We are on a journey to make quality medicines affordable to all. In the 21st Century, this journey will be successful to the extent we recognize that quality has to be built-in by design and that it cannot be tested into products, utilize and improve a global Quality Management System (QMS), and implement science based risk assessment in our decision making. Pharmacopoeias are an integral part of this global QMS and have been setting public or market standards for medical products for many centuries. In the 21st Century, Pharmacopoeias can and should be a champion for the practice of quality by design. To do so most effectively it would be useful to recognize how, in the 21st Century, human factors help and hinder optimal development, and correct interpretation, of public or market standards in design, development, control and manufacturing decisions. To explore this aspect in this presentation, cognitive biases – blind spots or alleys – are collected and organized on topics relevant to this workshop: (a) Impurities & Contaminants, (b) Analytical Method Validation, and (c) Public/market standards and Release Testing. How to confront these biases will be discussed. Steps to help in maximally leveraging the Pharmacopoeias on the 21st Century journey will be highlighted.
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
This document discusses challenges in assuring pharmaceutical quality and proposes solutions. It begins with two case examples of companies reaching a "tipping point" in moving from reactive to proactive quality approaches. It then outlines how to effectively integrate process analytical technology (PAT) guidance and other quality guidelines to make continual improvement normal, easy and rewarding. Finally, it proposes understanding uncertainty and human factors when assuring quality, and providing a framework to classify gaps to address challenges. The overall message is that recognizing legacy issues and integrating quality approaches can help advance from problem-solving to error prevention.
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
Dr Venkateswarlu Memorial Lecture 2015Ajaz Hussain
Purpose of this talk is to request you to consider the following 4 Steps
1. Strengthening the ‘Culture of Quality’ – the focus of this talk
2. Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologies
3. Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory to the World
4. Leverage India’s Wisdom Traditions to provide leadership in setting the standards for Integrative Medicine so as to deliver a model of ‘Health Care for All’: Pharmacy to the World.
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
This document discusses challenges in assuring pharmaceutical quality and proposes solutions. It begins with two case examples of companies reaching a "tipping point" in moving from reactive to proactive quality approaches. It then outlines how to effectively integrate process analytical technology (PAT) guidance and other quality guidelines to make continual improvement normal, easy and rewarding. Finally, it proposes understanding uncertainty and human factors when assuring quality, and providing a framework to classify gaps to address challenges. The overall message is that recognizing legacy issues and integrating quality approaches can help advance from problem-solving to error prevention.
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
Dr Venkateswarlu Memorial Lecture 2015Ajaz Hussain
Purpose of this talk is to request you to consider the following 4 Steps
1. Strengthening the ‘Culture of Quality’ – the focus of this talk
2. Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologies
3. Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory to the World
4. Leverage India’s Wisdom Traditions to provide leadership in setting the standards for Integrative Medicine so as to deliver a model of ‘Health Care for All’: Pharmacy to the World.
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareAjaz Hussain
IDMA – UL SUMMIT 24 March 2015, Mumbai
"Evolving Quality Culture in Indian Pharmaceutical Industry“: Strengthening Our Culture of Quality
Organizational Culture, Good or Bad?
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
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
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.
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
The document discusses regulatory aspects of continuous pharmaceutical manufacturing. It summarizes that historically there has been regulatory opposition to new manufacturing techniques, but there is now a tipping point with regulatory preference shifting towards real-time controls, continuous manufacturing, and digital approaches. It outlines options for companies to either lead regulatory guidance, follow upcoming standards, or react in an emergency if inspections find issues. The overall message is that serious consideration is needed to develop a roadmap for modernizing manufacturing approaches.
From Roadblocks to Roadmap 2017, with a 2020 VisionAjaz 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.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
A platform for assurance & efficiency - Ajaz at USP PCM Mumbai 2017Ajaz Hussain
Why? Assurance is a critical to quality attribute
What? The Little Secret which erodes assurance patients need
How? Rapid development, design space and real-time control; mind shift
Roadmap to QbD is (should be) a roadmap to adult human developmentAjaz Hussain
This document summarizes a keynote presentation on using Quality by Design (QbD) as a roadmap for adult human development. The presentation discusses how QbD and pharmaceutical quality systems should aim for continual growth and development, rather than just following rules. It notes that some adults develop at different rates or not at all. The keynote also examines how biases can hold back pharmaceutical quality and discusses linking different stages of product development and manufacturing to achieve a systems-level approach to quality.
