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The FDA Drug Development Process: GLP, GMP and GCP Regulations
 
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This Video provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations. This Video is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements. This webinar will address the basic Drug Development Process, nonclinical trials and human clinical trials. In addition the two major FDA submissions during Drug Development will be covered - the IND submission and the NDA submission. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/JGhy/
Views: 24037 GlobalCompliance Panel
GMP Manufacturing Facilities - From Cell Line Development to Process Development & Tech Transfer
 
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Sue Walker, BioReliance® End to End Solutions team, presents our GMP facility upstream and downstream suites and process development labs. Get Connected! Join Merck Millipore on your favorite social media outlet for the latest updates, news, products, innovations, and contests! Visit us at: http://www.merckmillipore.com/ Join us on LinkedIn: https://www.linkedin.com/company/merck-millipore Join the community on twitter: https://twitter.com/merck_lifesci Do not forget to subscribe to have better access to our videos!
What is GOOD MANUFACTURING PRACTICE? What does GOOD MANUFACTURING PRACTICE mean?
 
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What is GOOD MANUFACTURING PRACTICE? What does GOOD MANUFACTURING PRACTICE mean? GOOD MANUFACTURING PRACTICE meaning - GOOD MANUFACTURING PRACTICE definition - GOOD MANUFACTURING PRACTICE explanation. Source: Wikipedia.org article, adapted under https://creativecommons.org/licenses/by-sa/3.0/ license. SUBSCRIBE to our Google Earth flights channel - https://www.youtube.com/channel/UC6UuCPh7GrXznZi0Hz2YQnQ Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation. All guidelines follow a few basic principles: Manufacturing facilities must maintain a clean and hygienic manufacturing area. Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that affect the quality of the drug are validated as necessary. Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices) Operators are trained to carry out and document procedures. Cross contamination with unlabelled major allergens is prevented. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. The distribution of the food or drugs minimizes any risk to their quality. A system is available for recalling any batch from sale or supply. Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence. Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. In the United States, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing, and most food processing....
Views: 21022 The Audiopedia
GMP Labs Liquid Manufacturing and Bottling Facility
 
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GMP Laboratories of America, Inc. is a custom formulator and contract manufacturer of high quality nutritional supplements and vitamins that offers a complete range of manufacturing and packaging services to help customers bring their product concepts to reality, from initial development to finished product. Some of the services that the company offers are high-speed tablet compression, hard shell encapsulation, powdered drink mix blends, liquids, RTD (ready-to-drink) products, blister card packaging, bottle packaging, powder/pill pouch packaging, and product development in a 100,000 sq. ft. premises located in Anaheim, California. Visit GMP Labs on the web at www.gmplabs.com for a facility tour.
Views: 4816 supplementmfg
Quality aspects in investigational medicinal product developments
 
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Speaker: Tone Agasoster, Norwegian Medicines Agency (NOMA), Norway Session 1: Building quality documentation early during development Quality aspects in investigational medicinal product developments SME workshop: Focus on quality for medicines containing chemical entities 4th April 2014
Views: 634 emainfo
Manufacture of Biopharmaceutical Products
 
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3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organization (CDMO) specialized in the process development and GMP manufacture of biopharmaceutical and cell therapy products from early stages (POC,PC) up to clinical and commercial.The Company offers an integral service for the process development and manufacture of biopharmaceutical products. Visit : http://www.3pbio.com/biologics/cellbanks
Views: 61 Keaty More
Success Factors in Your IND Filing
 
