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.
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”?
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.
eBook - Connectivity - Get Connected. Be Interoperable. Start Now.NextGen Healthcare
Not sure if your practice is appropriately connected? Our new eBook, "Get Connected. Be Interoperable. Start Now." will help you understand the nuances of interoperability and connectivity.
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.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
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”?
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.
eBook - Connectivity - Get Connected. Be Interoperable. Start Now.NextGen Healthcare
Not sure if your practice is appropriately connected? Our new eBook, "Get Connected. Be Interoperable. Start Now." will help you understand the nuances of interoperability and connectivity.
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.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
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?
The Innovation Commercialization Process:A Case StudyCheryl Tulkoff
When people think of innovation, they frequently think of the “big idea” or product while overlooking the fact that innovation is really a process.
They think of innovation solely in the creative sense rather than considering the importance or even existence of an innovation methodology.
Countless examples exist of good inventions that never succeeded in the marketplace or failed to live up to expectations while lesser ones thrived.
Many of these failures could have been eliminated through use of an innovation commercialization process.
This presentation describes the process and demonstrates its application through a case study.
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?
“The Most Recommended Pharma & Life Sciences Solution providers in 2021” highlighting the pharmaceutical and healthcare industries help to improving the human health and forwarding life-expectancy one step further.
The 10 Best Performing CEOs to Watch in 2020.” This issue focuses on some best performing CEOs out there who have made a significant mark in the industry.
The 10 best performing ce os to watch in 2020Merry D'souza
Benoit came on board with the strong conviction that the concentration in the Contract Research Organization (“CRO”) market left broad open incredible opportunities to companies capable of showing superior agility than multinational CRO giants whose size and overheads are a handicap for turnaround time optimization purposes.
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.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
A Healthcare Mergers Framework: How to Accelerate the BenefitsHealth Catalyst
Health system mergers can promise significant savings for participating organizations. Research, however, indicates as much as a tenfold gap between expectation and reality, with systems looking for a savings of 15 percent but more likely to realize savings around 1.5 percent.
Driving the merger expectation-reality disparity is a complex process that, without diligent preparation and strategy, makes it difficult for organizations to fully leverage cost synergies. With the right framework, however, health systems can achieve the process management, data sharing, and governance structure to align leadership, clinicians, and all stakeholders around merger goals.
safeMedicate Drug Calculations Learning & Assessment For Nurses_Brochure_202...lizseyi
There is no room for error with drug calculations. Develop and assess your skills with the world's leading resource for healthcare students and practitioners.
The 10 most impactful healthcare solution providers of 2019Mirror Review
In the magazine, “The 10 Most Impactful Healthcare Solution
Providers of 2019,” we have featured the companies which are helping
the industry to become smarter and more efficient by providing their
out-of-the-box solutions and services. These companies include,
Camomile Healthcare Ventures, Canadian Plasma Resources,
Conversa Health, and Medbelle. We have also explored how these companies are benefiting the various parts of the pipeline.
https://www.mirrorreview.com
https://blog.mirrorreview.com
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.
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.
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We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
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?
The Innovation Commercialization Process:A Case StudyCheryl Tulkoff
When people think of innovation, they frequently think of the “big idea” or product while overlooking the fact that innovation is really a process.
They think of innovation solely in the creative sense rather than considering the importance or even existence of an innovation methodology.
Countless examples exist of good inventions that never succeeded in the marketplace or failed to live up to expectations while lesser ones thrived.
Many of these failures could have been eliminated through use of an innovation commercialization process.
This presentation describes the process and demonstrates its application through a case study.
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?
“The Most Recommended Pharma & Life Sciences Solution providers in 2021” highlighting the pharmaceutical and healthcare industries help to improving the human health and forwarding life-expectancy one step further.
The 10 Best Performing CEOs to Watch in 2020.” This issue focuses on some best performing CEOs out there who have made a significant mark in the industry.
The 10 best performing ce os to watch in 2020Merry D'souza
Benoit came on board with the strong conviction that the concentration in the Contract Research Organization (“CRO”) market left broad open incredible opportunities to companies capable of showing superior agility than multinational CRO giants whose size and overheads are a handicap for turnaround time optimization purposes.