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
Re-thinking Pharmaceutical Technology Continuing Education in the Context of ...Ajaz Hussain
I wonder, seriously - Does working in some of the current GXP regulated environments impede adult human development?
Anticipating a glimpse of a framework for a 21st Century Pedagogy - One Quality Voice , continually developing professionals and improving PQS – in the interest of patients and the next generation of professionals.
Systems Engineering of Pharmaceutical Quality by Design 18 December 2017 Alb...Ajaz Hussain
Invitation by Prof. Olivier Lecoq to deliver a lecture at the School of Mines, Albi, France. The topics of interest are connected to the international world of the industrial pharmacy, so the drug development, the product and process quality, the GMP's, the international regulation, the authorities, the industries...
The talk you presented at the "International Rencontres in Pharmaceutical Engineering" in 2004 in Albi, could be an interesting idea to start with if you agree. The keywords being: PAT, FDA, pharmaceutical engineering of the 21st century!
Need and Urgency for Harmonization and One Quality VoiceAjaz Hussain
We are in the Experience Economy in which the demand for Assurance is increasing exponentially. Our quality systems are improving linearly, and we are falling behind in delivering the assurance needed by patients to realize therapeutic benefits of medicine we deliver. Industry's need to continually improve is urgent, but their ability to do so remains constrained despite the FDA initiatives. To realize FDA's vision of an agile pharmaceutical manufacturing systems ... Without the need extensive regulatory oversight, industry should be encouraged to "self-author" "performance standards" and regulators should harmonize on the global accessibility of the self-authored performance standards.
#AAPS2017 Need and Urgency for Harmonization and One Quality Voice. A. S. Hussain. Insight, Advice & Solutions LLC.
These slides were used for a invited presentation @ Patheon Seminar – Bridgewater, NJ, 31 July 2014.
Some modification have been made to connect the dots for the audience who will review this slide-deck on the internet.
This presentation provides a very brief snap-shot of a day long training program conducted recently at a company in India. In preparing the day long training session I had asked the following questions; (1) How to effectively communicate to an audience of a group of young and bright Indian professionals in any company in India and their supervisors/management about the importance of cGMPs and QbD? (2) How do I understand their challenges, perspectives and biases? (3) How do I connect with them to share the joy of Quality by Design?
The response received has been overwhelming from the audiences in India and yesterday at the Patheon Seminar in Bridgewater, NJ. I hope you will also the see some of the important dots and the connections. How this content connects to regulatory requirements is not covered in this slide deck – it connects via ‘A, B, C, D’ to 21 CFR, Quality Systems Approach to cGMP, ICH 7, 8, 9, 10, and 11.
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareAjaz Hussain
IDMA – UL SUMMIT 24 March 2015, Mumbai
"Evolving Quality Culture in Indian Pharmaceutical Industry“: Strengthening Our Culture of Quality
Organizational Culture, Good or Bad?
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
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
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.
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
The document discusses regulatory aspects of continuous pharmaceutical manufacturing. It summarizes that historically there has been regulatory opposition to new manufacturing techniques, but there is now a tipping point with regulatory preference shifting towards real-time controls, continuous manufacturing, and digital approaches. It outlines options for companies to either lead regulatory guidance, follow upcoming standards, or react in an emergency if inspections find issues. The overall message is that serious consideration is needed to develop a roadmap for modernizing manufacturing approaches.
From Roadblocks to Roadmap 2017, with a 2020 VisionAjaz 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.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
A platform for assurance & efficiency - Ajaz at USP PCM Mumbai 2017Ajaz Hussain
Why? Assurance is a critical to quality attribute
What? The Little Secret which erodes assurance patients need
How? Rapid development, design space and real-time control; mind shift
Roadmap to QbD is (should be) a roadmap to adult human developmentAjaz Hussain
This document summarizes a keynote presentation on using Quality by Design (QbD) as a roadmap for adult human development. The presentation discusses how QbD and pharmaceutical quality systems should aim for continual growth and development, rather than just following rules. It notes that some adults develop at different rates or not at all. The keynote also examines how biases can hold back pharmaceutical quality and discusses linking different stages of product development and manufacturing to achieve a systems-level approach to quality.
