EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...Merck Life Sciences
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Definition and Objectives of Lyophilization, Advantages & Disadvantages, Basic Principles of Lyophilization, Steps of Lyophilization,
Main Components of Lyophilizer,
Qualification of Lyophilizer,
Development of Lyophilization cycle, Defects of Lyophilizer.
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...Merck Life Sciences
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...Merck Life Sciences
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Definition and Objectives of Lyophilization, Advantages & Disadvantages, Basic Principles of Lyophilization, Steps of Lyophilization,
Main Components of Lyophilizer,
Qualification of Lyophilizer,
Development of Lyophilization cycle, Defects of Lyophilizer.
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...Merck Life Sciences
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.
This presentation contains
Introduction, Advantages & Disadvantages, Process of manufacturing, Evaluation and defects in Blister, strip & ALU ALU Packaging. Useful for pharmacy students to understand the concept of blister & strip packaging
Good Manufacturing PracticeFor LVP,SVP, ophthalmic veterinary medicine, bulk chemicals & invitro diagnostic
For Good business Practice
A control process gives reproducibility & product consistency with in known limits
Provides license to do business.
Pharmaceutical Isolator technology in aseptic processingPalash Das
These articles describe different aspects of aseptic processing Isolator.
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half- suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling. The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel.
Key to Successful Formulation Development for Lipid Based RNA Delivery and Va...MilliporeSigma
In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
ICH stability guidances provide guidance for new drug substances and drug products .CDER now wishes to apply these recommendations to ANDAs. Specific recommendations were given in FDA “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products. Recently FDA issued “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers.
Drug Regulations has prepared a presentation on ANDA stability requirements.
Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.
This presentation contains
Introduction, Advantages & Disadvantages, Process of manufacturing, Evaluation and defects in Blister, strip & ALU ALU Packaging. Useful for pharmacy students to understand the concept of blister & strip packaging
Good Manufacturing PracticeFor LVP,SVP, ophthalmic veterinary medicine, bulk chemicals & invitro diagnostic
For Good business Practice
A control process gives reproducibility & product consistency with in known limits
Provides license to do business.
Pharmaceutical Isolator technology in aseptic processingPalash Das
These articles describe different aspects of aseptic processing Isolator.
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half- suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling. The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel.
Key to Successful Formulation Development for Lipid Based RNA Delivery and Va...MilliporeSigma
In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
ICH stability guidances provide guidance for new drug substances and drug products .CDER now wishes to apply these recommendations to ANDAs. Specific recommendations were given in FDA “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products. Recently FDA issued “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers.
Drug Regulations has prepared a presentation on ANDA stability requirements.
We manufacture and exports all kinds of rubber products. Our products range is known for excellent strength, high end features, resistance to chemicals, durability, non toxicity and high elasticity.
Lotus Surgicals manufacture medical devices that are a cut above the rest. We offer complete range of Absorbable and Non-absorbable, Braided and Monofilament Sutures catering to every speciality, including cardiovascular and plastic surgery. We also offer other medical device comprising different varieties of surgical mesh, clips and appliers, surgical staplers , surgical kits etc.
Appreciated by customers across the nation for supplying, trading and wholesaling a broad array of high quality pharmaceutical hygiene & cleanRoom
products, June Enterprises started its operations in December 2013.
In a short span of time, the company expanded its breadth of operations to provide CleanRoom Products to the Indian pharmaceutical industry &
neighboring countries.
The product range offered by June Enterprises includes: – Sterilization Monitoring & Validation Products, ATCC Culture, Cleanroom Garments &
Accessories, Cleanroom Supplies, Critical Cleaning Products, Products for Food & Facilities, Sterilization Packaging & Sealing Products, Products for
Stores & Warehouses, USP Class Silicone Tubing among others.
In order to ensure high standards of quality, the offered range of Cleanroom Products is procured and sourced from trusted and reliable Leaders in their
® ® respective product ranges for example Sterilization Products by Mesa Labs, Cleaning & disinfectants by Contec & ATCC by Microbiologics.
With years of experience, expertise and a proven track-record of helping many companies with its CleanRoom Products & Sterilization needs, June
Enterprises has established an enviable position in the PHARMA, FOOD & HOSPITAL segments.
JUNE Enterprises is an ISO 9001:2015 certified company.