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.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
A Healthcare Mergers Framework: How to Accelerate the BenefitsHealth Catalyst
Health system mergers can promise significant savings for participating organizations. Research, however, indicates as much as a tenfold gap between expectation and reality, with systems looking for a savings of 15 percent but more likely to realize savings around 1.5 percent.
Driving the merger expectation-reality disparity is a complex process that, without diligent preparation and strategy, makes it difficult for organizations to fully leverage cost synergies. With the right framework, however, health systems can achieve the process management, data sharing, and governance structure to align leadership, clinicians, and all stakeholders around merger goals.
safeMedicate Drug Calculations Learning & Assessment For Nurses_Brochure_202...lizseyi
There is no room for error with drug calculations. Develop and assess your skills with the world's leading resource for healthcare students and practitioners.
The 10 most impactful healthcare solution providers of 2019Mirror Review
In the magazine, “The 10 Most Impactful Healthcare Solution
Providers of 2019,” we have featured the companies which are helping
the industry to become smarter and more efficient by providing their
out-of-the-box solutions and services. These companies include,
Camomile Healthcare Ventures, Canadian Plasma Resources,
Conversa Health, and Medbelle. We have also explored how these companies are benefiting the various parts of the pipeline.
https://www.mirrorreview.com
https://blog.mirrorreview.com
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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.
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.
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
i-SMART: Internal validation [is] continuous [professional development]. It is a journey within and without. In the growing chaos, it is urgent and essential that we must be the change we seek in the world. Be I-SMART! #Validaiton #good
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.
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Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
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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.
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
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.”
Industrial Policy and NIPTE: Goodbye NIPTE Ajaz Hussain
1. Grab a chair when the music stops
2. Formulate Pharmaceutical Science Evidence in the Real-World
3. Personalize consequence of the systemic, harmful, societal underappreciation of pharmaceutics, industrial pharmacy, and pharmaceutical engineering
4. I am off to find a jungle to write my first novel
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In its 19th century origin, the current US pharmaceutical regulatory system underestimates the inherent complexity in making pharmaceutical products. Recurring errors, shortages, and warning letters serve as a “red flag,” reminding us that some assumptions we hold as “truths to be self-evident” are not. From an oxymoron to a discipline, pharmaceutical regulatory science is unfolding a fascinating journey from chaos to continual improvement.
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HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
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Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
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Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
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"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Taurus Zodiac Sign_ Personality Traits and Sign Dates.pptxmy Pandit
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Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
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Validation 4 for Credible Pharma 4 a Keynote for Valconnect 2023.pdf
1.
2. Ajaz | Insights for ValConect 2023 2
VALIDATION 4.0 MAKES
PHARMA 4.0 CREDIBLE
The notion of Validation 4.0 in the title of this keynote relates to
the development and maturity of people and professionals,
which I will elaborate on in the context of the ValGenesis
experience of its users and service providers.
I wish to acknowledge and appreciate some of the ongoing
efforts at the International Society for Pharmaceutical
Engineering to dialogue, roadmap, and provide practical
guidance for Pharma 4.0™
Among other things, Pharma 4.0 is envisioned to encompass
the notions of a SMART [Pharmaceutical] Factory in the context
of the Industry 4.0 revolution accelerating outside the pharma
sector.
To succeed in this endeavor, we need to transform our old ways
of approaching compliance to a new mindset and, to do so,
break with tradition and lay a new foundation for validation,
“Validation 4.0,” which also is a core operational topic of
discussion and practical guidance within the ISPE community.
Validation 4.0 in this talk is about internal assurance, self-
assurance, and self-authoring policies, plans, and procedures,
ideally without the need [to wait] for FDA guidance.
3. Ajaz | Insights for ValConect 2023 3
MY ATTENTION IS ON
PROFESSIONAL DEVELOPMENT AND
SYSTEM MATURITY.
I draw inspiration from the Hermetic principle "As Above, So
Below - As Within, So Without" to consider the chaotic and
complex characteristics of socio-technical systems in which
we live and work.
I observe, make sense of, and seek a deeper understanding
of ways to empower minds in chaos to manage materials,
machines, and money.