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
Re-thinking Pharmaceutical Technology Continuing Education in the Context of ...Ajaz Hussain
I wonder, seriously - Does working in some of the current GXP regulated environments impede adult human development?
Anticipating a glimpse of a framework for a 21st Century Pedagogy - One Quality Voice , continually developing professionals and improving PQS – in the interest of patients and the next generation of professionals.
Systems Engineering of Pharmaceutical Quality by Design 18 December 2017 Alb...Ajaz Hussain
Invitation by Prof. Olivier Lecoq to deliver a lecture at the School of Mines, Albi, France. The topics of interest are connected to the international world of the industrial pharmacy, so the drug development, the product and process quality, the GMP's, the international regulation, the authorities, the industries...
The talk you presented at the "International Rencontres in Pharmaceutical Engineering" in 2004 in Albi, could be an interesting idea to start with if you agree. The keywords being: PAT, FDA, pharmaceutical engineering of the 21st century!
Need and Urgency for Harmonization and One Quality VoiceAjaz Hussain
We are in the Experience Economy in which the demand for Assurance is increasing exponentially. Our quality systems are improving linearly, and we are falling behind in delivering the assurance needed by patients to realize therapeutic benefits of medicine we deliver. Industry's need to continually improve is urgent, but their ability to do so remains constrained despite the FDA initiatives. To realize FDA's vision of an agile pharmaceutical manufacturing systems ... Without the need extensive regulatory oversight, industry should be encouraged to "self-author" "performance standards" and regulators should harmonize on the global accessibility of the self-authored performance standards.
#AAPS2017 Need and Urgency for Harmonization and One Quality Voice. A. S. Hussain. Insight, Advice & Solutions LLC.
These slides were used for a invited presentation @ Patheon Seminar – Bridgewater, NJ, 31 July 2014.
Some modification have been made to connect the dots for the audience who will review this slide-deck on the internet.
This presentation provides a very brief snap-shot of a day long training program conducted recently at a company in India. In preparing the day long training session I had asked the following questions; (1) How to effectively communicate to an audience of a group of young and bright Indian professionals in any company in India and their supervisors/management about the importance of cGMPs and QbD? (2) How do I understand their challenges, perspectives and biases? (3) How do I connect with them to share the joy of Quality by Design?
The response received has been overwhelming from the audiences in India and yesterday at the Patheon Seminar in Bridgewater, NJ. I hope you will also the see some of the important dots and the connections. How this content connects to regulatory requirements is not covered in this slide deck – it connects via ‘A, B, C, D’ to 21 CFR, Quality Systems Approach to cGMP, ICH 7, 8, 9, 10, and 11.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that their drug be designated as a "Breakthrough Therapy". This designation is primarily based on the early clinical finding of substantial efficacy in s serious medical need indication. A Breakthrough Therapy Designation provides fast track program advantages alongside a frequent FDA guidance on an efficient drug development program. The FDA also makes an organizational commitment to involve experienced reviewers and senior management in such guidance. This presentation provides an overview of Breakthrough Therapy Designation and discusses why CMC aspects can lag-behind clinical development and how this may be addressed.
The time has come to seriously work on leveraging End-of-Phase II for setting regulatory specifications.
Bioequivalence – Still a Quality Achilles’ Heel? 16 October 2014Ajaz Hussain
This document summarizes a presentation on bioequivalence and pharmaceutical equivalence given by Dr. Ajaz Hussain. Some key points included:
- Pharmaceutical equivalence can be a vulnerable point and Achilles' heel if not properly ensured between generic and reference listed drugs.
- Quality by Design requires early investment in analytics to characterize reference listed drug variability and identify critical quality attributes.
- Lessons learned are that complex generic and biosimilar development share common challenges in demonstrating equivalence, and asking the right questions with the appropriate tools is important.
