The document discusses implementing risk management in the validation process. It emphasizes understanding risks and focusing validation efforts on high-risk areas. A three-stage approach to process validation is outlined: 1) process design, 2) implementation and qualification, and 3) continued process verification. Risk assessments should be used at all stages to prioritize activities and ensure the process remains controlled. The goal of stage 2 is to evaluate the design and determine if reproducible commercial manufacturing is possible. It must include facility, utility, and equipment qualification as well as a Process Performance Qualification.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Introduction to Risk assessment and management. What is risk assessment and management? How to evaluate risk and how to analyze risk? What is the necessity of risk assessment and management? What are the basic steps for risk assessment and management?
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Introduction to Risk assessment and management. What is risk assessment and management? How to evaluate risk and how to analyze risk? What is the necessity of risk assessment and management? What are the basic steps for risk assessment and management?
Using FMEA as a Risk Management Tool for Events SustainabilityPECB
When planning an event, we have to take into consideration issues such as environmental, social and economic. Actions need to be taken to address risks and opportunities. We need to establish the ways how to identify and evaluate them.
The webinar covers:
• Planning for Events Sustainability
• Risk Management Process for Sustainability
• Advantages of using the FMEA Risk Score
Presenter:
This webinar was hosted by PECB Certified Trainer and Founder/ CEO at Powerhouse Development and Coaching Academy, Ms. Mary Anne Concio.
Link of the recorded webinar published on YouTube: https://youtu.be/4IamxVdji9o
The chance (or probability) that a problem will occur and
The result (or impact) if that problem occurs is known as Risk.
Risk cannot be eliminated, only reduced.
Risks are meant to be taken.
This complete presentation has a set of thirty two slides to show your mastery of the subject. Use this ready-made PowerPoint presentation to present before your internal teams or the audience. All presentation designs in this Risk Analysis PowerPoint Presentation Slides have been crafted by our team of expert PowerPoint designers using the best of PPT templates, images, data-driven graphs and vector icons. The content has been well-researched by our team of business researchers. The biggest advantage of downloading this deck is that it is fully editable in PowerPoint. You can change the colors, font and text without any hassle to suit your business needs.
Risk Assessment And Mitigation Plan PowerPoint Presentation SlidesSlideTeam
This deck consists of total of thirty three slides. It has PPT slides highlighting important topics of Risk Assessment And Mitigation Plan Powerpoint Presentation Slides. This deck comprises of amazing visuals with thoroughly researched content. Each template is well crafted and designed by our PowerPoint experts. Our designers have included all the necessary PowerPoint layouts in this deck. From icons to graphs, this PPT deck has it all. The best part is that these templates are easily customizable. Just click the DOWNLOAD button shown below. Edit the colour, text, font size, add or delete the content as per the requirement. Download this deck now and engage your audience with this ready made presentation.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
The Known Unknown - Importance of Project Risk Management by Mr Wissam YaacoubPMILebanonChapter
Mr. Wissam Yaccoub delivered a talk to PMI Lebanon Chapter about The Known Unknown - Importance of Project Risk Management in March 2019.
Among the Talking Points & Agenda:
Risk tolerance and uncertainty
Risk assessment game
Risk culture in life and organizations
Project risk management processes
How to plan, identify, and analyze risk
Uplifted risk register template
Group risk exercise
Identify risks and hazards that have the potential to harm any process or project. Use content-ready Risk Assessment PowerPoint Presentation Slides to analyse what can go wrong, how likely it is to happen, what potential consequences are, and how tolerable the identified is. With the help of ready-made risk assessment PowerPoint presentation slideshow, use control measures to eliminate or reduce any potential risk related situation. This deck comprises of various templates to control risks such as types of risks, risk categories, identify the risk categories, stakeholder engagement, stakeholders risk appetite, risk tolerance, procedure, risk management plan, risk register, risk identification, risk assessment, risk analysis, risk response plan, risk response matrix, risk control matrix, risk item tracking, risk impact and probability analysis, risk mitigation strategies, qualitative risk analysis, quantitative risk analysis, risk management process, risk management steps, and more. These templates are completely customizable. You can easily edit the color, text, icon and font size as per your need. Add or remove content, if needed. Grab this easy-to-understand risk assessment PowerPoint templates to figure out what could cause harm to the project, whether the hazards could be eliminated or not, what preventive measures should be taken to control the risks. Download risk assessment PPT slides now to execute the project easily. Behave in a down to earth fashion with our Risk Assessment Powerpoint Presentation Slides. Give them a glimpse of your fact based approach.
Risk Management Process Steps PowerPoint Presentation Slides SlideTeam
It covers all the important concepts and has relevant templates which cater to your business needs. This complete deck has PPT slides on Risk Management Process Steps PowerPoint Presentation Slides with well suited graphics and subject driven content. This deck consists of total of fifty four slides. All templates are completely editable for your convenience. You can change the colour, text and font size of these slides. You can add or delete the content as per your requirement. Get access to this professionally designed complete deck presentation by clicking the download button below.
Using FMEA as a Risk Management Tool for Events SustainabilityPECB
When planning an event, we have to take into consideration issues such as environmental, social and economic. Actions need to be taken to address risks and opportunities. We need to establish the ways how to identify and evaluate them.