In my understanding, I will elaborate on Validation 4.0 and
share some insights on SMART ways to achieve internal and
external validation of “people" and "professionals" in their
various roles and responsibilities, ensuring the integrity of
their data and experience.
In this sense, the title of my talk reads, Validation 4.0 of
professionals and corporations makes progress in Pharma
4.0 credible! This talk builds on a blog post I wrote many
years ago, Education, Training, Experience & 21 CFR 211.25:
Theory, Practice and Epistemology.
5. “Built for modern
validation.”
But we live in a
post-modern, post-
truth world in an
experience
economy!
Validation 4.0
makes Pharma 4.0
credible.
Sustain and Build a Quality Culture in Today's Realities. KENX’s Computer Software Validation & Software Assurance University, (December 2021)
6. PAY AT T E N T I O N TO U X A N D V X .
WHEN
EXPERIENCE
MATTERS MORE
Validation 4.0
(IQ, OQ, PQ & CPV for Valid Experience)
Note: The genesis of “validation” stems from our need to control, and it evolves under the influences of our
“desires” and opinions. In a rule-based society, it is also a legal (mandate. In modernity, evidence-based practices
are highly valued, and impartial inspections confirm adherence to them. As a system matures and consistently
exhibits confident internal validation, its offerings create the sense of security we require, and the necessity for
external audits decreases and may even become discretionary, depending on an adequate level of objective risk
management. ValGenesis can be a SMART solution in this socio-technical context
Ajaz | Insights for ValConnect 2023
6
7. Ajaz | Insights for ValConect 2023 7
MANY [NEW] ASSOCIATES, ONE QUALITY VOICE?
HOW WE OPTIMALLY LEVERAGE DIVERSITY TO IMPROVE UX AND SX
8. MY VIEWPOINTS
Academia (1986-1994)
US FDA (January 1995-October 2005)
Advisor ValGenesis (November 2005- present)
Global Head Biosimilar Development, Sandoz/Novartis
CSO & VP Next Generation Products, Philip Morris
International
CSO President Biotechnology, Wockhardt, Ltd.
Insight Advise and Solutions, LLC
President National Institute for Pharmaceutical Technology
& Education
Presently advisor at ValGenesis and others such as Applied
SmartFactory, and CONTINUUS Pharmaceuticals, ….
The Nation Needs a Comprehensive Pharmaceutical Engineering Education and Research System (September 2005) (ISPE.org)
4 Life Sciences Lessons from the PAT to QbD Journey (Valgenesis.com)
Ajaz | Insights for ValConect 2023 8
Assuring “integrity of
experience.” A personal
VLMS perspective.
9. 4 Life Sciences Lessons from
the PAT to QbD Journey
(Valgenesis.com)
Hone Quality through Research
before and after “approval.”
Education and Training Alone Cannot Overcome
Displacement by AI, Experience Integrity Matters
Facilitating Adult Human Development Empowers
Our SMART Future
Continual Professional Development is Essential
10. Seek a holistic view from different viewpoints:
Practice transitioning from intricate details to the bigger picture and vice versa. Get good (=
valid) at doing so effortlessly and with seamless precision.
11.
12. A legacy of lingering errors of omission
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004
13. SMART MINDS
SMART machines, materials, and
money aligning with critical
[Pharma] 4.0 directional vectors
The FD&C Act (1938), CGMP Regulations, and
“Predicate rule” (Part 11)
Scientific training and experience to assess
evidence of “substantial effectiveness” fairly
and responsibly (Kefauver Harris Amendment,
1962)
21 CFR § 211.25 Personnel qualifications –
“education, training [and] experience”
Legacy, responsibility to adhere to and improve
In Over Our Heads — Robert Kegan | Harvard University
BioPhorum Resource - Digital plant maturity model
14. Ajaz | Insights for ValConnect 2023 14
HOW TO BREAK THE PHARMACEUTICAL 2-3 SIGMA BARRIER (LIKE
AMGEN) (PHARMACEUTICALONLINE.COM) 2017
15. “One Quality Voice” amidst variable qualia, systems
maturity, and quality culture.
FDA’s White Paper (2015): One Quality Voice and CDER’s Quality Management Maturity (QMM) Program (August 2023 update)
16. Ajaz | Insights for ValConect 2023 16
DON’T FORGET THE LEGACY OF “FDA
APPROVED,” VALIDATED PROCESS!