Explaining the behavioral economics context of culture of qualityAjaz Hussain
Thank you for the many comments on Pharmaceutical Culture of Quality presentation. Some of you asked for more information to understand why I based the discussion in the context of behavioral economics (as opposed to, for example, ethics). This slide-deck provides an explanation for my decision to link culture of quality to the dimension of econometric and behavioral economics.
Pharmaceutical Quality - The Office ofAjaz Hussain
The keynote address at the Fall meeting of the CPPR Industrial Advisory Board and the Site Directors held yesterday (27 October 2014) at Purdue University. The talk provides a perspective on the recent organizational changes announced by FDA CDER - the Office of Pharmaceutical Quality.
Culture of Quality Bagladesh AAPS 8 August 2015 FinalAjaz Hussain
Why we are discussing Culture of Quality?
What is Culture of Quality?
How can it help?
The American public is facing unprecedented drug shortages and recalls (erosion of confidence)
Industry and the FDA have the shared obligation to reduce quality errors …
To fulfill this responsibility, both industry and the FDA need a culture of quality.
Social Media Megaphone, the new Voice of the Patients. An evolving case example to observe and learn how the pharmaceutical community addresses the needs of ADHD patients and parents.
An opportunity to observe and learn (real time) from this evolving case example. I am eager to to see the reaction (hoping it is that of satisfaction) on social media when FDA reports its findings.
If there are no issues found by FDA; what will be the reaction?
If FDA changes the AB -rating (i.e., interchangeability) - what will be the reaction?
Biopharmaceutics Classification System (BCS) & Waiver of BioequivalenceAjaz Hussain
Graduate Lecture at the University of Maryland (August 2012). Learning Objective: Identify and explain how future regulatory applications of BCS may be realized in the context of ‘Quality by Design’.
Updated July 2013.
I wish to thank all the viewers of my Slideshare presentation of the development and application of the US FDA’s BCS Guidance 2000. Over 11K views have been recorded making this the 2nd highest viewed presentation. FDA is expected to issue a revised BCS draft guidance in the next few weeks. Expected changes include the following:
1. Addition of ‘very rapid’ dissolution criteria (>85% in 15 minutes)
2. Change permeability boundary from 90% to 85%
3. Change the pH solubility range from 1 – 7.5 to 1 – 6.8
4. Possibility of changing paddle speed from 50 to 75 rpm.
5. Additional topics / clarification on FDCs (Fixed Dose Combinations), ODTs (Orally Disintegrating Tablets), MR (Modified Release) products.
6. Update the list of model drugs.
7. Strengthen GI stability requirement.
Data Integrity Validation Keynote Address Boston August 2016Ajaz Hussain
The document provides an overview of a keynote presentation on data integrity and compliance. It discusses evaluating the global regulatory landscape on data integrity expectations, the 2016 FDA draft guidance on data integrity, and overcoming top challenges. It also addresses proactively assuring data integrity and achieving an effective culture of pharmaceutical quality. The presentation examines increasing breaches of data integrity noted in FDA warning letters and inspections globally.
How to Make Awesome SlideShares: Tips & TricksSlideShare
Turbocharge your online presence with SlideShare. We provide the best tips and tricks for succeeding on SlideShare. Get ideas for what to upload, tips for designing your deck and more.
SlideShare is a global platform for sharing presentations, infographics, videos and documents. It has over 18 million pieces of professional content uploaded by experts like Eric Schmidt and Guy Kawasaki. The document provides tips for setting up an account on SlideShare, uploading content, optimizing it for searchability, and sharing it on social media to build an audience and reputation as a subject matter expert.
Current issues and challenges in demonstrating QbD Korea 1 December 2014Ajaz Hussain
2014 Ministry of Food and Drug Safety (MFDS) International Workshop: Quality by Design (QbD) Implementation and Regulatory Challenges in theNew Pharmaceutical Quality ParadigmDecember 1 -2, 2014, Grand Hilton Hotel, Seoul, Korea.
Legitimate pharmaceutical community has practiced QbD for decades; however in ways that vary undesirably.
Demonstration of QbD is multifaceted.
There are serious consequences …in ways that can vary undesirably…
The consequence of “Cheating by Design” are almost always catastrophic.
