Personal Hygiene for pharma industry-Dr. A. AmsavelDr. Amsavel A
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash – How and when
Training & Practice
by Dr. A. Amsavel
Personal Hygiene for pharma industry-Dr. A. AmsavelDr. Amsavel A
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash – How and when
Training & Practice
by Dr. A. Amsavel
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
Basic’s of Contamination
Sources of Contamination
Environment Specification
Elements of Cleanroom Design and Qualification
Definitions
Control of Contaminations
People, Cleaning, Environment & Material
Operation, Monitoring and Control
Documents and Records
Control on Cleanroom Environmental Monitoring (Pharmaceutical)Srinath Sasidharan
A general consideration of Environmental Monitoring in Pharmaceutical manufacturing area. Cleanroom Monitoring Tools and Utilities: Author Sreenath Sasidharan (Geltec Healthcare FZE)
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
Semiconductor Fab Trends and Forecast - June 2013SEMI
The presentation contains Information and data on frontend semiconductor and LED fabs
fabs. The charts and tables are from an article published on May 31, 2013. Visit http://www.semi.org/en/node/45921 to read the entire article.
Other resources:
www.semi.org/fabs
www.semi.org/marketinfo
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
Basic’s of Contamination
Sources of Contamination
Environment Specification
Elements of Cleanroom Design and Qualification
Definitions
Control of Contaminations
People, Cleaning, Environment & Material
Operation, Monitoring and Control
Documents and Records
Control on Cleanroom Environmental Monitoring (Pharmaceutical)Srinath Sasidharan
A general consideration of Environmental Monitoring in Pharmaceutical manufacturing area. Cleanroom Monitoring Tools and Utilities: Author Sreenath Sasidharan (Geltec Healthcare FZE)
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
Semiconductor Fab Trends and Forecast - June 2013SEMI
The presentation contains Information and data on frontend semiconductor and LED fabs
fabs. The charts and tables are from an article published on May 31, 2013. Visit http://www.semi.org/en/node/45921 to read the entire article.
Other resources:
www.semi.org/fabs
www.semi.org/marketinfo
Cleanrooms | Minimizing Risk to ProcessesCleanrooms
The overarching objective of a cleanroom is to minimize risk to the process. The risk comes from a variety of pollutants such as dust, airborne microbes, aerosol particles and chemical vapors.
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Understand the scope and compliance costs of the most recent CGMP standards and USP
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Dr. Jesse Martinez, PharmD, FASCP and Vice Dean of the College of Pharmacy,
Western University of Heath Sciences
Dr. Jesse Martinez has 37 years Of experience in compounding, sterile and non-sterile pharmacy operations and administration, and research. He has served on local, state and national pharmacy associations and currently teaches fourth-year pharmacy students in advanced Classes that include pharmacist-in-charge training. Jesse consults for the pharmacy industry and is a recognized expert in USP 795, 797 and 300 compliance.
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This is a small sample of the introductory section of a 12 hour short course entitled, "Getting Clean Parts and Getting Parts Clean". The complete course contains over 300 slides.
White paper - Key factors for developing a pharmaceutical cleaning strategyFedegari Group
Pharmaceutical Cleaning Strategies: What are the key factors to consider when developing a quality procedure?
Cleaning is an essential practice for any pharmaceutical activity: it is impossible to manufacture drugs in dirty conditions, even if dirt is not evident. Many aspects need to be considered in setting up a cleaning procedure. This is certainly a multidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality Control lab to Production department. Contributions of all these areas together can lead to a robust and reproducible cleaning process.
In these conditions, even regulatory bodies struggle. Essentially, they allow manufacturers considerable flexibility in establishing their own cleaning specifications. The FDA, for example, does not define methods describing how a cleaning process should be validated.
Therefore, there are many aspects to be considered when approaching the issue of pharmaceutical cleaning. First of all, one has to consider where to perform cleaning activity: in-place (CIP) or out-of-place (COP).
Cleaning is much important step in pharmaceutical production and delivering high quality products to the system .
Cleaning is done by multiple step approach and all that have necessary role in production of high quality accepted product.
To minimise the times , money and inventory we discovered the concept of CIP - i.e. Clean In Place
System.
By this system we clean and sterilize all the pharmaceutical equipment on working site , without any loss and dissemble that's the advantages of CIP .
And also other method of cleaning are explained here .
Bioburden Validation Strategy for Cleaning Validationangelsalaman
This presentation is based on the article published by Pharmaceutical Technology (USA) entitled “BIOBURDEN METHOD SUITABILITY FOR CLEANING AND SANITATION MONITORING: HOW FAR WE HAVE TO GO?”, Aug 2010. by Angel L. Salaman-Byron
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...PaulBryant58
This article provides a comprehensive guide on how to
effectively manage the convert Accpac to QuickBooks , with a particular focus on utilizing online accounting services to streamline the process.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
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Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
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The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Explore our most comprehensive guide on lookback analysis at SafePaaS, covering access governance and how it can transform modern ERP audits. Browse now!
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What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
14. Fundamentals of Contamination Control – the Basics A more complete glossary can be found in Chapter 1: Fundamentals of Contamination Control, in “ Contamination and ESD Control in High Technology Manufacturing” (Wiley, Hoboken, 2006) ISBN-13: 978-0-471-41452-0
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24. Reference Chapter 5: Getting Clean Parts and Getting Parts Clean in “ Contamination and ESD Control in High Technology Manufacturing”, (Wiley, Hoboken, 2006) ISBN-13: 978-0-471-41452-0
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28. Fundamentals of Contamination Control High Contam. Level Level In-coming Low Contam. Level 1 10 50 90 99 % Removal Sigmoidal (meaning S shaped) Cleaning Efficiency Curve How do they do get such high cleaning efficiencies? Where cleaning equipment vendors advertise. Does opportunity for improvement exist? Where most cleaning processes actually work. 20 to 80 % Removal Efficiency
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30. Fundamentals of Contamination Control High Contam. Level Level In-coming Low Contam. Level 1 10 50 90 99 % Removal Why it is important to know in-coming cleanliness level and percent removal efficiency is fairly low Where most cleaning processes actually work. 20 to 80 % Removal Efficiency Over a narrow range, cleaning efficiency curves appear to be linear
Editor's Notes
Roger is founder and principal scientist at R. W. Welker Associates. Prior to joining the disk drive industry in 1982, he spent 11 years in applied research and development, mostly as an aerosol scientist. While in the disk drive industry he became widely recognized as one of the foremost experts on contamination control, electrostatic discharge control and materials science. He has applied his expertise in these disciplines for over 26 years to semiconductors, disk drives, direct materials and consumable supplies, continuous monitoring, flat panel display, the precision chemicals industry and most recently, 6 years for the National Air and Space Administration. He returned to the disk drive industry in 2007 after 10 years of consulting. He has worked in many functions in high-technology industries, including manufacturing technology research, process development, product development, manufacturing engineering, quality assurance, supplier quality engineering and marketing. He originated many techniques that have emerged as industry standards, including analytical methods for specifying cleanroom gloves, swabs and wipers, and the widely circulated and practiced, “Guidelines for Design and Certification of Tooling for Cleanroom Use”. He is the author of more than 60 papers and presentations on contamination and ESD control. He is principal author of, “Contamination and ESD Control in High-Technology Manufacturing”, published by John Wiley and Sons, in Oct. 2006. Much of the material in this presentation appears in chapters 3, 5 and 8 in that book, though in highly abbreviated and not so colorful form.