As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
Benchmarking is the continuous process of comparing one’s business processes and performance metrics to industry bests and/or best practices from other industries. Dimensions typically measured are quality, time, and cost.
Improvements from learning mean doing things better, faster, and cheaper.
Benchmarking is the process of improving performance by continuously identifying, understanding, and adapting outstanding practices found inside and outside the organization.
No organisation is the best at everything it does. And being second in most activities can add up to coming first overall. All managers recognise that it is up to them to improve continuously the operations that they are responsible for. But that aspiration is blunted because they don’t know how much better their performance could be.
Benchmarking is the structured comparison of an organisation’s products, services, processes or activities with those of an external organisation that is believed to have better performance. The goal is to pinpoint the factors that contribute to that superiority, and to adopt them.
Organisations usually compare themselves with the leaders in their own industrial sectors. But comparison can also be made with processes that, although in other sectors, have similar characteristics – such as shared service centres. An airline compared the processes in the ‘turnaround time’ for planes with those used in pit stops for racing cars. Benchmarking with non-competitors
can increase the quality and quantity of the information available.
Benchmarking is the process of measuring products, services, and processes against those of organizations known to be leaders in one or more aspects of their operations.
It is a way of discovering what is the best performance being achieved – whether in a particular company, by a competitor or by an entirely different industry. This information can then be used to identify gaps in an organization’s processes in order to achieve a competitive advantage.
Benchmarking can help you identify areas, systems, or processes for improvements—either incremental improvements or dramatic improvements.
CHAPTER-1 Management Audit and Planning procedure.pdfDr. Dinesh Mehta
Audits are conducted to ascertain the validity and reliability of the information; also to provide an assessment of the internal control of a system. It provides management with information on the efficiency with which the company controls the quality of its processes and products
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
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.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Chapter 3 - Islamic Banking Products and Services.pptx
Regulatory compliance and Benchmarking.pptx
1. Regulatory compliance And
Benchmarking
PRESENTED BY
M NATARAJ,
2261050004,
M.PHARM – PQA – 1ST YEAR,
DEPARTMENT OF
PHARMACY,
ANNAMALAI UNIVERSITY .
SUBMITTED TO
DR.K.DEVI,MPHARM.,PH.D,
ASSISTANT PROFESSOR,
DEPARTMENT OF PHARMACY
ANNAMALAI UNIVERSITY
5. Introduction
Regulatory compliance means being in accordance with the
regulations set out by regulators.
It is being in a state where the regulatory requirements are
met to the fullest extent, as required by regulatory agencies.
Meeting regulatory requirements is a prime requirement for
everyone who is part of an industry that is regulated.
6. These regulations are made by the regulatory agencies across
the world,
ensure the quality of products that are made by organizations in
their industry.
Meeting regulatory compliance requirements is important for
business in al sectors, but is of critical importance to
pharmaceutical and medical devices.
7. What is complaiance ?
The basic meaning focuses on target populations of
regulation.
Compliance Fulfillment/
conformity
9. Compliance program
To review policies and procedures through which
industry complies with the various regulations
Program to prevent and detect violations of the
regulations
10. Strategies to achieve compliance
• Creating an environment that supports compliance
• Making compliance part of everyone's job
• Empowering the quality assurance sytem
• Employ the appropriate skill to optain cooperation
• Educating other departments
• Selling the benefit of quality and compliance
• Using internal audit effectively
• Reviewing and reporting quality and compliance data
• Explaining the consequence of noncompliance
11. WHY IS COMPLAIANCE IMPORTANTANCE
Risk elimination
• Regulatory agencies act in public interest
• lay out guidelines for products and services
• Following these guidelines help avoid:
• Fines and penalties
• Litigation
• Business interruptions
• Market delays
• Contract breaches
12. Enhance customer and investor
confidence
No product is likely to gain the trust from everyone who matters,
right from the customers, stakeholders, employees and
investors alike, unless it has met regulatory compliance
requirements.
Complying with regulatory requirements is the highest and
surest guarantee and safeguard for the efficiency and efficacy
of a product.
13. Regulation of compliances
It is well known fact in India that FDA ensures the quality
of drug products by carefully monitoring drug
manufacturers’ compliance with its cGMP regulations.
Quality assurance (QA) is a department put in place to
make sure they can meet this requirements.
But, now a day’s US FDA realized that companies are
focusing only on compliance and not sufficiently
concentrating on quality.
14. Regulatory compliance and quality are not the same,
Compliance is simply putting out sufficient effort to meet
cGMP’s minimum requirements.
Quality is systematic continuous improvement process that
deliver intended performance.