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The successful filing of an Investigational New Drug application (IND) is a pivotal milestone for an emerging pharma company. This webinar is designed to address this crucial topic for the key industry segment. Citing the FDA website for an Investigational New Drug Application, “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” This webinar is geared towards smaller pharma companies filing an IND for the first time but even experienced drug developers could benefit from an overview of the requirements and considerations. The goal of the webinar is to educate and enable our listeners in pursuit of this key objective. While this particular talk is geared towards small molecule active pharmaceutical ingredients (API) and drug products, much of it applies to biologic products as well. The Webinar features three prominent experts in the pharmaceutical development arena and each will highlight a different facet of the IND process. Jennifer Stanek has over 20 years of experience with key roles in CMC regulatory affairs, formulation development and analytical development. She has expertise in the coordination, preparation and management of global clinical trial applications, new marketing registrations, drug master file applications and their life-cycle management. Ms. Stanek began her career at G.D. Searle, moved into CMC consulting and is currently with Takeda where she serves as Director in Global Regulatory Affairs CMC. Jennifer will be providing an overview of the US IND format including an explanation of Modules 1-5, CMC (Chemistry, Manufacturing & Controls) submission timings, FDA meetings (timing, preparation, etc), and other CMC considerations. Dan Weissmueller is the Director of Quality at Regis Technologies. Dan’s experience and expertise include analytical development, process and analytical validation, IND support to Regis’ custom API customers, Drug Master File (DMF) regulatory approvals worldwide and FDA inspections. Dan has been with Regis for about 15 years where he has worked with numerous early phase API developments candidates and been the responsible person for the fillings of 3 approved drugs in over 20 countries. Dan is in the process of completing his Masters’ in Quality and Regulatory Sciences from Northwestern University. Working from the perspective of a custom manufacturing organization (CMO) quality assurance director, Dan has seen both the good and bad in terms of a customer’s preparation for an IND filing. Dan will be highlighting aspects of drug substance development and cGMP scale up as it applies to the IND requirements for small molecule API’s. Topics include the development lifecycle, validation considerations, equipment qualification and risk management. Steve Pondell brings over 30 years of experience in manufacturing and serves as Vice President of CMC at ESSA Pharmaceuticals and previously as a Principal at Integrated Biotech Solutions in Houston, Texas. Steve is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analysis, Phase I product development programs, and cGMP compliance. Steve will focus his talk on the IND requirements for Drug Product along with the corresponding analytical considerations. Topics include container/closure, dosage form (e.g. oral, injectable, etc), analytical method requirements, specifications, validation requirements and product stability.
Webinar: GMP 101 (Intro to Good Manufacturing Practice)
 
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Join Nicolas Danzenbächer and his webinar on Good Manufacturing Practice (GMP) and learn more about GMP guidelines in different countries and comparable regulations. Find out more: https://www.miltenyibiotec.com/products/cell-manufacturing-platform/macs-gmp-portfolio.html MACS Academy: https://www.miltenyibiotec.com/macs-academy Miltenyi Biotec is a global provider of products and services that advance biomedical research and cellular therapy. Our innovative tools support research at every level, from basic research to translational research to clinical application. This integrated portfolio enables scientists and clinicians to obtain, analyze, and utilize the cell. Our technologies cover techniques of sample preparation, cell isolation, cell sorting, flow cytometry, cell culture, molecular analysis, and preclinical imaging. Our more than 25 years of expertise spans research areas including immunology, stem cell biology, neuroscience, and cancer, and clinical research areas like hematology, graft engineering, and apheresis. In our commitment to the scientific community, we also offer comprehensive scientific support, consultation, and expert training. Today, Miltenyi Biotec has more than 2,000 employees in 25 countries – all dedicated to helping researchers and clinicians around the world make a greater impact on science and health.
Views: 42219 Miltenyi Biotec
GMP Labs is a contract manufacturer of dietary supplements
 
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GMP Laboratories of America, Inc. is a custom formulator and contract manufacturer of high quality nutritional supplements and vitamins that offers a complete range of manufacturing and packaging services to help customers bring their product concepts to reality, from initial development to finished product. Some of the services that the company offers are high-speed tablet compression, hard shell encapsulation, liquid products, RTD (ready-to-drink) beverages, powdered drink mix blends, blister card packaging, bottle packaging, powder/pill pouch packaging, and product development in a 90,000 sq. ft. premises located in Anaheim, California. Visit GMP Labs on the web at www.gmplabs.com
Views: 8800 supplementmfg
GMP and regulatory expectations in drug development (DataBlitz 2012)
 
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Louise White provides an overview of the regulatory pathway to the commercialisation of drug products and outlines a framework for development groups. It also provides an introduction to the current expectations for a more scientific and risk-based approach to development and improvement across the drug product lifestyle. DataBlitz on 'From Discovery to Clinical' was held on 1 June 2012.
Views: 325 Swinburne Commons
Key GMP Drivers - Section 2 of 6
 
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Seminar titled, Global Trends in API and Drug Product GMPs, Michael Anisfeld, Globepharm Consulting, presented in September, 2014 at Regis Technologies inc., Morton Grove, IL www.registech.com
Development and Manufacture of Biological Products
 
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3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organization (CDMO) specialized in the process development and GMP manufacture of biopharmaceutical and cell therapy products from early stages (POC,PC) up to clinical and commercial. Website : http://www.3pbio.com
Views: 73 Keaty More
Design Controls - Requirements for Medical Device Developers
 
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The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" – "fast cycle" product development. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/LJLB/
Global Trends in API and Drug Product GMPs: Introduction and Overview - Section 1 of 6
 
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Lecture titled, "Global Trends in API and Drug Product for GMPs" September 2013 Michael Anisfeld of Globepharm Consulting
Harvard i-lab | Understanding Medical Device Development
 