Perhaps we need to view QbD applications/submissions as an additional layer of protection; to gauge the Culture of Quality.
Legitimate efficiency – is a key business driver, good for the patients, and the society overall.
Proposed ICH Q12: Regulatory Dossier - “regulatory commitments”.
Pharmaceutical Quality System aspects (ICH Q10) – risk and knowledge management system.
Post-Approval Change Management Plans and Protocols.
A reminder of the approach utilized for FDA’s PAT Guidance, Comparability Protocol and Team Approach.
Must focus on integrated implementation.
Team-building and training for Review, Compliance & Inspection functions.
Recognize that QbD Applications/submissions serve as an additional layer of protection; to gauge the Culture of Quality.
This document contains forward-looking statements about ChromaDex's expected sales, financial performance, products, and commercialization opportunities in various markets. It discusses ChromaDex's patented ingredient technologies including NIAGENTM, a nicotinamide riboside ingredient, and PURENERGYTM, a patented combination of pterostilbene and caffeine. The document notes recent regulatory scrutiny of energy drinks and how PURENERGYTM could help reduce caffeine content while maintaining energy benefits. It summarizes ChromaDex's commercialization progress for NIAGENTM including a large supply agreement and initial customer adoption.
The National Association of Pharmaceutical Manufacturers (NAPM) was established in 1977 as A Section 21 Trade Association which. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. The NAPM has a diverse membership comprising of 18 companies. Part of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
Excipient Knowledge Management Mumbai 12 March 2015 Part 1 & 2Ajaz Hussain
Ajaz Hussain discusses the importance of excipient knowledge management, particularly regarding physical functionality and performance. He notes that many drug products now require precise control of complex material attributes supplied by excipients. Effective knowledge management is needed to understand and control excipient variability. Hussain also highlights current regulatory trends and the need to improve databases on inactive ingredients to better track excipient functionality.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
75 min presentation in program organized by Gudia (Pvt.) Ltd Pakistan & Dr. P...Obaid Ali / Roohi B. Obaid
This document summarizes a presentation on pharmaceutical manufacturing given by Roohi B. Obaid. The presentation discusses issues like product recalls due to contamination, the importance of understanding manufacturing processes and their impact on product quality, and establishing a quality culture. It emphasizes having a robust quality system, challenging assumptions, learning from mistakes, and ensuring products meet their intended quality through testing and metrics. The overall goal is consistently delivering safe, effective medicines to patients.
Here are some key facts and figures about the global pharmaceutical industry:
- The global pharmaceutical market was estimated to be worth around $1.2 trillion in 2020. It is projected to reach $1.6 trillion by 2026.
- The top 10 global pharmaceutical companies by revenue in 2020 were Johnson & Johnson, Pfizer, Roche, Sanofi, Novartis, Merck & Co., AbbVie, GSK, Amgen, and Gilead Sciences.
- The top three pharmaceutical markets by sales in 2020 were the US at $360 billion, China at $145 billion, and Japan at $102 billion.
- The US accounted for around 40% of global pharmaceutical spending in 2020, despite
Adherence to the Cuurent Good manufacturing Practices (CGMP) Regulations in t...Obaid Ali / Roohi B. Obaid
The document discusses several key challenges facing the pharmaceutical industry in adhering to CGMP regulations and SOP compliance. It notes that simply trying to meet standards is not enough and that human factors must be considered more closely in designing manufacturing processes using insights from behavioral economics. Industry is often trapped in a "file first, figure it out later" mindset. The document also highlights progress being made in areas like QbD and PAT-based manufacturing that can help address issues if more widely adopted. Overall, it argues the industry must overcome its natural immunity to change by better accounting for human behaviors and designing quality management systems in a more human-centric way.
Opportunities of BDS in Pharmaceutical Industries.pptxDr. Manoj Kumbhare
India is the second-largest pharmaceutical market in Asia. ... A BDS graduate can have various job roles available in this sector: Principal Investigator, Co-investigator, Medical Advisor, Drug Developer, Regulatory Affairs Manager or even a Clinical Research Physician.
Career opportunities in the clinical research field are many and varied, with employment settings ranging from pharmaceutical and biotechnology, to medical device companies, contract research organizations, hospitals, educational institutions, independent contractors and more.
