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Mature Management
of Quality and
Quantities
A Generational Perspective
of Ajaz S. Hussain, Ph.D.
3/6/2023
Ajaz | Insights 1
Mature Management
of Quantities to
Assure Quality
A generational system of systems
perspective on controlling
pharmaceutical quantities to assure
quality.
“Immature” should not claim “I am
mature,” but it does!
Be the change you wish to see in
the systems you live and work in.
3/6/2023
Ajaz | Insights 2
My journey to 2020; don’t
trip on your trip to 2030
• A trip is a journey, excursion, an act of
going to a place and returning; and it is also
to catch one's foot on something and
stumble and fall
• To choose wisely, practice SMART
3/6/2023
Ajaz | Insights 3
Prevent tripping on
your trip to 2030
• Negotiate your annual performance &
review objectives smartly; SMARTO
• You are responsible for learning from
your experience; know-how to use
SMARTE
• Use but don’t get used by SMARTM
machines.
• iSMART = [SMARTO] + [SMARTM] +
[SMARTE]
3/6/2023
Ajaz | Insights 4
SMARTO
• Smartly negotiate annual performance
objectives
– Specific to your responsibility (for
preventing errors of commission) in a
system (with prevailing errors of
omission)
– Measurable results, not insults
– Achievable with the resources and
acknowledging common causes
– Realistic fact-of-the-matter common
sense
– Time-bound practical, and pragmatic
3/6/2023
Ajaz | Insights 5
This Photo by Unknown Author is licensed under CC BY
“If I don’t look, there
is no problem,” it is
“FDA Approved” and
“Validated”
How To Break The Pharmaceutical 2-3 Sigma
Barrier (Like Amgen) (pharmaceuticalonline.com)
[2017]
Pharmaceutical “New Prior Knowledge”: Twenty-
First Century Assurance of Therapeutic
Equivalence | SpringerLink [2019]
3/7/2023
Ajaz | Insights 6
SMARTE
To negotiate objectives smartly, first,
you need to feel, i.e., experience
safety and be modest.
Second, analyze your previous
performance by researching and
testing your assumptions.
Combining the first and second
steps makes SMARTE; then, you
must take action to self-author your
objectives in self-transforming ways.
3/6/2023
Ajaz | Insights 7
In Over Our Heads — Robert Kegan | Harvard University Press
SMARTM
• Use but don’t get used by SMARTM
machines; what can a SMARTM do better?
– SMART stands for self-monitoring,
analysis, and reporting technology
– Do you self-monitor your intentions,
thoughts, and feelings?
– It would be best if you did; to remain
relevant in the SMART revolutions.
3/6/2023
Ajaz | Insights 8
Remember: Experience means
to feel; how you feel
determines what you learn!
• On my journey to 2020, I practice self-
monitoring my intentions, thoughts, and
feelings. Not exactly in real-time, but
contemporaneously.
• Honoring my grandmother’s advice, keeping
intentions clean, इराद� को साफ रख� to begin to
recognize a pattern of interactions between
how I feel, what I think to explain why I
behaved in a certain way
• I did it by heart, Dil Se, and discovered,
analogous to ALOCA for data integrity, an
ALCOA for my Experience Integrity
3/6/2023
Ajaz | Insights 9
ALCOA for my
Experience Integrity
• Attributable to my thoughts and feelings
• Legible patterns that allow me to read my
mind
• Contemporaneous notes of patterns in my
thoughts, feelings, and actions/inactions
• Original insights that give meaning to my
experience
• Accuracy with researching and testing
assumptions to keep moving closer to the
truth
3/6/2023
Ajaz | Insights 10
Remember, we live in a
post-truth world
• The Post-Truth World - Why Have We Had Enough Of Experts?
(forbes.com, May 22, 2017)
– The post-truth era has emerged because of several long-
cycle trends that affect how we make sense of the world
around us. The phenomenon even has a name — agnotology,
the study of culturally induced ignorance or doubt. The
implications of agnotology for business and politics are
enormous.
– “The anti-scientific choices made by the U.S. federal
government during the Covid pandemic have damaged the
public health reputation in the people's eyes.” ~ Dr. Jay
Bhattacharya, 28 February 2023, Select Subcommittee on the
Coronavirus Pandemic - United States House Committee on
Oversight and Accountability
3/6/2023
Ajaz | Insights 11
“Immature” should
not claim “I am
mature,” but it does!
4 Life Sciences Lessons from the PAT to
QbD Journey with Integrity of Experience
is how in the post-truth world I live in; I
practice learning objectively from my
subjective experiences
• You are responsible for learning from your
experience; know-how to use SMARTE; use but
don’t get used by SMARTM machines and
negotiate your annual performance & review
objectives smartly; SMARTO
• Remember by heart means Dil Se; it is not just
memorization; it is to feel, to experience, and
learn from experience!