Learn More: https://www.juneenterprises.com/
Labindia instruments Pvt. Ltd. Is primarily engaged in providing comprehensive solutions in Life and Analytical Sciences. We market and support analytical, biotechnology and laboratory instruments and solutions that includes natural gas generators, hanson dissolution tester, lab TOC analyzer, automatic laboratory titrators, dissolution test apparatus, melting range apparatus, titrators, automatic titrators, ph meters, conductivity meters, spectrophotometer, tablet testers, gas chromatograph, toc analyzer, Dissolution Test Apparatus, Disso DS 8000 Dissolution Test Apparatus, Karl Fischer Titrators (KAFI), Hanson Dissolution Tester, Hanson Media-Mate PlusTM, Coulometric Karl Fischer Titrators etc.
Hahnemühle‘s Albet LabScience brand is a range of products designed for general filtration applications and complex filtration processes in life science and analytical applications in chemical and biological laboratories. The technical specifications of our membranes and syringe filters allow their use in areas where reproducibility and consistency are of major importance.
Quality
Our syringe filters undergo strict quality controls during and after production. The storage life of the finished products in the
warehouse is constantly monitored. Each filter holder undergoes the following five tests: bubble point, burst pressure, membrane absorption, flow rate and extractable substances. The range includes filter holders for the reliable separation of microorganisms and particles in liquids, air and other gases. Clear and sterile filtration, sample production, sterile aeration and medical applications are just some of the areas where disposable filter holders are typically used. They are available in different pore sizes and with different hydrophilic or hydrophobic membrane materials.
Our microfiltration range also includes membrane units. The first step towards successful analysis is choosing the right membrane unit. We offer you different membrane filters with pore sizes from 0.2 μm – 8 μm for particle removal or for the collection of the microorganisms to be examined from solutions. Various cellulose-based membranes and polymer materials cover a wide range of application areas, from clarification and sample preparation to sterile and air filtration to aeration and microbiological control. See our quick and easy to use guidelines on page 8f, which will help you to decide which product is perfect for you.
Chem Zone is committed to remain at the forefront for the supply of laboratory need for Industrial, Educational & Government Institute’s, Analytical & Environmental labs, Technical Education in Pakistan.
At Aseptic Technologies we developed and manufacture innovative solutions for aseptic filling operations. Our equipment and devices are designed to provide safer & easier sterility assurance for aseptic fill and finish of biologicals, potent drugs and products requiring cryopreservation.
Kemwell biologics presentation bp April 2018MithaliRosario
Founded in 1980, Kemwell provides customized process/product development and manufacturing to biopharmaceutical organizations worldwide. Our facilities are located in Bangalore, India and were built with technical guidance from Boehringer Ingelheim, providing customers with state-of-the-art technology along with the benefit of cost-effective manufacturing.
The 15,000 sq. m. facility consist of a cGMP drug substance manufacturing facility with 2x2000L bioreactors and a sterile fill and finish facility for cGMP drug product manufacturing with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation.
For over 30 years, Kemwell supported pharmaceutical companies with their development and manufacturing needs. We developed and manufactured drugs for some of the world’s top pharmaceutical companies including Bayer, GlaxoSmithKline, Merck KGaA, Novartis and Pfizer. In 2017, Kemwell sold its pharmaceutical business to Recipharm AB but continues to leverage its 30-year experience to provide biotech customers with cost-effective solutions.
Whitenair Technologies offers impeccable array of Clean Air/Controlled Environment Solutions to a diverse range of industries that help keep product, people and process free from contamination. Our offered products are highly appreciated by our wide spread clients. We offer a range that comprises of Modular Clean Rooms, Air Handling Units , Bio-safety Cabinets, Laminar Air Flow Units , Dispensing/Sampling Booths, Cytotoxic safety cabinets , PCR Cabinets, Animal Handling work stations, Weighing cabinets, IVF Cabinets, Glove boxes, Sterile Garment Cabinets, Air Showers, Pass Box, Fan filter unit, Pressurizing Modules, Mobile Trolley, Wet processing and Cleaning Cabinets and Fume Cupboards . Clean room & laboratory furniture etc .
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
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.
www.seribangash.com
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
Attending a job Interview for B1 and B2 Englsih learnersErika906060
It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
Skye Residences | Extended Stay Residences Near Toronto Airportmarketingjdass
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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
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
Website – www.pmday.org
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"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
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.
Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
5. PHARMACEUTICAL PACKAGING
SCHOTT KAISHA brings technological products from
SCHOTT forma vitrum product range (1)
0.5 ml to 50 ml
Break Systems:
- OPC (one-point cut)
- color-break ring
Colour rings on the
stem or body
Printed ampoules
(heavy metal free
colours)
2 ml to 100 ml
Resistance to
breakage
Transparency
comparable to glass
Excellent barrier
properties
High chemical
resistance
Broad variety from
1 ml to 100 ml
With or without
blowback
Special designs for
lyophilization
Dual-chamber
(“mixer”) vials
Screw neck vials
Vials
made of glass
Cartridges
made of glass
SCHOTT TopPac®
Vials
made of COC polymer
Ampoules
made of glass
For pen systems
For pump systems
Dual-chambered
cartridges
Auto-injectors
Needle free
injectors
Dental cartridges
Broad range of ampoules, vials and cartridges
6. PHARMACEUTICAL PACKAGING
Coated vials for sensitive drugs and vials for special applications
Containers with a quartz-
like inner surface for im-
proved chemical stability and
inertness
Particularly suited for bio-
pharmaceutical products
with
adsorption tendencies, high
pH values, susceptibility to a
shift in pH value, sensitivity
to traces of metal ions,
complexing agents like
Inner glass container of
pharmaceutical type I glass
for best compatibility
Specially shaped glass
design for highest pressure
resistance
Outer polymer shell for
protection and mechanical
strength
Choose your own design
and color
Optimized gemetry of the vial
Hydrophobig coating
Advantages:
Elegant lyophilisation cake
Less disruption of dry material
Less adhesion to glass surface
Improved drug removal after
reconstitution
Reduced glass breakage
Improved heat transfer
SCHOTT TopLyo™ SCHOTT PURGARD®
SCHOTT Type I plus®
SCHOTT KAISHA brings technological products from
SCHOTT forma vitrum product range (2)
7. PHARMACEUTICAL PACKAGING
Dropper pipettes and plastic closure systems
Pre-washed and siliconized
Integrated printing to avoid
contamination
Assembled with caps and
droppers
Special packaging ready for
sterilization
screw neck vials + screw caps,
tablet bottles + snap caps
Standards: GL 14, GL 18 and GL 22
Special shapes on customer request
Plastic closure systems
and custom moulding
Dropper Pipettes
SCHOTT KAISHA brings technological products from
SCHOTT forma vitrum product range (3)
8. PHARMACEUTICAL PACKAGING
Slide 8
SCHOTT forma vitrum - setting performance standards
in parenteral packaging
MATERIALS MATERIA
IALS MATERIALS MAT
TERIALS MATERIALS
PRODUCTS PRODUCT
TS PRODUCTS PRODU
PRODUCTS PRODUCT
TECHNOLOGY TECHN
NTECHNOLOGY TECH
LOGY TECHNOOLOGY
A unique selection of material technologies, product designs and
quality options to your choice
StandardLineStandardLine
ClearLineClearLine
TopLineTopLine
Continuous research and development
assures that our portfolio meets the
demands of today’s and tomorrow’s
market place, from standard up to
sophisticated customer requirements.
GLASSGLASS
POLYMERPOLYMER
COATING TECHNOLOGYCOATING TECHNOLOGY
Our expertise on material technology and
excellent raw materials are the basis for
innovative product solutions.
VIALSVIALS
SYRINGESSYRINGES
AMPOULESAMPOULES
CARTRIDGESCARTRIDGES
SCHOTT forma vitrum offers a complete
product range: a “one-stop-shop” for our
customers.
23. PHARMACEUTICAL PACKAGING
Slide 23
Home Tech
The SCHOTT Group
Pharmaceutical
Systems
Electronic
Packaging
Solar
Advanced
Materials
Flat Glass Fiber Optics
24. PHARMACEUTICAL PACKAGING
Slide 24
syringes, cartridges, vials, ampoules
made of special glass
special glass tubing pharmaceutical excellence
…and high tech polymer
Business Unit Pharmaceutical Systems:
Tubing & Pharmaceutical Packaging
25. PHARMACEUTICAL PACKAGING
Slide 25
Key figures (FY 2008)
SCHOTT Group
2.23 billion € sales worldwide
289 million € capital expenditures
Production plants and sales offices in 41 countries
17,300 employees (as of January 2009)
Business Segment Pharmaceutical Packaging
260 million € sales worldwide
40 million € capital expenditures
3,100 employees
SCHOTT
pharmaceutical Packaging
operates
under the brand name
SCHOTT forma vitrum
26. PHARMACEUTICAL PACKAGING
Slide 26
Our Vision
“We set performance standards
in parenteral packaging.”