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The healthcare industry is a hot bed of innovation. A convergence of new technologies, connectivity, big data and analytic models are creating a multitude of opportunities to improve health outcomes and reinvent platforms for device and service businesses. Working in a regulated industry requires special considerations that can prove challenging for the uninitiated. From concept generation to launch, this session, led by Aidan Petrie, Chief Innovation Officer of Ximedica, will provide an overview of six essential components of successful product development specific to the development of medical devices and healthcare products. We will start with a discussion around the regulatory considerations that drive many of the activities surrounding each of the development phases and then cover step-by-step each phase of development including an overview of funding milestones and potential sources. Part how-to, part know-how the aim of this short workshop is to equip anyone who is currently trying to bring a product to market or may do in the future with a high level view from experts in the field. Ximedica is the largest product developer the country that is focused solely on the medical space. Our clients range from Fortune 30, VC's, university incubators and everything in between.
AURA cosmetics - corporative video, Serbia
 
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We are AURA, a company producing and distributing cosmetics. We have been building our position as a leader in the region since 1996, and our products have found their places in cosmetic bags in Serbia, Montenegro, Macedonia, Bosnia-Herzegovina, Croatia, Greece, Bulgaria, Ukraine, Romania and The Netherlands. The cosmetics market is cruel everywhere in the world, including the markets in which we do business. In these circumstances it is difficult to compete with the development and marketing budgets of the major international brands. However AURA operates in all its markets with a constant and stable growth index. The reason is our approach to business. First of all, each our product conforms to the highest standards of quality and is in full compliance with the latest trends. If a product does not meet certain criteria, we will simply not place it on the market. That's because we know that we only get one chance to make a good impression on our customers. Our business philosophy is that we have to give our customers a pleasant surprise each and every time. The raw materials for our products are purchased from the world leaders in this field, the very same ones the biggest names in the cosmetics business buy from. Thanks to these contacts we are able to follow technological innovations and we are up to date with the latest trends when it comes to popular colours, formulations and the overall design of cosmetic products. We are constantly improving the quality of our products with trendy, distinctive packaging. And all of this at prices which are affordable for a broad group of consumers. With our business associates, as well as the end users of our cosmetic products, we build a friendly relationship based on monitoring their needs and responding appropriately. We have a workforce of eighty, more than 20 percent of whom are university graduates. Five of them majored in chemistry and three are technologists. Everybody has optimal working conditions, which motivates them to put more energy into their work. The head office in Niš spreads over two thousand square meters of office space. As well as the business premises there are production facilities, a laboratory and a warehouse. There is also a branch office in Belgrade while the AURA GROUP does business in Macedonia, as does AURA BH in Bosnia-Herzegovina. Our laboratory is responsible for research and development of new products as well as quality control. We were certified under the ISO 9001 and ISO 2000 standards in 2003. In 2012, our production facilities were completely renovated in accordance with GMP standards. The production facilities are designed in such a way that we are able to offer a production service for either your private label or for specially developed brands. Come and see for yourself. You'll be pleasantly surprised. Get surprised, each and every time.
Views: 16096 Marina Boskovic
Pharmaceutical Product Lifecycle Management
 
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The presentation gives details of Production Life Cycle begining from lab to final launch, applicable in pharmaceutical and Biopharmaceutical industry.
Views: 3387 Biobridge Healthcare
GMP | PCCA Laboratory Co.,Ltd. Manufacturer of Cosmetics.
 
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website: http://www.pccalabs.com PCCA LABORATORY Co.,Ltd the cosmetic research, development, and manufacturing company, since 2001, has evolved dramatically and has become a leader in quality cosmeceuticals, personal care, health care and nutrition product development and manufacturing with social responsibility and awarded with Good Manufacturing Practice ( GMP ) Certified PCCA LABORATORY Co.,Ltd was established in 2005, initially began its business and research mostly on the field of penetration of emulsion on dermatological, and cosmeceutical products for skin therapeutics. In 2006, we focused on research and development of Enzymatic Technology for skin aging with scientifically proven to have significant beneficial effects on the skin. We are respected throughout the medical community for the incomparable quality of the designed products to treat all skin types; from normal to problematic or chemically treated. We regularly develop our research and development (R&D), equipments and production facilities to enhance a better and higher efficacy of our products. __________________________________________________________________ บริษัท พีซีซีเอ แล็บบอราเทอรี่ จำกัด เป็นบริษัทผลิตครื่องสำอาง ผลิตภัณฑ์เวชสำอาง เพื่อการดูแลปรณนิบัติผิวตั้งแต่ศีรษะจรดปลายเท้า ด้วยผลิตภัณฑ์ที่มีคุณภาพสูงทั้งเพื่อผิวหน้า ผิวกาย และเส้นผมภายใต้แบรนด์ของลูกค้า บริษัทฯได้เปิดดำเนินกิจการมาตั้งแต่ปี 2544 (ค.ศ.2001)อย่างผู้ผลิตมืออาชีพด้วยโรงงานผลิตเครื่องสำอางได้มาตรฐานต่าง ๆ อาทิ Good Manufacturing Practice (GMP),ISO 9001:2008 และ Halal เป็นต้น บริษัทฯ ดำเนินธุรกิจในรูปแบบรับจ้างผลิต (OEM) รับพัฒนาสูตรและวิจัยผลิตผลิตภัณฑ์ พร้อมการจัดหาบรรจุภัณฑ์ ออกแบบฉลากสินค้า และบรรจุภัณฑ์ เราให้บริการอย่างครบวงจร ด้วยทีมงานมืออาชีพ อาทิ นักเคมี นักวิทยาศาสตร์ และเภสัชกรที่มีความรู้ ความสามารถ ทางด้านเครื่องสำอางโดยเฉพาะ เสริมทัพด้วยทีมการตลาดและทีมออกแบบมืออาชีพ ที่จะทำให้ท่านมั่นใจและก้าวสู่ความสำเร็จได้ไม่ยากเลย
Om Bhaskar - GMP placement Process
 