3/6/2023
Ajaz | Insights 12

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Mature Managers and Management of Pharmaceutical Quality and Quantities

  • 1. Mature Management of Quality and Quantities A Generational Perspective of Ajaz S. Hussain, Ph.D. 3/6/2023 Ajaz | Insights 1
  • 2. Mature Management of Quantities to Assure Quality A generational system of systems perspective on controlling pharmaceutical quantities to assure quality. “Immature” should not claim “I am mature,” but it does! Be the change you wish to see in the systems you live and work in. 3/6/2023 Ajaz | Insights 2
  • 3. My journey to 2020; don’t trip on your trip to 2030 • A trip is a journey, excursion, an act of going to a place and returning; and it is also to catch one's foot on something and stumble and fall • To choose wisely, practice SMART 3/6/2023 Ajaz | Insights 3
  • 4. Prevent tripping on your trip to 2030 • Negotiate your annual performance & review objectives smartly; SMARTO • You are responsible for learning from your experience; know-how to use SMARTE • Use but don’t get used by SMARTM machines. • iSMART = [SMARTO] + [SMARTM] + [SMARTE] 3/6/2023 Ajaz | Insights 4
  • 5. SMARTO • Smartly negotiate annual performance objectives – Specific to your responsibility (for preventing errors of commission) in a system (with prevailing errors of omission) – Measurable results, not insults – Achievable with the resources and acknowledging common causes – Realistic fact-of-the-matter common sense – Time-bound practical, and pragmatic 3/6/2023 Ajaz | Insights 5 This Photo by Unknown Author is licensed under CC BY
  • 6. “If I don’t look, there is no problem,” it is “FDA Approved” and “Validated” How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen) (pharmaceuticalonline.com) [2017] Pharmaceutical “New Prior Knowledge”: Twenty- First Century Assurance of Therapeutic Equivalence | SpringerLink [2019] 3/7/2023 Ajaz | Insights 6
  • 7. SMARTE To negotiate objectives smartly, first, you need to feel, i.e., experience safety and be modest. Second, analyze your previous performance by researching and testing your assumptions. Combining the first and second steps makes SMARTE; then, you must take action to self-author your objectives in self-transforming ways. 3/6/2023 Ajaz | Insights 7 In Over Our Heads — Robert Kegan | Harvard University Press
  • 8. SMARTM • Use but don’t get used by SMARTM machines; what can a SMARTM do better? – SMART stands for self-monitoring, analysis, and reporting technology – Do you self-monitor your intentions, thoughts, and feelings? – It would be best if you did; to remain relevant in the SMART revolutions. 3/6/2023 Ajaz | Insights 8
  • 9. Remember: Experience means to feel; how you feel determines what you learn! • On my journey to 2020, I practice self- monitoring my intentions, thoughts, and feelings. Not exactly in real-time, but contemporaneously. • Honoring my grandmother’s advice, keeping intentions clean, इराद� को साफ रख� to begin to recognize a pattern of interactions between how I feel, what I think to explain why I behaved in a certain way • I did it by heart, Dil Se, and discovered, analogous to ALOCA for data integrity, an ALCOA for my Experience Integrity 3/6/2023 Ajaz | Insights 9
  • 10. ALCOA for my Experience Integrity • Attributable to my thoughts and feelings • Legible patterns that allow me to read my mind • Contemporaneous notes of patterns in my thoughts, feelings, and actions/inactions • Original insights that give meaning to my experience • Accuracy with researching and testing assumptions to keep moving closer to the truth 3/6/2023 Ajaz | Insights 10
  • 11. Remember, we live in a post-truth world • The Post-Truth World - Why Have We Had Enough Of Experts? (forbes.com, May 22, 2017) – The post-truth era has emerged because of several long- cycle trends that affect how we make sense of the world around us. The phenomenon even has a name — agnotology, the study of culturally induced ignorance or doubt. The implications of agnotology for business and politics are enormous. – “The anti-scientific choices made by the U.S. federal government during the Covid pandemic have damaged the public health reputation in the people's eyes.” ~ Dr. Jay Bhattacharya, 28 February 2023, Select Subcommittee on the Coronavirus Pandemic - United States House Committee on Oversight and Accountability 3/6/2023 Ajaz | Insights 11
  • 12. “Immature” should not claim “I am mature,” but it does! 4 Life Sciences Lessons from the PAT to QbD Journey with Integrity of Experience is how in the post-truth world I live in; I practice learning objectively from my subjective experiences • You are responsible for learning from your experience; know-how to use SMARTE; use but don’t get used by SMARTM machines and negotiate your annual performance & review objectives smartly; SMARTO • Remember by heart means Dil Se; it is not just memorization; it is to feel, to experience, and learn from experience! 3/6/2023 Ajaz | Insights 12