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.

1. Beware of assumptions that seem "obvious" in one
decade. They may become quaint in the next.
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"Self-awareness is probably overrated. A complex, self-regulating system doesn't need it to be successful, or even smart.“ David Brin
2022 2022
The Gold Sheet 28 March 2014
BAD-I and Confronting the
Illusions of Quality (1937 to 2022):
Rx i-SMART

2. Writing, self-
authorship, an i-
SMART technology
• Hussain, A.S., Process Analytical Technology (PAT): Understanding Validity of Pharmaceutical Quality Control and
Assurance. In Handbook of Validation in Pharmaceutical Processes (pp. 883-915). CRC Press (2021)
• Hussain, A.S., Morris, K. & Gurvich, V.J. Pharmaceutical Quality, Team Science, and Education Themes:
Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue. AAPS PharmSciTech 22, 88
(2021). https://doi.org/10.1208/s12249-021-01970-7
• Hussain, A. S. Digitization in Pharma and Digital Therapeutics: A Migratory Birds Eye View for Charting a Path
Forward. Pharma Times, 20(12), December 2020. https://ipapharma.org/3d-flip-book/pharma-times-december-
2020/
• Gurvich, V.J., Hussain, A.S. In, and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering
Community Must Engage to Meet Critical National Needs. AAPS PharmSciTech 21, 153 (2020).
https://doi.org/10.1208/s12249-020-01718-9
• Hussain, A. S. Pharmaceuticals Beyond 2020: Professionals and Artificial Intelligence. Indian Pharmaceutical
Association. Pharma Times. 52: 14- 19 June 2020. https://ipapharma.org/3d-flip-book/pharma-times-june-2020/
• Hussain, A.S., Gurvich, V.J. & Morris, K. Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance
of Therapeutic Equivalence. AAPS PharmSciTech 20, 140 (2019). https://doi.org/10.1208/s12249-019-1347-6
• Hussain, A.S. Chaos to Continual Improvement: Path to Harmonization. CPhI Industry Report 2019:
https://www.cphi.com/content/dam/Informa/cphi/en/cphi-insights/HLN19CPhI%20Insights-2019-Industry-
Report.pdf
• Hussain, A. S. How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen). Pharmaceutical Online.
September 18, 2017. https://www.pharmaceuticalonline.com/doc/how-to-break-the-pharmaceutical-sigmabarrier-
like-amgen-0001
• Hussain, A. S. Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century? Pharmaceutical
Online. Guest Column | September 22, 2016. https://www.pharmaceuticalonline.com/doc/compliance-or-
adherence-how-to-approachcgmp-regulations-in-the-st-century-0001
• Hussain, A.S. The culture of Pharmaceutical Quality: Personnel Development. Biopharma Asia
March/April 2016; The culture of Pharmaceutical Quality Management System. Biopharma Asia
November/December 2015, and The culture of Pharmaceutical Quality: Connecting the Dots. Biopharma Asia
34-38. Issue September/October 2015
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3. Aj az S . H u s s ai n , P h .D.
i-SMART: Internal Validation for Continuous
Professional Development & Validation Life-cycle
Management
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4. Title: A heading, a brief summary of the matters it
deals with, [a legal document, an appellation, ..]
SMART Acronym (objectives, technology); smart: elegant, stylish, quickness and ease of learning, alertness, resourcefulness, etc
Internal Within an individual, technology, and corporation
Validation To recognize or affirm the validity or worth of a person, their feelings, and opinions; declare legal [Good], prove the accuracy
Continuous Without interruption [subtly different from continual; regularly recurring in a series]
Professional One who declares to be skilled in a specific occupation (an activity that occupies a person's attention)
Development The act of improving by expanding, enlarging, and refining
Life-cycle To go through a recurring sequence in the course of existence and experience of being alive
Management Actions to achieve a goal, objectives, results
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5. [S.M.A.R.T]^3
• Specific, Measurable, Achievable, Realistic, and Time-bound
Management
• Self-Monitoring, Analysis, and Reporting Technology
Machines
• Safe, Modest, Actionable Research and Testing [assumptions, beliefs, etc.]
Man [living human beings]
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6. Scientific training and Experience (FD&C Act) and Education, Training or
Experience (21 CFR 211.25): Suitable [Maturity] and Capability [Development]
to Assure Effectiveness Fairly and Responsibly: [SMART]^3
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7. Guidance, know-how and how do you know?
Theory to Practice [ of
Industrial Pharmacy] &
Observations to
Development
Regulatory guidance
documents, a
collection of
“consensus” or least
common denominator
Technical information
and know-how
(education & [practical]
training)
Adaptive learning
(learning [on the job]
from experience, self,
and others)
Don follow “the science.” Validate the scientific method in your practice!
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8. Fake it till you make it is not Good
To Err is Human, IOM (1999)
[CPD], Redesigning Continuing Education in the Health
Professions |The National Academies Press (2010)
A Design Thinking, Systems Approach to Well-Being Within
Education and Practice: Proceedings of a Workshop |The
National Academies Press (2018)
Medical errors third-leading cause of death in America
(cnbc.com) (2018)
Physicians experience imposter syndrome more often than other
U.S. workers | News Center | Stanford Medicine (2022)
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9. Cascading objectives, errors of omission &
commission and the experienced “fractal”
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Effective error management aims at continuous reform, not local fixes. ~ James Reason (Human Error, 1990)

