Tonkin’s Cleaning Validation workshop provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The workshop program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a “Cleaning Validation Master Plan” and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.
Cleaning validation case studies from pharmaceutical, biologic and biopharmaceutical manufacturing processes will be included.
Learning Objectives:
At the end of this 2 day workshop, you will have a better understanding of:
• To provide an overview and clear understanding on Cleaning Process and Cleaning Validation w.r.t Biopharmaceutical and Pharmaceutical Industry.
• Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
• What to Clean and why to clean
• How to develop a Cleaning Cycle
• How to execute a Cleaning process
• How to Sample and fix a limit for Cleaning process
• How Cleaning Validation protocol to be written
• How to main the Cleaning process in Validated process
• Finally importance of Cleaning process w.r.t contamination and Regulatory Inspection
• How to identify the Residues and fix the Limits
• Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
• What are residues to be considered for Cleaning process
• How to fix the limits for effective cleaning process
• What is the acceptable Level or Limit for ensuring that cleaning process is satisfactory? Visually clean, LTD, MDD, 10ppm, MACO, NOEL and other criteria
• Best Practices for risk assessment and justification of cleaning targets and residue limits
• Different Sampling Techniques for Cleaning Validation
• Microbial Issues to be considered in cleaning Validation
• Cleaning Validation protocols development and Cleaning Validation strategies
• How to maintain the Cleaning process under Validated status
Course Director:
Umesh Baikunje
Sr. General Manager - Quality and Regulatory Affairs
Stempeutics
Tonkin’s Cleaning Validation workshop provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The workshop program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a “Cleaning Validation Master Plan” and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.
Cleaning validation case studies from pharmaceutical, biologic and biopharmaceutical manufacturing processes will be included.
Learning Objectives:
At the end of this 2 day workshop, you will have a better understanding of:
• To provide an overview and clear understanding on Cleaning Process and Cleaning Validation w.r.t Biopharmaceutical and Pharmaceutical Industry.
• Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
• What to Clean and why to clean
• How to develop a Cleaning Cycle
• How to execute a Cleaning process
• How to Sample and fix a limit for Cleaning process
• How Cleaning Validation protocol to be written
• How to main the Cleaning process in Validated process
• Finally importance of Cleaning process w.r.t contamination and Regulatory Inspection
• How to identify the Residues and fix the Limits
• Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
• What are residues to be considered for Cleaning process
• How to fix the limits for effective cleaning process
• What is the acceptable Level or Limit for ensuring that cleaning process is satisfactory? Visually clean, LTD, MDD, 10ppm, MACO, NOEL and other criteria
• Best Practices for risk assessment and justification of cleaning targets and residue limits
• Different Sampling Techniques for Cleaning Validation
• Microbial Issues to be considered in cleaning Validation
• Cleaning Validation protocols development and Cleaning Validation strategies
• How to maintain the Cleaning process under Validated status
Course Director:
Umesh Baikunje
Sr. General Manager - Quality and Regulatory Affairs
Stempeutics
Indiana Governor Eric Holcomb and state Republican lawmakers have reached an agreement when it comes to the state’s budget. The deal has more money for schools and rural broadband, and also pays off $1 billion in debt.
More money for education and no increase in the cigarette tax are two of the key highlights in the budget unveiled today by Indiana Senate Republicans.
A poll commissioned by Democratic State Senator Karen Tallian shows she is tied with incumbent Republican Curtis Hill.
The poll of more than 890 likely voters showed both Hill and Tallian were tied at 36 percent each and 28% were undecided.
Three independent gas station owners, an environmental engineering firm, and the United States Small Business Owners Association (USSBOA), which represents approximately 900 independent gasoline and convenience stores in Indiana, filed a class-action lawsuit this afternoon against the Indiana Department of Environmental Management (IDEM) and Deputy Assistant Commissioner Douglas R. Louks.
Indiana Governor Eric Holcomb vetoed legislation that would have severely restricted a local government's ability to regulate landlord-tenant relationships/.
Executive order 20 09 (continuity of government operations)Abdul-Hakim Shabazz
Here are the latest executive orders issued today by Governor Eric Holcomb in regards to the coronavirus. This one involves State government operations.
Executive order 20 10 (enforcement of in-person dining prohibition)Abdul-Hakim Shabazz
Here are the latest executive orders issued today by Governor Eric Holcomb in regards to the coronavirus. This one involves the prohibition on in person dining.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Indiana Governor Eric Holcomb and state Republican lawmakers have reached an agreement when it comes to the state’s budget. The deal has more money for schools and rural broadband, and also pays off $1 billion in debt.
More money for education and no increase in the cigarette tax are two of the key highlights in the budget unveiled today by Indiana Senate Republicans.
A poll commissioned by Democratic State Senator Karen Tallian shows she is tied with incumbent Republican Curtis Hill.
The poll of more than 890 likely voters showed both Hill and Tallian were tied at 36 percent each and 28% were undecided.
Three independent gas station owners, an environmental engineering firm, and the United States Small Business Owners Association (USSBOA), which represents approximately 900 independent gasoline and convenience stores in Indiana, filed a class-action lawsuit this afternoon against the Indiana Department of Environmental Management (IDEM) and Deputy Assistant Commissioner Douglas R. Louks.
Indiana Governor Eric Holcomb vetoed legislation that would have severely restricted a local government's ability to regulate landlord-tenant relationships/.
Executive order 20 09 (continuity of government operations)Abdul-Hakim Shabazz
Here are the latest executive orders issued today by Governor Eric Holcomb in regards to the coronavirus. This one involves State government operations.
Executive order 20 10 (enforcement of in-person dining prohibition)Abdul-Hakim Shabazz
Here are the latest executive orders issued today by Governor Eric Holcomb in regards to the coronavirus. This one involves the prohibition on in person dining.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
