This course will take you through five modules of information to Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. Introduction ICH Q9 – Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decisionmaking applications. Use of product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Management – Regulatory Perspective U. All quality risk evaluations must be based on scientific and process-specific knowledge and ultimately linked primarily to the protection of the patient – Risk assessment is based on the strong understanding of the underlying science, applicable regulations and related processes involved with the risk under analysis.

These principles are aligned with, and in some instances expand beyond, those already defined by ICH Q9 and are included in this report. The resulting eight highest graded cases studies are provided under Case Studies below. The studies demonstrate the baseline need to choose the appropriate risk methodology for the targeted need, taking into account the degree of complexity and risk involved for the specific subject of concern. A Life-Cycle Multi-Phase Approach Jackelyn Rodriguez This article provides a life-cycle methodology in a multi-phase approach that includes an effective. To make this website work, we log user data and share it with processors. September Share an applied and practical approach to perform. Helena Paulina Walker 3 years ago Views:

At this stage of the QRM process, care should be taken to not exclude those operations which may be simply perceived as low risk, without fully evaluating the actual potential influences and associated potential risks involved.

Confidence Intervals for Population Forecasts: Method used to identify all root causes of an assumed failure or problem. Helena Paulina Walker 3 years ago Views: Specific roles and responsibilities for each functional area participating infunctional equivalence assessments should be clearly defined see beigetriangles in Figure 2.


Page Part 1 Overview of clinical governance 1 Clinical governance the concept Purposes Why clinical governance The evolution to accountability for patient care quality and safety The.

Case study rmwg-o3 functional equivalence for equipment

Our business exposes us to strategic, credit, market, liquidity, compliance. Team unanimously agreesthat these risks have low probabilities of occurring.

The level of documentation of the risk management process to render an appropriate risk assessment should be commensurate with the level of risk. While the authors have attempted to include case studies that represent approaches that appear to be consistent with current good manufacturing practices, the content and decisions made by each equivalencr assessment exercise represent the opinions of the authoring firm.

Case_Study_RMWG_-_Functional_Equivalence_for_Equipment_Replacements_(rev_1) – Documents

Making great ideas into profitable. Ganeshkumar Palanichamy Abstract Medical devices developed for human application are used for diagnostic or treatment More information.

The collected case studies demonstrate that there is a wide range of applications for the use of structured risk management analysis to facilitate effective quality decision activities. Training and qualification curricula for personnel initiating change controls where functional equivalence will be assessed Equipment change control SOPs that direct the functional equivalence assessment process for parts replacements Maintenance systems inventory process control flow Training is required to be performed on these updated documents and training records are periodically audited for compliance.

case study rmwg-o3 functional equivalence for equipment

However, it is not uncommon for pharmaceuticalmanufacturers to resort to procuring and installing replacement parts that are notidentical to the srcinal parts due to changes affected by parts suppliers productredesigns, discontinuations, etc.

Defining the RiskQuestion The risk question functionap for the subject case study is: Please download to get full document. We are always happy to assist you.

How to write an introduction in a persuasive essay Nov 18, Tavaana Exclusive Case Study: Risk Assessment and Management Allen L. Bring your medical device to market faster 1 My Perspective Work with start up medical device companies Goal: Risk-methodology used to define factors with greatest potential to impact product performance QbD development. Additionally, this information should be communicated to stakeholders for their information and to ensure their support.


case study rmwg-o3 functional equivalence for equipment

Quality Risk Management Q9. This approach minimized both gaps and redundancies in the assessment efforts, while providing a common assessment foe format to facilitate overall review of the assessment package.

case study rmwg-o3 functional equivalence for equipment

Consent decree, product seizure, regulatoryimposed cessation of operations or equivalent. Risk Control For each of the two areas of significant risk identified in the FTAs andsummarized above, associated risk control plans were established. This presentation is the opinion of the presenter, and does More information. Diagram 1- Quality Risk Evaluation Pyramid. The analysis was equipmeng into the fault tree structure depicted below in Figure1.

Case study rmwg-o3 functional equivalence for equipment

All materials on our website are shared by users. These case studies were selected against a core set of criteria see Introduction above designed to identify models that embody the intent and spirit of ICH Q9.

Enterprise Risk Management Policy Name: The functional equivalence assessment process was historicallydependent wquivalence human judgment, expertise, and experienceProcess risks potential breakdowns of the process were qualitative innature, and were difficult to functkonal with specificityGiven these observations, the risk assessment team selected Fault Tree Analysis FTA as the risk assessment method since it is well suited for analysis ofqualitative fault conditions that may be related to human performance factors.

The resulting eight highest graded cases studies are provided under Case Studies below.