Many professionals with a strong science or healthcare related background — such as nurses, pharmacists, medical technologists, physicians and more — are well-positioned to join the clinical research field. Here are 10 career paths in the field.
This document discusses the need for quality culture and continuous learning in the pharmaceutical industry to cope with evolving regulatory standards. It emphasizes that quality agreements between contract services and product owners guarantee sustainable supply of quality drugs. Understanding systems, managing deficiencies accurately, and adopting systems to deliver better patient care are also highlighted as important in responding to changing needs and designing the future of cGMP, quality systems, and product lifecycles. The event agenda includes presentations on these topics from industry experts.
Mérieux NutriSciences provides laboratory testing, auditing, consulting and other services related to food safety and quality. They have a global network of facilities and have experienced significant growth over the last 5 years. Their new facility in Saudi Arabia will help clients in the Middle East and Africa regions assure food safety and quality across their supply chains through integrated solutions like testing, inspection and certification services. Food safety has become increasingly important to consumers, regulators and businesses operating in Saudi Arabia.
Critical Importance of Pharmaceutical Traceability in the Experience.pdfAjaz Hussain
From a narrow viewpoint, serialization is just a process of printing an identifying number on products and shipping cases.
From a long-term view, the integration of serialization numbering systems with the production line as well as the quality control procedures required to maintain the integrity of the numbers.
From Deming to Orders of ConsciousnessAjaz Hussain
It is very easy to feel “in over our head” in an increasingly complex world. CGMP Regulations (written in 1997) required “education, training or experience”; these regulations need to be updated. Traditional education (e.g., chemistry, pharmacy, etc.) is not adequately preparing students for the demands of the real world. Systems proficiency is a stage in adult development; we must take responsibility for our self-development and support development of others.
“A study on customer feedback and upgradation of Haem up vet launched or intr...Vatsal Patel
A summer internship project on “A study on customer feedback and upgradation of Haem up vet launched or introduced by cadila pharmaceutical as per market needs”
This document summarizes a presentation on quality metrics and culture given at Habib University in Karachi. It discusses key quality metrics like lot acceptance rate, product complaint rate, and CAPA effectiveness. It also identifies attributes of a strong quality culture like leadership emphasis, message credibility, peer involvement, and employee ownership. Finally, it stresses that quality is everyone's responsibility and a mature quality system relies on systems thinking and a culture that prioritizes quality and continuous improvement.
Presenting this set of slides with name - Healthcare Sector Analysis Powerpoint Presentation Slides. Keep your audience glued to their seats with professionally designed PPT slides. This deck comprises of total of sixty four slides. It has PPT templates with creative visuals and well researched content. Not just this, our PowerPoint professionals have crafted this deck with appropriate diagrams, layouts, icons, graphs, charts and more. This content ready presentation deck is fully editable. Just click the DOWNLOAD button below. Change the colour, text and font size. You can also modify the content as per your need. Get access to this well crafted complete deck presentation and leave your audience stunned.
Regulatory compliance is important for the pharmaceutical industry. It refers to adhering to both legal requirements and internal policies. Ensuring compliant and ethical business practices is key. Compliance aims to solve legal issues, ensure safety, and increase demand. It involves oversight from regulatory bodies, industries, and consumers. Pharmaceutical companies must establish procedures, control materials, perform tests, and share data with inspectors to maintain compliance. Following guidelines and rules can help compliance work effectively.
Similar to Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015 (20)
A Leapfrog Need and Opportunity for mAbsAjaz Hussain
Leapfrogging on reforming mAbs policies makes sense, and doing so can be a principled duty of care.
SMART Technology, SMART Professionals, SMART Services, SMART Organization.
SMART Quality by Design Applications Not Submissions in 2024Ajaz Hussain
Many generic pharma companies seeking regulatory approval uncritically follow “past” practices and prior knowledge. Few, if any, correct errors and innovate to improve past expertise and techniques. The idea of SMART "QbD in ANDApplications" (not “submission”) builds on this observation.
Intuitively Moving Institutions Towards Global Regulatory Resilience Ajaz Hussain
From my experience, how can I describe an intuitive and self-organizing social force around "attractors" patients' value to be assured of therapeutic equivalence?
