This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
During the session I would like to bring basic concepts about the performance testing and highlight the activities,
that we are running in CTCo. I believe, that primary audience for this session
would be test engineers, that do not have experience in this activity and would like to gain some knowledge in this area.
Dr Jeff Borden, Director of the Center for Online Learning,
Vice President of Instruction & Academic Strategy, Pearson eCollege, Denver
Presentation at 'Online and open access learning in HE: MOOCs, new pedagogies and business models' conference (5 February 2013, Senate House, London).
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.
In this session from the Institute of Validation Technology's Validation Week Europe, Kurtis Epp and John Kandl discuss how to implement QbD to all three stages of process validation.
This session from the Institute of Validation Technology's Contamination and Control Week discusses regulatory expectations and industry drivers for aseptic cleaning and environmental monitoring, regulatory expectations for cleanrooms, and current FDA and EU expectations during inspection of sterile and aseptic operations.
In this presentation from the Institute of Validation Technology's Life Sciences Aseptic Processing, Kim Van Antwerpen discusses collecting environmental data, methods for trending, and interpreting and sharing environmental monitoring data.
Regulatory inspections have had a significant impact on the number of drug shortages and companies facing adverse regulatory actions.
Review of the inspection trends can be useful in assessing the regulatory status of your own company and help aid in the preparation for upcoming inspections. This session from IVT's Contamination and Control Week provides an in-depth, practical look at some of the recent Warning Letters and discusses current trends.
The Validation Master Plan is a a valuable opportunity to provide an overview of your company’s validation process, including organization structure, content, and planning.
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a manufacturer's gap analysis.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
This presentation from IVT's 2nd Annual Validation Week Canada covers the 2011 FDA Process validation and the subsequent statistical processes. Statistics in process validation is introduced as well as the integration with six sigma and solutions to common mistakes.
A comprehensive presentation on GMP systems and integration. This includes validations, vendor qualification, preventative maintenance, audits, CAPA, and utilization of system results.
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications. It also covers dosage form considerations and specifications for other components.
This presentation from the Institute of Validation Technology's 7th Annual Method Validation covers regulatory expectations for deviations and out-of-specification results and protocol exceptions, change control, handing investigations and CAPAs, and avoiding common pitfalls.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
1. Validation Exceptions – Managing
life’s little (and big) unexpected events
( g) p
Brian K. Nunnally, Ph.D.
2. What is an exception?
p
An error or a failure which occurs during
Verification or Validation
William Shakespeare: "It is neither good nor
bad, but thinking makes it so."
3. Types of Exceptions
yp p
Three levels of exceptions:
Critical
Non-critical
N iti l
Simple
4. Simple Exceptions
p p
Simple exceptions are documentation or
protocol errors
These errors are found prior to execution or are
Th f d i t ti
“obvious” errors or typos
These e ceptions ha e no impact on the
exceptions have
validation (e.g. no risk)
5. Simple Exceptions examples
p p p
Wrong test selected for product
Incorrect specification for product
Loss of power to the equipment being
tested.
Other examples from the participants?
6. Non-critical Exceptions
p
Non-critical
Non critical exceptions are errors in the
protocol or execution of the validation which
have no impact on the validation
These errors are found during or after execution
Assessment is needed t d t
A ti d d to determine no i
i impactt
Need to document the risk (or lack thereof)
7. Non-critical Exceptions
examples
l
Operator not trained to perform the operation
An interruption in the computer system or
the
th equipment’s performance
i t’ f
Other examples from the participants?
8. Critical Exceptions
p
Critical exceptions are errors which have an
impact on the validation
These errors are found during or after execution
Th f dd i ft ti
Assessment is used to determine impact
Need to document th risk
N dt d t the i k
9. Critical Exceptions examples
p p
Acceptance criterion failure
An interruption in the computer system or
the
th equipment’s performance
i t’ f
Other examples from the participants?
10. Basic Exception Process Flow
p
SME involvement throughout is
critical
You cannot document enough,
even if all of it does not make it
into the final event write-up
CAPA may not be needed for
simple events, but consider if
there are many of them or the
same ones repeatedly
11. General Process Considerations
Commence exception resolution process as soon
as event is observed
Involve SMEs/QA throughout process as
appropriate
Get agreement on next steps and/or results
g p
Prior to execution, or after the completion
Including all elements of the process
Immediately notify the relevant SME/QA if there is
any potential Product/Material impact
Conduct a risk assessment to determine impact
and actions
12. What is the risk and impact of
the exception?
Event severity x Testing Stage = Impact
Event Severity:
What kind of event is it? How was the event
caused?
Testing Stage:
Where are we in the validation/verification
process? Installation? Performance
Qualification?
13. Event Types
yp
Typographical errors
These errors are found prior to execution or are “obvious” errors or
typos
External Issues
Failures caused by factors external to the process or system under
test
Execution Errors
Failures to follow instructions within the Test Document or
referenced procedures.