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SPJIMR's Global Management Programme – the GMP (formerly called the PGCIM), is a pioneering initiative that connects our Institution with some of the best global business schools and universities. The programme began in the year 2010 and has grown to be a valuable offering which opens up opportunities for participants to study at SPJIMR and then continue the programme at our international partner schools. GMP began with a partnership between ESB Business School of Reutlingen University, Germany and SPJIMR, after receiving initial recognition and funding from the European Commission. It was initially designed to align with the MBA in International Management offered by ESB Business School. Through GMP today, SPJIMR builds on its approach to globalisation, which is essentially to create a multinational faculty and alumni base as well as develop partnerships with noted foreign educational institutes. A global curriculum, a rich faculty base and a diverse learning experience through courses, simulations, projects, internships and placements in international destinations make GMP stand out as one of the best known global faces in India. Today we have our alumni working at international destinations in organisations like - World Bank, ING Bank, ABN AMRO Bank, Apple, Airbus Helicopters, Amazon EU, Credit Suisse, E.ON, PWC, E&Y, Deloitte, Crane Co., Capillary Technologies, Rocket Internet, IBM, TCS, Daimler, Decathlon, General Electric, to name a few. Some of the positions held are Chief Product Officer, Loyalty & Retention Manager, Pricing Manager, Finance Controller and Group Account Manager. Some of the highlights of the Global Management Programme are Exposure to multinational learning environment and diverse cultures; Gateway to M.Sc. in management with specialisations – an MBA equivalence for applicants without work experience; International MBA Degree from reputed Business Schools; GMP Certification from SPJIMR, covering General Management courses Specialisations and Electives offered by International Business Schools; Company-linked Master Theses; International Internships and Graduation; Support and training from Career Cell offered by International Business Schools; Creating global managers to meet the international aspirations. Building a global mindset for doing business with global impact; International exposure and opportunity to experience diverse cultures.
Views: 407 SPJIMR GMP
Good Manufacturing Practice
 
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Paper:-Product development Part 2 Subject:-Pharmaceutical Science
Views: 19 Vidya-mitra
Coriolis: A trendsetter in innovative biopharmaceutical product development
 
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Coriolis is the leading independent contract research organization dedicated on formulation development of biopharmaceuticals. We transform our customer’s vision on new molecules into successful products from first-in–human to commercial.” Coriolis competence is integrated into 3 different business units for liquid formulation including high concentration, lyophilization development and analytical services under R&D and GMP. Our customers are big pharma as well as midsize and small biotech companies, from all over the world (equally spread between the US and EU about 15% are located in Asia). http://www.coriolis-pharma.com
Views: 2214 WebsEdgeHealth
PPD® Laboratories Bioanalytical Lab Tour
 
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Our people are at the heart of PPD’s bioanalytical capabilities. Discover how the PPD® Laboratories bioanalytical lab team has been dedicated to providing the highest-quality data for more than 30 years: http://ppdi.com/bioanalytical.
Views: 1535 PPD
How a CMO can help your product development - Mr A W Willemse
 
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CPHI 2013 BioConnection is a Dutch contract services and manufacturing organization for the development and production of injectable (bio)pharmaceutical products. We have the means and expertise to bring your invention from the lab to the clinic and/or to the market. Due to our unique setup and best-in-class European network of development and manufacturing partners we are able to provide you with tailor made solutions with unmatched flexibility. Our approach ensures a seamless development and manufacturing chain for your product. We have access to various GMP manufacturing facilities across Europe that are all in compliance with the EMA and/or the US-FDA guidelines. The cornerstones of our CMC services are: Drug Product development (formulation, analytics, freeze-dry cycle), fill & finish and freeze-drying at clinical and commercial scale. We are currently expanding our capabilities with the development and GMP manufacturing of complex formulations such as microspheres, liposomes and nanoparticles. In this network Sinensis Lifesciences is an important player delivering QC-Analysis, microbiology, GMP manufacturing and analytical development services. During our presentation both BioConnection and Sinensis LifeSciences will present their capabilities to contribute to your successful project. - See more at: http://www.cphi.com/europe/networking/free-seminars#sthash.nM7Ft8Pf.dpuf
WEBINAR: Overview of CMC Analytical and Stability Studies Required for Biopharmaceutical Products
 
