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.

1. Sustain and Build a Quality
Culture in Today's Realities
Ajaz S. Hussain, Ph.D., Advisor 12/06/2021
KENX’s Computer Software Validation & Software Assurance University

2. Confidential and proprietary. Do not distribute.
Contemporaneous notes
& development stance
• 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
2
Ajaz | Insights
WWW.LINKEDIN.COM/IN/AJAZSHUSSAIN

3. Confidential and proprietary. Do not distribute.
Background • Encountering BAD-I upon returning to Pharma after working
on Tobacco Harm Reduction – with an expanded awareness on
human behavior, and behavioral economics
3 3
Ajaz | Insights

4. Confidential and proprietary. Do not distribute.
Today's Realities: Whose reality?
2020-2030: Totality of Evidence or Totalitarianism?
4
Ajaz | Insights

5. Confidential and proprietary. Do not distribute.
.
Effective error management aims as continuous reform not local fixes. ~
James Reason (Human Error, 1990)
5
Ajaz | Insights

6. Confidential and proprietary. Do not distribute.
Objectives • A "connect-the-dots" framework
of a “fractal” socio-technical
system that controls and assures
pharmaceutical quality
• A S.W.O.T of [our] development &
maturity in today's realities
• A transformative vocabulary to
make sense of culture under
S.M.A.R.T “mandates”
6
Ajaz | Insights
Figure: Tahseen Hussain
culture (n.) a particular society at a particular time and place; values shared by a society; the attitudes and behavior that are
characteristic of a particular social group or organization

7. Confidential and proprietary. Do not distribute.
Trustworthy, reliable, and equivalent, the letter and spirit of FD&C Act, 21 CFR Part 11 and 211: A "connect-the-
dots" framework of a “fractal” socio-technical system to control and assure pharmaceutical quality.
7
Ajaz | Insights

8. Confidential and proprietary. Do not distribute. 8
Ajaz | Insights

9. A S.W.O.T of [our] development
& maturity in today's realities
“Reset” and “build back better” mandates
9

10. Confidential and proprietary. Do not distribute.
“Reset” and
“build back
better”
mandates
• Real-time surveillance, inspections and review to ensure suitability and
capability of processes and personnel to be Good
• Detect and backpropagate errors of omission and commission to “root
cause” and correct and prevent mistakes in the “Borg” and Human culture
• Learn, develop, mature, and improve self, others, tools and systems
continually without [needing a] Warning Letter with SMART goals, tools
and practices
10
10
Ajaz | Insights
Orders of Consciousness. R. Kegan (1994)
HTTPS://WWW.BIOPHORUM.COM/RESOURCE/DIGITAL-PLANT-MATURITY-MODEL/.

11. A transformative vocabulary
to make sense of culture
under S.M.A.R.T “mandates”
Vision 2020+ with lessons in the Process
Analytical Technology (PAT) Initiative
11

12. Confidential and proprietary. Do not distribute.
Mean Meaning Making and
Manufacturing Maturity
A Column by Ajaz Hussian. Pharma Times (India)
• Amidst the COVID-19
pandemonium, we are
advancing, among other
things, “EUA mandates,”
“Quality Management
Maturity pilot,” “preparing
for the SMART Factories of
the future with “regulations
developed in an Industry 2.0
paradigm,” and continuing to
spiral guidance development
ICH Q14 with revision of ICH
Q2
• Let us remember that
Assurance, in and of itself, is
a critical to quality, safety
and efficacy
Sensemaking Symposium, 23-25 October 2001. Command and Control Research Program. Office of the Assistant Secretary of Defense. Final Report.
12
Ajaz | Insights

13. Unpacking
Why (insight), how (advice) and what (solutions)
13
Ajaz | Insights

14. Confidential and proprietary. Do not distribute.
Why (insights)
“Scientific training and experience” to make decisions “fairly and responsibly”: FD&C Act
IQ (on-boarding & orientation), OQ (education & training), PQ (experiential learning): 21 CFR 211.25
14
Ajaz | Insights

15. Confidential and proprietary. Do not distribute.
Why experiential
learning (often
discounted)?
• Experience means to feel, it is subjective, personal; but so is
“quality” and “assurance”
• Scientists are not Popperian falsifiers of their theories
• Evidence that “education and training,” definably necessary, but
not sufficient for becoming a Good Practioner
.
15
Ajaz | Insights
“How Science Works” in Reference Manual on Scientific Evidence, Second Edition. Federal Judicial Center (2000).

16. Confidential and proprietary. Do not distribute.
How (advice)
• Chaos to Continual Improvement: Path to Harmonization.
CPhI Industry Report 2019:
HTTPS://WWW.CPHI.COM/CONTENT/DAM/INFORMA/CPHI/EN/CPHI-
INSIGHTS/HLN19-CPHI%20INSIGHTS-2019-INDUSTRY-REPORT.PDF
.
16
Ajaz | Insights

17. Confidential and proprietary. Do not distribute.
What (solutions):
SMART goals, tools
• CPQ – pQMS: It is normal, easy, and rewarding to
be Good at what we do
• Emphasis and message credibility
• Peer involvement with empowerment
• Pledge
• ABCD – any body can dance
• Knowledge management
• Variation risk management
• Uncertainty management
• Expectation management
• Continuous Professional Development Plan
(suitability & capability ~ fairly and responsibly)
• 1 (1’) Remove fear
• 2 (2’) Expand awareness
• 3 (3’) Mastery via self-authorships
17
Ajaz | Insights

18. Confidential and proprietary. Do not distribute.
Continuous Professional
Development (CPD)
• Integrated design and systems thinking; in practice a major component is
experiential
• Contemporaneous notes of experiences (interaction of thoughts, feeling in the
context of observations and perceptions) provides insights that can be subjected
to reflection and thought experiments to learn (intrapersonal/social)
• Self-authorship of meeting minutes, SOPs, protocols, policies and plans
demonstrating suitability, and capability assessed in performance
.
18
Ajaz | Insights

19. Confidential and proprietary. Do not distribute.
Summary: A culture of SMART
development & maturity
• 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 and improve
• A socio-technical, law & order, system
• Internal validation to external validation
• Compliance with self-authored valid SOPs
• Mandates - today's realities – Industry 4.0
• Taking a development stance
• Sensemaking, from 1st Principles
• Shared understanding of valid evidence
• Self-assurance to deliver assurance to others
19
Ajaz | Insights
BioPhorum Resource - Digital plant maturity model
In Over Our Heads — Robert Kegan | Harvard University Press

20. Confidential and proprietary. Do not distribute.
Summary • A "connect-the-dots" framework
of a fractal socio-technical system
that controls and assures
pharmaceutical quality
• A S.W.O.T of [our] development &
maturity in today's realities
• A transformative vocabulary to
make sense of culture under
S.M.A.R.T “mandates”
20
Figure: Tahseen Hussain
culture (n.) a particular society at a particular time and place; values shared by a society; the attitudes and behavior that are
characteristic of a particular social group or organization
20
Ajaz | Insights

21. SAN FRANCISCO | TAMPA | TORONTO | MUNICH | SCHIPHOL | CHENNAI
valgenesis.com
Thank you!
Ajaz.Hussain@Valgenesis.com