Document Generation Errors
Incorrect detail in procedures, acceptance criteria or referenced
documentation
Acceptance Criteria Failures
Pre-defined acceptance criteria have not been achieved.
14. Testing Stage
g g
New system installation and the exception
does not impact the validation intent
New system i t ll ti and th exception
N t installation d the ti
does impact the validation intent
New or Existing system qualification
Process Validation
Re-qualification
15. Should testing stop?
g p
Depends on the impact score
Depends on consultation with SMEs and QA
Are you willing to live with a failure?
Will it open more q
p questions than it solves?
Note: It does not depend on the timeline!
16. Exception example #1
p p
An acceptance criterion was failed
failed.
However, the acceptance criterion was poorly set
(
(limited knowledge was available to set the acceptance
g p
criterion).
What level of exception is this?
What do you do?
17. Exception example #2
p p
The acceptance criterion was passed but the
passed,
result was right at the limit.
Assay variability is high for the test.
Is this an exception? Why or why not?
What do you do?
18. Exception example #3
p p
During validation of the cleaning process the
process,
Operator executing the protocol failed to sample
the correct locations.
Is this an exception? Why or why not?
What do you do?
20. The key to preventing
exceptions
ti
Understanding and reducing variation
variation.
Systems thinking (managing the flow through the
entire process as an entity)
entity).
21. Types of Variation (Including
Sampling,
Sampling Analytical and Production)
Variation in Quality Characteristic (specific activity
activity,
potency, pH, temperature…etc.
Process variation Variation in the way our
variation.
processes behave and are managed or controlled.
Variation in volume flowing through a process.
22. Why focus on variability?
y y
Reduced variation in Quality Characteristics
reduces rejects, rework and deviations. It
provides high First Pass Yields.
Reduced variation in Volume (smoother flow)
increases output capacity and reduces capital
requirements.
requirements
Reduced variation in Volume (smoother flow)
decreases cycle time and Work-In-Progress.
y g
23. Which one will be more likely to
fail an acceptance criterion?
Day shift Following night shift
2600
2400
2200
1-Point Average
2000
1800
1600
1400
1200
1000
50
70
90
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
11
13
15
17
19
21
23
25
27
29
31
33
35
37
39
41
43
45
47
49
26. What should you do?
y
CRITICAL ERRORS PER WORKER PER WEEK
WEEK
1 2 3 4 5 6 7 8 9 10 11 12 TOTAL
Mary 0 0 0 0 0 0 0 0 0 0 0 0 0
Joe 0 0 0 0 0 0 0 0 0 0 0 0 0
Eva 1 0 0 2 0 0 3 0 0 1 0 0 7
Fred 0 0 0 1 0 0 2 0 0 0 0 0 3
Jim 0 0 0 0 0 0 0 0 0 0 0 0 0
Ed 0 0 0 0 0 2 0 0 0 0 0 0 2
Kate 0 0 0 0 0 0 0 0 0 0 0 0 0
Carl 0 0 0 1 0 0 0 0 0 0 0 0 1
TOTAL 13
27. The lesson from Tribus
Bring a team together to focus on ensuring the aim
is clear to all participants
Focus on systems to reduce and remove possibility
for errors
Improve systems as a way to prevent human error.
Be very careful when assigning blame to human
error or to a specific p
p person
29. Three keys to exceptions
y p
Document
Document
Document!
30. Keep it simple!
p p
Document the standard questions:
Who
What
Wh t
When
Why
Where
How
31. Other requirements
q
Root Cause Determination
If root cause is unknown, a study should be
co duc ed
conducted
Impact Determination
How severe is the exception?
What is the impact to intent?
Corrective Action Determination
How will this be prevented in routine use?
Re Testing Re execution
Re-Testing / Re-execution
Is it necessary? Why or why not?
33. Exception example #4
p p
During the annual re qualification / re-verification of
re-qualification re verification
the performance of an autoclave which has been
used for manufacturing of p
g product, the
,
thermocouples did not achieve the required
temperature.
Is this an exception? Why or why not?
What do you do?
34. Exception example #5
p p
During the verification of the installation of Vessel
which has not been used to manufacture product,
p
power was lost during testing of the agitator.
g g g
Is this an exception? Why or why not?
What do you do?
35. Exception example #6
p p
During the re validation / re verification of Cleaning
re-validation re-verification
validation of a process which has NOT been used
to manufacture product, some samples were
p , p
accidentally not taken.
Is this an exception? Why or why not?
p y y
What do you do?
36. Exception example #7
p p
During the execution of an alarm check
(operational verification) for a system not used to
manufacture product, the test document had the
p ,
incorrect sequence of events.
Is this an exception? Why or why not?
p y y
What do you do?