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In around 40 minutes, this webinar will cover: • Why developing biological/biotech/biosimilar products is so challenging • What world-wide regulations detail CMC analytical study requirements • The success factors in developing and commercialising biotech/biosimilar products
ENGLEWOOD LAB, Contract Manufacturer Cosmetics & Skincare Product
 
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Englewood Lab, LLC is a product development contract manufacturer with a focus on innovation and quality. We specialize in Over-the-Counter (OTC) and treatment skin care products that have unique textures while meeting regulatory standards. Innovation and quality are team efforts at Englewood Lab, with each discipline contributing knowledge and experience from their respective areas of expertise.
Views: 10702 ENGLEWOOD LAB
Complex Pharmaceutical Product Development, Generics and Biosimilars
 
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Formulating a Program for Formulation Development of Complex Products
Development and Delivery of Pharmaceutical Products  (CMC) - MaRS Best Practices
 
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Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and critical. Let Dr. Colin Minchom take you through the aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process. Watch this video to learn about the pharmaceutical product development which includes objectives of formulation, cost-effective strategies to reach key milestones and more. MaRS -- Building Canada's next generation of global technology companies. marsdd.com
Cell Therapy webinar:  Regulatory requirements to commercialize cell therapy
 
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www.gelifesciences.com/CellTherapy Due to evolving science and unique properties of cell or tissue based products, GMP development and production for cell therapy products have been challenging, especially in clearly defining the quality attributes, - safety, identity, purity, stability, potency/biological activity, and in defining what tools to use to achieve these quality attributes.
Working in the Definiens Product Development Team
 
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Watch this video to get an impression on how it's like to work at Definiens, in the product development department. Lean back and enjoy!
Views: 2449 DefiniensLifeTV
Webinar: Intro to the Product Development Protocol (Part 1, FDA Series)
 
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(1st of 4-part series) Jeff Skiba addresses various components of FDA product development protocol such as product strategy, design and development, verification and validation, launch plan, design transfer and production.http://asbtdc.org - Subscribe Now! https://www.youtube.com/subscription_center?add_user=ArkansasSBTDC The Arkansas Small Business and Technology Development Center is funded in part through a cooperative agreement with the U.S. Small Business Administration. All opinions, conclusions or recommendations expressed are those of the author(s) and do not necessarily reflect the views of the SBA. All ASBTDC programs are extended to the public on a non-discriminatory basis.
Views: 159 ArkansasSBTDC
Pharmaceutical Product Development
 
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Pharmaceutical Product Development, LLC is a global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. The company’s clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD is mainly known for conducting drug development for its clients, it also invests in developing new products through its compound partnering program. This video is targeted to blind users. Attribution: Article text available under CC-BY-SA Creative Commons image source in video
Views: 1298 Audiopedia
Theon Pharmaceuticals Ltd, Baddi-Best Third Party Contract Manufacturing Pharmaceutical formulations
 
