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This presentation gives a summary of the New Draft FDA Quality Metrics Technical Conformance Guide.
US FDA Quality Metrics Technical Conformance Guide
US FDA Quality Metrics Technical Conformance Guide
GMP EDUCATION : Not for Profit Organization
The IFPAC Session: Controlling excipient impact during the product lifecycle. Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter. This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release. Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
NIPTE Roadmap 2017 Discussion @ IFPAC 2017
NIPTE Roadmap 2017 Discussion @ IFPAC 2017
Ajaz Hussain
Emergency: “No-pain No-gain” Standard: “Plan Do Check & Act” Pathfinders: B1: “Don’t Use & Don’t Tell”; no more! B2: Every vertex can be a Tipping Point G1: Same and Similar G2: Synthesis & Analysis
Pharmaceutical Quality by Design Travel Options Keynote @ Patheon QbD 2016
Pharmaceutical Quality by Design Travel Options Keynote @ Patheon QbD 2016
Ajaz Hussain
In 2015 FDA reorganized OPS to the Office of Pharmaceutical Quality (OPQ) and added an emphasis on One Quality Voice. In 2017 novel pharmaceutical technologies, the aspirational 21st Century Cures Act, and the President-elect Trump’s Administration are juxtaposed to re-shape, perhaps radically so, the Critical Path transformation underway since the beginning of this century. How will the Nation’s life-science research priorities change? What should be the next steps to optimally integrate 21st Century Quality, Cures and the Voice of Patients? What can/should NIPTE do next? Do better? Do more -be the third leg of the stool? This report, From Roadblocks to Roadmap 2017, with 2020 Vision, reviews and reflects on strategic directions emphasized by NIPTE in 2016. It recommends ways to strengthen the Voice of NIPTE to advocate its mission more persuasively and to facilitate its members apply their full potential in the interest of the Nation.
From Roadblocks to Roadmap 2017, with a 2020 Vision
From Roadblocks to Roadmap 2017, with a 2020 Vision
Ajaz Hussain
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve! Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order) The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking. A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
NIPTE Conference 2016 Keynote Ajaz Hussain 09272016 Final
NIPTE Conference 2016 Keynote Ajaz Hussain 09272016 Final
Ajaz Hussain
This presentation give a detailed overview of the PICS draft guidance on Data Integrity and Management.
New PICS Guidance on Data Integrity and Management.
New PICS Guidance on Data Integrity and Management.
GMP EDUCATION : Not for Profit Organization
Critical Update — Navigate the 2016 FDA Data Integrity Compliance Draft Guidance and Other Global Regulations Evaluate the Global Regulatory Landscape Expectations of the 2016 FDA Draft Guidance Overcome Top Challenges Proactive Approach to Assurance of Data Integrity Bonus Material
Data Integrity Validation Keynote Address Boston August 2016
Data Integrity Validation Keynote Address Boston August 2016
Ajaz Hussain
This presentation gives a summary of US FDA guidance on Data Integrity.
Presentation on US FDA Data Integrity Guidance.
Presentation on US FDA Data Integrity Guidance.
GMP EDUCATION : Not for Profit Organization
Recommended
This presentation gives a summary of the New Draft FDA Quality Metrics Technical Conformance Guide.
US FDA Quality Metrics Technical Conformance Guide
US FDA Quality Metrics Technical Conformance Guide
GMP EDUCATION : Not for Profit Organization
The IFPAC Session: Controlling excipient impact during the product lifecycle. Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter. This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release. Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
NIPTE Roadmap 2017 Discussion @ IFPAC 2017
NIPTE Roadmap 2017 Discussion @ IFPAC 2017
Ajaz Hussain
Emergency: “No-pain No-gain” Standard: “Plan Do Check & Act” Pathfinders: B1: “Don’t Use & Don’t Tell”; no more! B2: Every vertex can be a Tipping Point G1: Same and Similar G2: Synthesis & Analysis
Pharmaceutical Quality by Design Travel Options Keynote @ Patheon QbD 2016
Pharmaceutical Quality by Design Travel Options Keynote @ Patheon QbD 2016
Ajaz Hussain
In 2015 FDA reorganized OPS to the Office of Pharmaceutical Quality (OPQ) and added an emphasis on One Quality Voice. In 2017 novel pharmaceutical technologies, the aspirational 21st Century Cures Act, and the President-elect Trump’s Administration are juxtaposed to re-shape, perhaps radically so, the Critical Path transformation underway since the beginning of this century. How will the Nation’s life-science research priorities change? What should be the next steps to optimally integrate 21st Century Quality, Cures and the Voice of Patients? What can/should NIPTE do next? Do better? Do more -be the third leg of the stool? This report, From Roadblocks to Roadmap 2017, with 2020 Vision, reviews and reflects on strategic directions emphasized by NIPTE in 2016. It recommends ways to strengthen the Voice of NIPTE to advocate its mission more persuasively and to facilitate its members apply their full potential in the interest of the Nation.
From Roadblocks to Roadmap 2017, with a 2020 Vision
From Roadblocks to Roadmap 2017, with a 2020 Vision
Ajaz Hussain
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve! Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order) The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking. A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
NIPTE Conference 2016 Keynote Ajaz Hussain 09272016 Final
NIPTE Conference 2016 Keynote Ajaz Hussain 09272016 Final
Ajaz Hussain
This presentation give a detailed overview of the PICS draft guidance on Data Integrity and Management.
New PICS Guidance on Data Integrity and Management.
New PICS Guidance on Data Integrity and Management.
GMP EDUCATION : Not for Profit Organization
Critical Update — Navigate the 2016 FDA Data Integrity Compliance Draft Guidance and Other Global Regulations Evaluate the Global Regulatory Landscape Expectations of the 2016 FDA Draft Guidance Overcome Top Challenges Proactive Approach to Assurance of Data Integrity Bonus Material
Data Integrity Validation Keynote Address Boston August 2016
Data Integrity Validation Keynote Address Boston August 2016
Ajaz Hussain
This presentation gives a summary of US FDA guidance on Data Integrity.
Presentation on US FDA Data Integrity Guidance.
Presentation on US FDA Data Integrity Guidance.
GMP EDUCATION : Not for Profit Organization
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