Quality is not only compliance, but even more such as
improved productivity, increased profitability and building brand
etc.
15. Ten years ago the US FDA created “A Vision for 21st
Century Manufacturing”.
With a goal for developing an efficient, flexible pharma
manufacturing sector producing high-quality drugs without
extensive regulatory oversight.
It resulted in improvement of facilities, modernizing control
platforms/process technologies, quality-by-design (QbD)
programs
18. Introduction
Benchmarking was originally defined by D.T.
Kearns, the CEO of Xerox Corporation, in 1981 as
the continuous process of measuring products,
services, and practices against the toughest
competitors.
19. What is benchmarking
Benchmarking is the process of improving performance
by continuously identifying, understanding, and adapting
outstanding practices found inside and outside the
organization.
Benchmarking is Making Best Practices Your Daily
Practice. Benchmarking is the process of comparing
one’s business processes and performance metrics to
industry bests and/or best practices from other industries.
20. Why are others better?
How are others better?
What can we learn?
How can we catch up?
How can we become the best in our sector?
21. Features of benchmarking
Continuous method of measuring and
comparing a firms business processes
against those of another firm
Discover performance gaps between ones
own processes and those of leading firms
Incorporate leading firms processes into
ones own strategy to fill the gaps and
improve performance
22. Improvement status
Benchmarking is a tool for continuous improvement of the
management of processes in companies to help them to
gain world leadership.
23. Why benchmarking
Traditional performance improvement trends seem not to be
sufficient for the highly competitive markets.In other words
external environment and market conditions change rapidly
Customers’ expectations are highly liquid and are driven by
standards set by best performer.Any product or service just
below these standards may not catch the eyes of customer.
28. What is being with
compared other
organisations
ON THE BASIS OF “WHAT”
IS BEING COMPARED
WITH OTHER
ORGANIZATIONS AND
“WHO” IS BEING
COMPARED WITH OUR
ORGANIZATION, WE CAN
CLASSIFY
BENCHMARKING.
What is being compared with
other organizations
Who is being compared with
our organization
29.
30. Internal benchmarking
This refers to the analysis and comparison of one or more
units within the same organization.
31. External benchmarking
Where examples of good practices can be found in other
organizations and there is a lack of good practices within
internal business units.
32. Strategic benchmarking
Strategic benchmarking deals with top management. It deals
with long term results. Strategic benchmarking focuses on how
companies compete.
This form of benchmarking looks at what strategies the
organizations are using to make them successful.
This is concerned with comparing different companies’
strategies and assessing the success of those strategies in the
marketplace.
33.
34. Performance benchmarking
Performance benchmarking focuses on assessing
competitive positions through comparing the products and
services of other competitors.
When dealing with performance benchmarking,
organizations want to look at where their product or services
are in relation to competitors on the basis of things such as
reliability, quality, speed, and other product or service
characteristics.
35. Process benchmarking
Process benchmarking focuses on the day-to-day
operations of the organization. It is the task of
improving the way processes performed every day.
Some examples of work processes that could utilize
process benchmarking are the customer complaint
process, the billing process, the order fulfillment
process, and the recruitment process.
36.
37. Advantages of benchmarking
Learn from others experience & practices.
It allows examination of present processes
Aids change & improvement.
Exposes performance gaps
38.
39. Disadvantages of benchmarking
Poorly defined benchmarks may lead to waste effort
and meaningless results.
Some organizations have reluctance to share the
information.
Benchmarking cannot change all required
improvement at once.
40.
41. Limitations of benchmarking
Benchmarking is a tough process that needs a lot of
commitment to succeed.
Benchmarking should be a continues process as the
competition is always changing.
Selection and empowerment of benchmarking teams.
The adaptability of the practices should be tested and
the implementation results should be verified.
42. References
Implementing Juran’s Road Map For Quality Leadership:
Benchmarks And Results, By Al Endres, Wiley, 2000 Pg No-
12.1
Camp, Robert C. (1994). Business Process Benchmarking:
Finding And Implementing Best Practices, ASQC Quality
Press, Milwaukee.
M. R. & Amin, N. A. (2003). Benchmarking Learning
Outcomes Of Undergraduate Business Education
Benchmarking: An International Journal, 10(6), 538-558.
43. Anderson, B. (1999), “Industrial benchmarking for
competitive advantage”, Human Systems Management,
Vol. 18 No. 3.
Bogan, C.E. and M.J English (1994), Benchmarking for
Best Practices: Winning Through Innovative Adoption, New
York: McGraw-Hill.
Boxwell, Robert (1994), Benchmarking for a Competitive
Advantage, McGraw Hill, 1994