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Theon Pharmaceuticals Ltd Since its inception in 2005, Theon Pharmaceuticals Ltd., a WHO-GMP & ISO 9001:2008 certified company is a rapidly growing professionally managed Indian Pharmaceutical Company and is now effectively harnessing global opportunities to fortify its international presence. Theon’s State of the art modern facilities are spread over 4.5 Acres, located in lush green, excise free zone of Nalagarh in the state of Himachal Pradesh. This excise free zone is a hub of leading pharmaceutical companies of India as it provides a cost competitive edge over manufacturing units operating in other parts of India. The Company boasts of an impressive product list inclusive of niche DCGI approved formulations to meet all customer needs. It is presently a co-producer to leading pharmaceutical companies of India. • WHO - GMP and ISO 9001:2008 Certified Company • Leading Contract Manufacturing Company in the Country • State of the art Infrastructure • Dedicated and Fabricated Blocks for General, Betalactam & Cephalosporins • Automated Machines & High - Speed packing lines • Dedicated Modular Labs complying GLP norms • 100% Excise Free Zone • Exporting to ASIAN, AFRICAN & CIS Countries • NABL accredited Modular laboratories with latest sophisticated instruments Including UPLCs Theon has marked its presence globally by exporting its products to Africa, Central Asia, CIS, French West Africa, Latin America and South East Asia. We have an array of Certification. • WHO-GMP • PPB - Kenya • NDA - Uganda • FMHACA - Ethiopia • TFDA - Tanzania • MOH - Vietnam • DPM - Ivory Coast • MOH - Sri Lanka • MOH – Afghanistan • FDA- Philippines • GMP • Neutral Code (for exports) • Dietary Supplement License • Non - Conviction Certificate • ISO 9001: 2008 • NSIC - CRISIL Rating: SE 1A & BBB+ The Company has dedicated & segregated blocks for General, Penicillins (ß-lactam) & Cephalosporins dosages in the form of Tablets, Capsules, Ointments, Sachets, Injectables and Dry Syrups covering all major therapeutic segments. To carry out Real Time & Accelerated Stability Studies as per ICH guidelines, the Company maintains separate dedicated R&D laboratories and stability chambers & laboratories. For strict compliance of Good Laboratories Practices (GLP's), the Company has latest sophisticated instruments in its in-house chemical, instrumental & microbiological laboratories. Theon aims at carving a place for itself in the Indian Pharmaceutical market with specialization in new and niche molecules thereby adding value for their clients as well as customers. Theon's Global Presence Streamlining the export vision at Theon, a dedicated Export regulatory department team has been set up for complying with international audits and providing complete export documentation including COPP and dossier preparations as per CTD format. Operating in total compliance with c-GMP norms, Theon's manufacturing unit has been granted certifications by PPB - Kenya, NDA - Uganda, FMHACA - Ethiopia, TFDA - Tanzania, MOH - Vietnam, DPM - Ivory Coast, MoH - Sri Lanka, MOH - Afghanistan and several others in pipeline. Theon is currently catering to Africa, South East Asia, Central Asia, French West Africa, CIS, Latin America, Asia Pacific and many more and we endeavour to become the world class pharmaceutical manufacturer for India & neighboring countries and to assist in the development of quality products by providing superior performance with high class products in right budget. Salient Features • Built up area of 1,75,000 sq. ft with separate areas for production and stores • Quality Control, HVAC, Utilities and Administration • Separate entry and exit for man, material & service personnel for both • Designed and built as per vertical flow concept of man – material movement • c-GMP compliant latest manufacturing equipments • NABL accredited Modular laboratories with latest sophisticated instruments Including UPLCs • Highly skilled, dedicated and experienced technical staff • Automated access control system and fully equipped cameras • Immaculate environmental monitoring, calibration and validation programme Quality & innovation are the hallmark of Theon. At Theon, we strongly support Environmentalism, and keeping in mind the same, we use innovative method & technology to have highest standards of Safety, Environment and Health in our manufacturing processes. A passion for innovation…. A commitment to excellence…. A reputation for reliability…. THEON PHARMACEUTICALS LTD. For healthy lives……..
Views: 95991 Naveen Thakur
From idea to medicine: drug development at Roche
 
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Roche is a place for pioneers because we are doing now what patients need next. We have more than 18,000 employees working on research and development to deliver medical innovations that can help to improve lives of millions people. Following the first discovery of a molecule by our researchers, it takes more than 12 years and many steps before a doctor can prescribe our medicines whenever needed. Watch this video to learn more about the drug development process at Roche. To learn more about Research & Development (R&D) at Roche, visit https://www.roche.com/research_and_development.htm. Subscribe to our YouTube channel now: https://www.youtube.com/user/roche?sub_confirmation=1 Get in touch with us: https://www.roche.com/ https://www.facebook.com/RocheCareers https://www.linkedin.com/company/roche https://twitter.com/roche Roche has been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally. Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. For more information and insights visit: https://www.roche.com/
Views: 60716 Roche
Advanced Pharmaceutical Manufacturing
 