Our Mission
Future-oriented and committed to be the leading supplier of innovative parenteral packaging
as well as a creative solution provider for drug delivery systems worldwide.
As innovators we are setting standards with respect to quality, technology, and service.
Our units operate in a GMP environment. Reliability and security of supply worldwide are
our strengths.
Dedicated customer orientation, entrepreneurial initiative, and continuous improvement at
all levels make us a reliable partner for the pharmaceutical industry in a dynamically
changing environment.
27. PHARMACEUTICAL PACKAGING
Slide 27
SCHOTT forma vitrum offers pre-fillable syringes made of
glass and COC* polymer
Completely sterile syringe set
Ready for the filling process
Available with luer cone,
luer lock, and staked needle
Designed for bulk
production, non-sterile
Available with staked needle,
luer lock, or luer cone
Unassembled glass barrels,
packed in rondo trays
Syringes available with
integrated luer lock
Automated assembly
technology with in line
process control
Precision molding
Clean room packaging
DMF 18416
forma 3s®
made of glass
SCHOTT TopPac®
Syringes
made of COC polymer
forma 2s
made of glass
*COC = Cyclo olefin co-polymer
28. PHARMACEUTICAL PACKAGING
Slide 28
Worldwide presence
France
Technology Center
Indonesia
USA
Colombia
Brazil
Mexico
Hungary
Switzerland
Germany
China
India
Committed to growth and high standards
600 production lines worldwide
Extensive know-how exchange within group
29. PHARMACEUTICAL PACKAGING
Slide 29
Quality – our key to success
Production processes in GMP environment
Statistical process control &
advanced opto-electronic measuring systems
Compliance with the international standards EP, USP, JP;
certification to ISO 9001, ISO 13485, and ISO 15378
Continuous training of our employees
Continuous improvement at all levels
to achieve zero defects
30. PHARMACEUTICAL PACKAGING
Slide 30
TopLineTopLine products are individually designed to meet advanced
product requirements according to customer specifications.
Enabling you to stay always one step ahead.
Tailor-made solutions for the highest requirementsTailor-made solutions for the highest requirements
Product lines by SCHOTT forma vitrum –
industry quality leader
all products according to USP, EP, JP
ClearLineSCHOTT forma vitrum exclusive forming technology and 100 %
dimensional and cosmetic inspection ensure an excellent
production performance on your filling lines.
Advanced product solutions for superior demandsAdvanced product solutions for superior demands
StandardLineThe SCHOTT forma vitrum StandardLine is our well
established high-level quality complying with international
standards.
High quality complying with international standardsHigh quality complying with international standards
Business Unit Pharmaceutical Systems covers
Business Segment Tubing
Business Segment Pharmaceutical Packaging
A perfect glass tube is the prerequisite to produce a perfect pharmaceutical glass container!
Our worldwide presence is unique in the field of pharmaceutical packaging.
With our 11 production plants we are close to our customers and can offer a global back up of top-quality products. We are the „global local“ partner of the customer.
If you would like to contact us, you will find a SCHOTT forma vitrum sales person or a SCHOTT sales office in practically every country of the world.
Please comment on your specific market(s) in detail.
1. Our policy is to bring products of the highest quality level to the market
2. We follow GMP guidelines: Our production environment corresponds to pharmaceutical standards. Our highly motivated personnel gets trained periodically according to GMP guidelines.
3. The high quality of our products is recognized worldwide and we take big efforts to continuously increase the quality level.
1. We offer three quality options to the customers.
2. Today, vials are offered in 3 quality levels: StandardLine (SL), ClearLine (CL) and TopLine (TL). Ampoules are offered in 2 quality levels: SL and TL. In the future, TL and CL could be extended also to other product types (eg syringes).
3. StandardLine is the quality level of the industry (defect list of Rimkus and PDA). StandardLine is produced by all PP sites (back ups).
4. TopLine solutions are customized products. The cosmetic quality is no longer the main characteristic of TopLine vials.TopLine does not refer to the same properties for ampoules and vials. TopLine ampoules are characterized by low breakforce for easy and consistent opening.