Validation 4 for Credible Pharma 4 a Keynote for Valconnect 2023.pdfAjaz Hussain
The document discusses the concept of "Validation 4.0" in the context of Pharma 4.0. It argues that Validation 4.0 involves transforming old approaches to compliance into a new mindset focused on internal assurance, self-assurance, and authoring validation policies without needing FDA guidance. Validation 4.0 is about developing professionals and ensuring the integrity of their data and experience. The keynote talk will elaborate on Validation 4.0 and providing SMART ways to validate professionals and corporations to make progress in Pharma 4.0 credible.
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdfAjaz Hussain
Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review?
Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.”
What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response?
Statistical Thinking and Pharmaceutical Professional Development, a keynote b...Ajaz Hussain
In adulthood, to keep maturing, one must acknowledge the elephant in the room – the emotions we feel. To feel is to experience. Experience complements our scientific training. But do we pay attention to the Integrity of our experience? A tonic for wiser statistical thinking to inform the development of pharmaceuticals and professionals.
An Updating Perspective on BAD I in March Madness 2023.pdfAjaz Hussain
Why does it take decades to acknowledge the obvious? Something to ponder and write about. How do you suggest we keep moving closer to the truth? Can we simultaneously personalize our minds, machines, and medicines to develop continuously? How? I am sharing a slide deck of thoughts to discuss meaning-making and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the context of the post-truth world, which I collected to populate two invited lectures at the University of Minnesota, College of Pharmacy. The slides I am uploading here are in reverse order, 2nd lecture followed by the first. It is, to begin with, a journey to 2020+ to note that the root cause of BAD-I is I and to pose a challenging premise that beyond the age of majority, few adults continue to develop and mature. What evidence warrants this premise, and why? Then how to develop and mature continuously as an adult and a professional.
Mature Managers and Management of Pharmaceutical Quality and QuantitiesAjaz Hussain
We live in a post-truth world, and we like to think we are good. Are we? Do we not need ALCOA for the integrity of our experience?
Remember: Experience means to feel; how you feel determines what you learn! Honoring my grandmother’s advice, keeping intentions clean, इरादों को साफ रखें to begin to recognize a pattern of interactions between how I feel, what I think to explain why I behaved in a certain way.
Some of my thoughts on SMART Objective negotiations and to be better at SMART Experiencing than SMART Machines. The content describes insights from observing the immaturity of political, regulating, and management systems. Why does “immature” claim “I am mature” when it shouldn't?
I-SMART Internal Validation for Continuous Professional Development.pdfAjaz Hussain
The document discusses Ajaz Hussain's i-SMART framework for continuous professional development and validation lifecycle management. i-SMART stands for internal validation and promotes self-monitoring, analysis, and reporting using technology. It aims to validate individuals' skills and knowledge over their careers through objective measures of their experience and performance. Hussain argues that i-SMART can help ensure the ongoing suitability and capability of professionals by facilitating lifelong learning from their own experiences as well as others'. His prior work developing the [SMART]^3 methodology is also cited as informing the path to an i-SMART approach.
S.M.A.R.T Pharmaceuticals 2021 -2030: AI or Human?Ajaz Hussain
Take a smart “development stance” to prepare for 2022 and beyond, envision your journey to 2030. Spiral high and wide like a migratory bird. Recall, Reflect, Research, Remember, Reset and Rebuild: Recycling necessary but not sufficient.
https://www.linkedin.com/pulse/recall-reflect-research-remember-reset-rebuild-ajaz-hussain-ph-d-/?trackingId=aF5BbJF0T5%2B036rQ7Zw3gA%3D%3D
Sustain and Build a Quality Culture in Today's RealitiesAjaz Hussain
What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems.
Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “...Ajaz Hussain
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”?
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Pharmaceutical Quality in the 21st Century, Current Status of PAT & QbDAjaz Hussain
What we know is not what we implement in practice is the shadow in our development—walking a tight rope across the precipice with an elephant on my back. Is an Elephant on My Back the apt metaphor to replace the Six Blind Men and an Elephant and an Elephant in the Dark?
