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.

1. Keynote (Synonyms: centerpiece, core, crux,
essence, gist, heart, pivot, point, bottom line, …)?
Ajaz S. Hussain, Ph.D.
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
1
?

2. Summary: PAT Leading to Pharma 4.0 or Vice Versa
• Industry 4.0 and Pharma 4.0 in theory
and practice, what's the difference?
• Overview of the PAT initiative and
lessons in its trials and tribulations
• Pharmaceutical manufacturing the
next decade
• Thriving Strategies and Tactics:
Corporate and Professional
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
2
Cease dependence on inspection via maturity of self, systems, & societies.

3. PAT Leading to Pharma 4.0,
or Vice Versa?
• Ensure is to warrant
• Quality is an experience
• So, what is “Right”
• Design?
• Analytical Process?
• On the flip..
• If “Right” is right, is the
“Left” wrong?
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
3
Quality is integral, warrant connects quantitative evidence with claims.

4. Left is not wrong
when Right is right!
• Without “regulations,” we know
(prior knowledge)
• Profiteers thrive on addicting the
public, e.g., opium traders, “snake
oil salesman," tobacco, internet
Apps,..
• Technology innovation is
exponential – Industry 4.0 now a
political force – “The Great Reset”
• PAT ↔Pharma 4.0 holds lessons
for “the Great Rest;” left is not
wrong when right is right!
• Industry 4.0 and Pharma 4.0 in
theory and practice, what's the
difference?
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
4
Iain McGilchrist. The Master and His Emissary: The Divided Brain and the Making of the Western World
Exploitation & Exploration: Bottom and Top lines, the ambidextrous.

5. A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
5
PAT Leading to Pharma 4.0,
or Vice Versa?
𝑃𝑃𝑃𝑃𝑃𝑃 ↔ 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 4.0
𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼 3.0 ↔ 𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼𝐼 4.0
PAT & RTRT
Pharmacopoeias and Guidance
Implementation of NIR
QbD to Continuous Process Improvement
On demand
Technology Transfer
PAT API
Current Status
(Bio)pharmaceutical
Risk in DOE
CM and Cost & Quality
CPV
Gap between Industry and Academia
Overview of the PAT initiative and lessons in its trials and tribulations
“Your problem is not technology. The problem is you. You lack the will to change.”

6. A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
6

7. By design, take a
system of systems
approach
• Mitigate workforce disruption
• Remove fear of data sharing abound
• Support inclusive technology adoption
• Prepare to navigate disruptions in
global supply and value chains
• Leverage, not exploit, sustainable
production as a competitive
advantage
4 / 1 9 / 2 0 2 1
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
7
Transformation Map – interactive version available online via
https://intelligence.weforum.org Profiteer learns to be patient

8. “Cease dependence on inspection to achieve quality. Eliminate
the need for massive inspection by building quality into the
product in the first place.” ~ Deming
• Pharmaceutical manufacturing
the next decade
• From “Warp Speed” to “real-time”
• Measuring & regulating
“Maturity”
• Rolling “reviews” & virtual reality
of “inspections”
• PAT Guidance to [ICH Q14 (Q2R)]
• Continual to Continuous: Real-time
in PAT Guidance Vs. RTRT
• Validation: Internal and External
• Measurement Uncertainty:
Pharmacopeia Vs. NIST (NIR for
“testing to document” vs control)
4 / 1 9 / 2 0 2 1
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
8
Meaning of measurement maturity and management moksha.

9. We needed to be self-authored to be able
to overcome our “immunity to change”
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
9
How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen) (pharmaceuticalonline.com)
Thriving Strategies and Tactics: Corporate and Professional
“I think we need to do some very serious soul searching,” Woodcock (2020)

10. A J A Z | I N S I G H T S O N " E N S U R I N G Q U A L I T Y W I T H R I G H T D E S I G N &
A N A L Y T I C A L P R O C E S S " 4 / 1 9 / 2 0 2 1 10

11. A prescription is for patients:
Now we all are patients
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
11
HTTPS://WWW.SLIDESHARE.NET/A2ZPHARMSCI/WISER-TODAY-THAN-I-WAS-YESTERDAY-REPEAT
Power without wisdom is a recipe
for disaster. Care is Research,
Knowledge is Power, and Wisdom
is in Practice.

12. A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
12
We're blind to our blindness. We have very little idea of how
little we know. We're not designed to know how little we know.
Daniel Kahneman

13. A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
13

14. A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
14

15. We are good & evil integrated in a
system that is as good or as bad as our
dominant personal reality
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
15
Adequate, well-controlled, qualified by training and experience, fairly, responsibly (FD&C Act)

16. 4 / 1 9 / 2 0 2 1
A J A Z | I N S I G H T S O N " E N S U R I N G Q U A L I T Y W I T H
R I G H T D E S I G N & A N A L Y T I C A L P R O C E S S " 16

17. The ‘master’ is the brain's
right hemisphere and the
‘emissary’, the left.
• The fabric of the world is becoming
fabricated, such that even the mirror ‘of
nature’ no longer appears natural to us.
• The master has been ever more betrayed by
its emissary, especially over the last 200
years.
• By design is our intention – integrated
design and systems thinking, the left is not
wrong when right is right!
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
17
Dil Se! By heart.

18. Summary: PAT Leading to Pharma 4.0 or Vice Versa
• Industry 4.0 and Pharma 4.0 in theory
and practice, what's the difference?
• Overview of the PAT initiative and
lessons in its trials and tribulations
• Pharmaceutical manufacturing the
next decade
• Thriving Strategies and Tactics:
Corporate and Professional
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
18
“Only at the precipice do we evolve.” Is this our moment?

19. Keynote: Power without wisdom is a recipe for
disaster. You can find the way forward [to
maturity] in the heart. Sense within to awaken
and attend this workshop Dil Se!
A
J
A
Z
|
I
N
S
I
G
H
T
S
O
N
"
E
N
S
U
R
I
N
G
Q
U
A
L
I
T
Y
W
I
T
H
R
I
G
H
T
D
E
S
I
G
N
&
A
N
A
L
Y
T
I
C
A
L
P
R
O
C
E
S
S
"
4 / 1 9 / 2 0 2 1
19
Care is Research, Knowledge is
Power, and Wisdom is in
Practice .
Journal of Palliative Care. 2021;36(1):7-8. doi:10.1177/0825859720941972