The webinar covers:
• Planning for Events Sustainability
• Risk Management Process for Sustainability
• Advantages of using the FMEA Risk Score
Presenter:
This webinar was hosted by PECB Certified Trainer and Founder/ CEO at Powerhouse Development and Coaching Academy, Ms. Mary Anne Concio.
Link of the recorded webinar published on YouTube: https://youtu.be/4IamxVdji9o
The chance (or probability) that a problem will occur and
The result (or impact) if that problem occurs is known as Risk.
Risk cannot be eliminated, only reduced.
Risks are meant to be taken.
This complete presentation has a set of thirty two slides to show your mastery of the subject. Use this ready-made PowerPoint presentation to present before your internal teams or the audience. All presentation designs in this Risk Analysis PowerPoint Presentation Slides have been crafted by our team of expert PowerPoint designers using the best of PPT templates, images, data-driven graphs and vector icons. The content has been well-researched by our team of business researchers. The biggest advantage of downloading this deck is that it is fully editable in PowerPoint. You can change the colors, font and text without any hassle to suit your business needs.
Risk Assessment And Mitigation Plan PowerPoint Presentation SlidesSlideTeam
This deck consists of total of thirty three slides. It has PPT slides highlighting important topics of Risk Assessment And Mitigation Plan Powerpoint Presentation Slides. This deck comprises of amazing visuals with thoroughly researched content. Each template is well crafted and designed by our PowerPoint experts. Our designers have included all the necessary PowerPoint layouts in this deck. From icons to graphs, this PPT deck has it all. The best part is that these templates are easily customizable. Just click the DOWNLOAD button shown below. Edit the colour, text, font size, add or delete the content as per the requirement. Download this deck now and engage your audience with this ready made presentation.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
The Known Unknown - Importance of Project Risk Management by Mr Wissam YaacoubPMILebanonChapter
Mr. Wissam Yaccoub delivered a talk to PMI Lebanon Chapter about The Known Unknown - Importance of Project Risk Management in March 2019.
Among the Talking Points & Agenda:
Risk tolerance and uncertainty
Risk assessment game
Risk culture in life and organizations
Project risk management processes
How to plan, identify, and analyze risk
Uplifted risk register template
Group risk exercise
Identify risks and hazards that have the potential to harm any process or project. Use content-ready Risk Assessment PowerPoint Presentation Slides to analyse what can go wrong, how likely it is to happen, what potential consequences are, and how tolerable the identified is. With the help of ready-made risk assessment PowerPoint presentation slideshow, use control measures to eliminate or reduce any potential risk related situation. This deck comprises of various templates to control risks such as types of risks, risk categories, identify the risk categories, stakeholder engagement, stakeholders risk appetite, risk tolerance, procedure, risk management plan, risk register, risk identification, risk assessment, risk analysis, risk response plan, risk response matrix, risk control matrix, risk item tracking, risk impact and probability analysis, risk mitigation strategies, qualitative risk analysis, quantitative risk analysis, risk management process, risk management steps, and more. These templates are completely customizable. You can easily edit the color, text, icon and font size as per your need. Add or remove content, if needed. Grab this easy-to-understand risk assessment PowerPoint templates to figure out what could cause harm to the project, whether the hazards could be eliminated or not, what preventive measures should be taken to control the risks. Download risk assessment PPT slides now to execute the project easily. Behave in a down to earth fashion with our Risk Assessment Powerpoint Presentation Slides. Give them a glimpse of your fact based approach.
Risk Management Process Steps PowerPoint Presentation Slides SlideTeam
It covers all the important concepts and has relevant templates which cater to your business needs. This complete deck has PPT slides on Risk Management Process Steps PowerPoint Presentation Slides with well suited graphics and subject driven content. This deck consists of total of fifty four slides. All templates are completely editable for your convenience. You can change the colour, text and font size of these slides. You can add or delete the content as per your requirement. Get access to this professionally designed complete deck presentation by clicking the download button below.
Talent strategy for retaining super talent in the organisation is explained with the help of examples. This can be found in an article in People Matters dated August
Various steps of risk assessment. md. anwar ibrahim mirazMDAnwarIbrahimMiraz
The aim of the risk assessment process is to evaluate hazards, then remove that hazard or minimize the level of its risk by adding control measures, as necessary. By doing so, you have created a safer and healthier workplace.
This presentation was made by Mónica Caballero Jarilla, Major Financial Controller, Head of the Area of Economic Affairs, Directorate of Guardia Civil, Spanish Ministry of Defense. The webinar organised by SIGMA was held on 10 March 2021. Its main objective was to discuss how senior public managers manage the risks associated to public financial management, especially during the COVID-19 pandemic crisis.
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
This presentation f=gives Overview of Quality Risk Management Process and presents case studies for application of QRM in Manufacturing Operations.
◦ Drug Substance Attributes
◦ Excipient Selection
◦ Process Selection
◦ Formulation Development & Optimisation
◦ “Manufacturing Process Development
This presentation presents how Quality Risk management can be applied in Commissioning & Qualification of Facility , System and Equipments in Pharmaceutical Facilities.
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 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 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 reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
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.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
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