Validation Archives - Page 8 of 9

Category: Validation

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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: INSIGHTS FROM OTHER INDUSTRIES

Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies toaddress the challenges and opportunities of implementing science and risk-based decision making andmanufacturing approaches. Since its inception, the PRST has continued to progress research […]

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Building Workstreams, Process Flows & Defining Critical Roles – Value Stream Emphasis

Join us as we discuss the setup for success – Defining Workstreams, Process Flows, and People.Building Workstreams – Generation of a high level view of the project• Defining workstreamso Categories of work – Centers of Excellence (COE)o Individuals or departments critical to the project successo Consisting of subject matter experts from specific areas• Creating workstreamso […]

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Successful Implementation of a 2-Stage Process Validation Program

Participants will benefit from understanding the current international regulations for 2-Stage Process Validation as well as realizing the significant business benefits that come from taking a science and risk-based approach.Facility Design and Qualification of Equipment and Utilities (FDA Stage 2.1)· Utilizing technology transfer data from stage 1 to support development of CQAs and CPPs.· Facility […]

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Successful Implementation of a 1 -Stage Process Validation Program

Participants will benefit from understanding the current international regulations for 1-Stage Process Validation as well as realizing the significant business benefits that come from taking a science and risk-based approach.Current Regulatory Expectations (FDA Stage 1)· Clarify similarities and differences between EU and US expectations· Establish a three-stage, science and risk-based, lifecycle process validation programmed.· impact […]

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Data-Based Process Monitoring, Control and Improvement: A Systematic Approach

Process monitoring, control and improvement has been at the heart of quality management for decades. The methodology continues to develop and has moved into a new era with the widespread availability of online data collection systems. This development creates the need for better utilization of the collected data for process monitoring, control and improvement.This presentation […]

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Category: Validation

IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: INSIGHTS FROM OTHER INDUSTRIES

Building Workstreams, Process Flows & Defining Critical Roles – Value Stream Emphasis

Successful Implementation of a 2-Stage Process Validation Program

Successful Implementation of a 1 -Stage Process Validation Program

Data-Based Process Monitoring, Control and Improvement: A Systematic Approach

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