10. Education and training: Installation Qualification (IQ)
Theory and Practice [of
Industrial Pharmacy]
“Observation to
Development”
Years on the job a
good measure of
experience?
How to measure
experience
(objectively)?
Suitability
capability? OQ, PQ, CPV, Continual Improvement, and Continuous Development,
SMART objective, annual performance, and product review and reports.
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11. Validating subjective experience objectively
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12. i-SMART: Internal validation [is] continuous
development
Safe Modest Actionable Research Test
Seeking external validation to self-assurance
Unmet cascaded objectives OOS
Root cause
[unknown]
Why, why, …
To recognize or affirm the validity or worth of a person,
their feelings, and opinions (1); declare legal [Good] (2);
prove the accuracy (3).
Feeling If I don’t look, there is no problem! P-D-C-A
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13. Feeling Good: Looking, Being, Doing, and Seeing
Mean Meaning Making and Manufacturing Maturity | A Column by Ajaz Hussian, Pharma Times (Nov. 2020)
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14. i-SMART: A journey within and without
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Self-authorship (contemporaneous notes)
Why
How
What

15. Maturing is knowing and changing feelings
How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen) (pharmaceuticalonline.com) (September 18, 2017)
P-D-C-A
Feeling
Experience: an emotional sensation (feeling), firsthand knowledge of states, situations, emotions, and sensations
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16. Practical: Learning from [Others] Experience
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17. Recalls were the result of the companies’ own test!
“Butterfly effect.” Does it make sense?
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Sensemaking Symposium, 23-25 October 2001. Command and Control Research Program. Office
of the Assistant Secretary of Defense. Final Report.

18. Good Culture of Pharmaceutical Quality to Maturity
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19. In the growing chaos, it is urgent and essential that we
must be the change we seek in the world. Be i-SMART!
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4 Life Science Lessons from the PAT to QbD Journey, May 2022
1: Professional Development Is Essential
2: Development Empowers Our SMART Future
3: Education and Training + Adaptive Learning
4. Care is Research, Wisdom is in Practice

20. [SMART]^3 a path
to i-SMART
• Hussain, A.S., Process Analytical Technology (PAT): Understanding Validity of Pharmaceutical Quality Control and
Assurance. In Handbook of Validation in Pharmaceutical Processes (pp. 883-915). CRC Press (2021)
• Hussain, A.S., Morris, K. & Gurvich, V.J. Pharmaceutical Quality, Team Science, and Education Themes:
Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue. AAPS PharmSciTech 22, 88
(2021). https://doi.org/10.1208/s12249-021-01970-7
• Hussain, A. S. Digitization in Pharma and Digital Therapeutics: A Migratory Birds Eye View for Charting a Path
Forward. Pharma Times, 20(12), December 2020. https://ipapharma.org/3d-flip-book/pharma-times-december-
2020/
• Gurvich, V.J., Hussain, A.S. In, and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering
Community Must Engage to Meet Critical National Needs. AAPS PharmSciTech 21, 153 (2020).
https://doi.org/10.1208/s12249-020-01718-9
• Hussain, A. S. Pharmaceuticals Beyond 2020: Professionals and Artificial Intelligence. Indian Pharmaceutical
Association. Pharma Times. 52: 14- 19 June 2020. https://ipapharma.org/3d-flip-book/pharma-times-june-2020/
• Hussain, A.S., Gurvich, V.J. & Morris, K. Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance
of Therapeutic Equivalence. AAPS PharmSciTech 20, 140 (2019). https://doi.org/10.1208/s12249-019-1347-6
• Hussain, A.S. Chaos to Continual Improvement: Path to Harmonization. CPhI Industry Report 2019:
https://www.cphi.com/content/dam/Informa/cphi/en/cphi-insights/HLN19CPhI%20Insights-2019-Industry-
Report.pdf
• Hussain, A. S. How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen). Pharmaceutical Online.
September 18, 2017. https://www.pharmaceuticalonline.com/doc/how-to-break-the-pharmaceutical-sigmabarrier-
like-amgen-0001
• Hussain, A. S. Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century? Pharmaceutical
Online. Guest Column | September 22, 2016. https://www.pharmaceuticalonline.com/doc/compliance-or-
adherence-how-to-approachcgmp-regulations-in-the-st-century-0001
• Hussain, A.S. The culture of Pharmaceutical Quality: Personnel Development. Biopharma Asia
March/April 2016; The culture of Pharmaceutical Quality Management System. Biopharma Asia
November/December 2015, and The culture of Pharmaceutical Quality: Connecting the Dots. Biopharma Asia
34-38. Issue September/October 2015
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