Meaning making measurement maturity and management mokshaAjaz Hussain
Power without wisdom is a recipe for disaster. “Your problem is not technology. The problem is you. You lack the will to change” (The Day the Earth Stood Still (2008). “I think we need to do some very serious soul searching,” Woodcock (2020). Adequate, well-controlled, qualified by training and experience, fairly, responsibly (FD&C Act). “Only at the precipice do we evolve.” Is this our moment? Profiteers learn to be patient. Exploitation & Exploration: Bottom and Toplines, the ambidextrous. Quality is integral; warrant connects quantitative evidence with claims. Cease dependence on inspection via maturity of self, systems, & societies. You can find the way forward [to maturity] in the heart. Sense within to awaken. Dil Se! By heart.
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
Challenge: As a system or cohort, we can do more to adequately appreciate that “systems” proficiency is a stage in adult development that most struggle to achieve.
Professionals and human experience: Ex[CI]perience Lessons in Excipients Ajaz Hussain
Alone together, civil war, same difference, unbiased opinion, and the "hindsight is always 20/20" feels oxymoronic. What space will excipients occupy in our consciousness in the next decade?
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Ganpati Kumar Choudhary Indian Ethos PPT.pptx, The Dilemma of Green Energy Corporation
Green Energy Corporation, a leading renewable energy company, faces a dilemma: balancing profitability and sustainability. Pressure to scale rapidly has led to ethical concerns, as the company's commitment to sustainable practices is tested by the need to satisfy shareholders and maintain a competitive edge.
Integrity in leadership builds trust by ensuring consistency between words an...Ram V Chary
Integrity in leadership builds trust by ensuring consistency between words and actions, making leaders reliable and credible. It also ensures ethical decision-making, which fosters a positive organizational culture and promotes long-term success. #RamVChary
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
Comparing Stability and Sustainability in Agile SystemsRob Healy
Copy of the presentation given at XP2024 based on a research paper.
In this paper we explain wat overwork is and the physical and mental health risks associated with it.
We then explore how overwork relates to system stability and inventory.
Finally there is a call to action for Team Leads / Scrum Masters / Managers to measure and monitor excess work for individual teams.
Make it or Break it - Insights for achieving Product-market fit .pdfResonate Digital
This presentation was used in talks in various startup and SMB events, focusing on achieving product-market fit by prioritizing customer needs over your solution. It stresses the importance of engaging with your target audience directly. It also provides techniques for interviewing customers, leveraging Jobs To Be Done for insights, and refining product positioning and features to drive customer adoption.
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...dsnow9802
Colby Hobson stands out as a dynamic leader in the residential construction industry. With a solid reputation built on his exceptional communication and presentation skills, Colby has proven himself to be an excellent team player, fostering a collaborative and efficient work environment.
Public Speaking Tips to Help You Be A Strong Leader.pdfPinta Partners
In the realm of effective leadership, a multitude of skills come into play, but one stands out as both crucial and challenging: public speaking.
Public speaking transcends mere eloquence; it serves as the medium through which leaders articulate their vision, inspire action, and foster engagement. For leaders, refining public speaking skills is essential, elevating their ability to influence, persuade, and lead with resolute conviction. Here are some key tips to consider: https://joellandau.com/the-public-speaking-tips-to-help-you-be-a-stronger-leader/
Org Design is a core skill to be mastered by management for any successful org change.
Org Topologies™ in its essence is a two-dimensional space with 16 distinctive boxes - atomic organizational archetypes. That space helps you to plot your current operating model by positioning individuals, departments, and teams on the map. This will give a profound understanding of the performance of your value-creating organizational ecosystem.
Sethurathnam Ravi: A Legacy in Finance and LeadershipAnjana Josie
Sethurathnam Ravi, also known as S Ravi, is a distinguished Chartered Accountant and former Chairman of the Bombay Stock Exchange (BSE). As the Founder and Managing Partner of Ravi Rajan & Co. LLP, he has made significant contributions to the fields of finance, banking, and corporate governance. His extensive career includes directorships in over 45 major organizations, including LIC, BHEL, and ONGC. With a passion for financial consulting and social issues, S Ravi continues to influence the industry and inspire future leaders.