis (FTA) risk analysis tools. Practical guidance on how to build an FTA through a dedicated workshop session will also be provided.