01:03:26
There are a number of challenges that the industry faces in order to transition towards more competitive, systematic and efficient manufacturing. Regulatory authorities have recognized the deficiencies of pharmaceutical product manufacturing and aim to enhance process understanding through Quality by Design (QbD) and Process Analytical Technology (PAT) tools. As a result of this current effort to change the mindset in order to mimic the rest of the chemical industry, an additional transition is becoming more and more appealing: transition from batch to continuous production mode. However, continuous manufacturing requires detailed process understanding in terms of the evolution of all critical material properties as a function of its operating parameters and environmental conditions. Once process knowledge is translated into models, computer aided dynamic simulation tools will allow the design, analysis and optimization of continuous integrated processes. In this talk I will discuss the work that has been done in my lab towards the development of an integrated platform that will enable the efficient flowsheet simulation and analysis, the assessment of design alternatives, the feasibility analysis of the production line, and the control and optimization of process design and operations. The developed flowsheet model includes modules for all the necessary unit operations, namely powder feeding, mixing, roller compaction, tablet press and milling integrated to represent a tablet manufacturing line. Models used to represent each unit operation vary from empirical, first-principle or hybrid. Population balance models are developed in order to track the composition and particle size changes throughout complex powder processes dynamically. The developed flowsheet simulation is used to predict the propagation of upstream disturbances to final product quality, the assessment of recycle stream benefits, the identification of process integration bottlenecks and evaluation of different control strategies in order to retain the process within its design space. In addition, global dynamic sensitivity analysis is performed to identify critical process parameters not only within each unit operation, but also between different processes. Finally, simulation based optimization techniques enable the identification of the optimal operating conditions, as well as the optimal design sequence which leads to pharmaceutical tablets with desired characteristics. This work aims to merge knowledge, experience, experimental results and modeling tools for developing a dynamic simulation platform that will enable the safe implementation of the transition towards continuous pharmaceutical manufacturing. Biography: Marianthi Ierapetritou is a Professor and Chair in the Department of Chemical and Biochemical Engineering at Rutgers University in Piscataway, New Jersey. Dr. Ierapetritou’s research focuses on the following areas: 1) process operations; (2) design and synthesis of flexible production systems focusing on pharmaceutical manufacturing; 3) modeling of reactive flow processes; and 4) metabolic engineering with focus on biopharmaceutical production. Her research is supported by several federal (NIH, NSF, ONR, NASA) and industrial (BMS, J&J, ExxonMobil, Honeywell, Cardinal Health) grants. Among her accomplishments are the Outstanding Faculty Award, the Rutgers Board of Trustees Research Fellowship for Scholarly Excellence, and the prestigious NSF CAREER award. She has more than 180 publications, and has been an invited speaker to numerous national and international conferences. Dr. Ierapetritou obtained her BS from The National Technical University in Athens, Greece, her PhD from Imperial College (London, UK) in 1995 and subsequently completed her post-doctoral research at Princeton University (Princeton, NJ) before joining Rutgers University in 1998.
Views: 41782 APMonitor.com
SAFA FOOD Gluten Free White Pitta Bread Dublin Ireland (HD1080P)
 
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www.safafood.com https://www.facebook.com/SafaFoods Did you know Safa Food is one of the largest and most advanced and the only Pitta bread bakery's in Ireland, spanning three major sections in one facilities: flat breads & Gluten Free, Sugar Free Confectionery. With rapidly changing trends in consumer needs our Innovation and Research & Development teams continuously work with customers and consumer forums to provide innovative offerings for today’s market. Our product Development capabilities and processing expertise coupled with Safa Foods' research and marketing teams have ensured that our brands East West Bakery are leaders in the European manufacturing bakery sector. _______________________________ #SAFA FOOD QUALITY CONTROL Quality Control is a responsibility that Safa Food Limited take very seriously, hence the independent certification by one internationally recognized standards, the BRC Food Standard. Through pre-delivery inspections, supplier and manufacturer audits, adherence to the BRC Food Grade (Higher Level) Grade A standard, HACCP and in-house Quality Assurance Management System, including product traceability, Quality Assurance is the cornerstone of our company culture. BRC standards requires the adoption and implementation of HACCP, a documented and effective quality management system and the continuous control of environment standards, products, processes and personnel. Safa Food uses a rigorous Quality Management System to assure the best production practices. QMS incorporates comprehensive and best practice procedures covering areas such as HACCP, continual improvement, GMP, new product development, calibration, hygiene, safety, environmental. To meet this objective, it is the policy of Safa Food to: Implement and maintain the BRC Food Grade standard Implement and maintain a documented Quality Management System Implement and maintain HACCP programme Implement and maintain industry recycling through Repak Implement and maintain a system of product traceability Purchase goods from suppliers who operate similar Quality Management Systems Comply with local and government environmental policies Motivate and encourage all staff on an ongoing basis to recognize the importance of quality as part of outstanding customer service __________________________
Views: 224 KarwanSuhrabiVEVO
GMP Change Control Management Software Video
 
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This video demonstrates the functionality of GMP Change Control Management Software developed by www.gmpsop.com
Views: 1166 Sami Power
GMP Product Complaint Investigation Software Video
 
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This video demonstrates the functionality of GMP Product Complaint Investigation Software developed by www.gmpsop.com
Views: 169 Sami Power
Plenary Session: Cell Therapy Product Development
 