• “Doing more is recognizing that our systems
are socio-technical systems. [System] maturity
is our maturity, to be suitable and capable of
moving from “don’t use and don’t tell” and “if I
don’t look, there is no problem” and “fail and
fix” to be able to “predict and prevent” harm.”
Pharmaceutical Quality, Team Science, and Education
Themes: Observations and Commentary on a Remarkable
AAPS PharmSciTech Theme Issue | SpringerLink (4 March
2021)
• “A grain of wise subjectivity tells us more
about the real world than any amount of
objectivity.” ― Judea Pearl, The Book of Why:
The New Science of Cause and Effect (2018)
“Root cause unknown” can point
to legacy “common causes”
To critically risk assess “common cause
variations,” make “common sense.”
Physicochemical failure modes for Narrow Therapeutic Index (NTI) drugs (europeanpharmaceuticalreview.com)
17. Ajaz | Insights for ValConect 2023 17
HOW TO MAKE COMMONSENSE GOOD?
• Expand and share awareness to make sense in
a way that bridges the differences in
understanding
• Do so with the integrity of experience!
• Note that understanding is shared more
efficiently within a technical discipline (a
downside of ‘group think” poses a risk of
shared biases) than across disciplines; shared
sensemaking to mind the gaps fairly and
responsibly generates Team Science.
• In Team Science, we ask questions that induce
critical thinking without criticism, scientific
questions, not scientism
Validate sensemaking process? VLMS for good sensemaking
Adapted from Dennis K. Leedom. Final Report, Sensemaking Symposium, October 2001. Command and Control Research
Program, Office of the Assistant Secretary of Defense, for Command, Control, Communications, and Intelligence.
18. PHARMACEUTICAL “NEW PRIOR KNOWLEDGE”:
TWENTY-FIRST CENTURY ASSURANCE OF
THERAPEUTIC EQUIVALENCE | AAPS PHARMSCITECH (SPRINGER.COM)
• [A] No ANDA has been submitted for 10% of all FDA-
approved NDAs (100%) despite expired patents and
exclusivities.
• [B] Quoting an FDA-issued Federal Register notice—
“The drugs described in more than half of all FDA-
approved ANDAs are never marketed, marketed
only after a substantial delay after approval, or
marketed only intermittently. Such failures to
market contribute to drug shortages and hinder
consumer access to approved products.”
• [C] Percentage of approved and commercialized
ANDA’s
Ajaz | Insights for ValConect 2023 18
19. Ajaz | Insights for ValConect 2023 19
VALGENESIS: A SMART SOLUTION
CRITICAL WITHOUT CRITICISM, SCIENTIFIC, NOT SCIENTISM
• I am eager to learn about the ValGenesis user
experience at Valconnect 2023 and learn what the
ValGenesis UX Research Team is up to now
• Dexcom’s experience migrating from a paper-based
system
• The story of using the Project Module in ValGenesis
VLMS to manage all validation deliverables for
projects and changes at Cardinal Health.
• Other experiences
• Satisfying individual needs and aspirations for
continual improvement, development, and
maturity
• Satisfying continual improvement,
development, and maturity of the VLMS
platform
• Satisfying aspirations of ValGenesis
development and maturity to remain a de facto
VLMS standard in life science
Satisfying UX Satisfying VX
20. VALGENESIS SMART
• Machines: Self-monitoring, analyzing and reporting
technologies
• Minds: Self-monitoring, analyzing, researching, and
testing [to detect and correct errors of omission]
• Integrating SMART machines and minds is crucial to
managing material variability and for the credibility
of efforts and outcomes while navigating in reality
with a Pharma 4.0 roadmap
• Attention to the integrity of UX and SX necessary
for Validation 4.0
• Validation 4.0 personally is self-assuring valid
sensemaking via self-authoring, making internal
validation normal, easy, and rewarding
• Externally, VLMS 4.0 opened the door to ValGenesis
SMART; now VLMS 4.2 helps place critical thinking
upfront and move towards an improved scientific
basis for risk management
SMART dimensions Validation 4.0 ([n the context of] Pharma 4.0
Ajaz | Insights for ValConect 2023 20