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As more products head into later stage clinical development inevitably there will be successes and setbacks along the way. How do we educate key stakeholder groups so that expectations are realistic and informed, thus avoiding volatility and overreaction to positive and negative data events? What do we see as the key clinical issues we need to address in some of the larger indications so we can help prospective partners and investors better understand the commercial opportunities around cell therapy products? This panel of industry and clinical experts will examine these issues and offer insight into how these challenges will be addressed over the next 3-5 years. Moderator: Mark Stevenson, EVP & President, Life Science Solutions, Life Technologies, A Thermo Fisher Brand Panelists: Gwendolyn Binder-Scholl, Ph.D., EVP, Head of Clinical & Regulatory Development, Adaptimmune Christian Homsy, M.D., CEO, Cardio3 BioSciences Jay Siegel, M.D., Chief Biotechnology Officer, Head of Scientific Strategy & Policy, Johnson & Johnson Donna Skerrett, M.D., Chief Medical Officer, Mesoblast Gil Van Bokkelen, Ph.D., Chairman & CEO, Athersys For more information on the 2014 Stem Cell Meeting on the Mesa visit www.stemcellmeetingonthemesa.com
Product Development Using the NDA 505(b)(2) Approval Pathway
 
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The 505(b)(2) NDA pathway is increasingly utilized to bring improved and differentiated products to market faster and more cost effectively. 505(b)(2) products often utilize enabling technologies to create better medicines through new formulations, new dosage forms, and new combinations which can result in up to 7 years of market exclusivity. Camargo and Capsugel discuss 505(b)(2) challenges, recent regulatory updates, and case studies demonstrating successful application of enabling technologies in 505(b)(2) product development.
Views: 664 Capsugel
global generic drug product development by Dr  V B Reddy  T part - 2
 
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A seminar on the topic "Global generic drug product development" was given by Dr. V.B.Reddy for the professionals learning training programme called PILS (Professional Inputs & Learning Skills).
Views: 77 Seenu Murthy
Cosmetics Good Manufacturing Practice (GMP) - ISO 22716
 
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http://www.ceway.eu Cosmetic products placed on the EU market have to be produced according to the good manufacturing practice or GMP standard ISO 22716. This clip presents the cosmetics good manufacturing practice and standard ISO 22716. Cosmetics good manufacturing practice is one of the pillars of the EU cosmetics regulation 1223/2009. Compliance with good manufacturing practice is presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union. This harmonized standard is ISO 22716. ISO 22716 is an international standard used in various countries, and it has links to many other cosmetic regulations around the world. ISO 22716 gives guidance for the production, control, storage and shipment of cosmetic products. It deals with all aspects of the supply chain of cosmetic products. It covers the quality aspects of the products, but it does not cover: safety aspects for the personnel engaged in the plant, protection of the environment, and it is not applicable to research and development activities. Good manufacturing practice GMP standard ISO 22716 provides guidance in a number of areas, which can be broadly divided into 5 categories: personnel, premises and equipment, production, quality control, quality systems.
Institute of Good Manufacturing Pratices India (IGMPI)
 
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Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and a member (as a higher/professional education Institute) of Quality Council of India (QCI), Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential and most dynamic element of industries like pharmaceutical, Biotechnology, cosmetic, Ayurveda, Homeopathy, medical device and food manufacturing. Keeping self-updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices. With its mission of "Knowledge Dissemination and Human Resources Development in pharma and healthcare Industries", IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training & distance learning platform provider for pharma and healthcare professionals and students in the areas of Good Manufacturing Practices, Quality Assurance & Quality Control; Regulatory Affairs, Intellectual Property Rights, Clinical Research, Pharmacovigilance, Nanotechnology Medical Writing, Medical Coding, Drug Discovery and Development, Public Health and Hospital Management, Pharma Marketing and Pharma Product Management. The courses have been structured and designed under the guidance of field experts and thus promise to impart theoretical and practical knowledge about the defined subjects. Based on high standard of quality, the training programmes have been duly approved and certified by Quality Council of India, Government of India.
Views: 3810 IGMPI
How to Prepare for an Interview
 
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PPD recruiters provide tips and guidance for interviews with our company. Tips include how to dress and act professionally, advice on reviewing the job description and determining how your strengths and experiences can add value to PPD.
Views: 9429 PPD
IMC business aryevadic apneya nirog jivan paya gold medal and national achievement award winner
 
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Company for outstanding quality research development company w.h.o gmp gpp 100 %organic product HACCP ,halal , herbal contact no.9199562157,7250385600
Views: 50 SANJAY KUMAR
Development of a drug product by Dr  Orna Dreazen  Nextar
 
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Development of a drug product By Dr. Orna Dreazen- Nextar
R-Pharm Germany: Product and Process Development Center
 
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High containment facility for clinical, pilot or small scale GMP manufacturing ranging from 0.5kg up 20kg per Batch (OEB 4/5)
Panel: Accelerating Regulatory Development of Advanced Therapy Medicinal Products for Patients
 
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ACCELERATING REGULATORY DEVELOPMENT OF ADVANCED THERAPY MEDICINAL PRODUCTS FOR PATIENTS IN NEED This panel features distinguished regulators from the U.S., EU and Japan as they share their views on how different expedited programs are supporting innovation and accelerating advanced therapy product developments for patients with significant unmet needs. Panelists will discuss how to improve the regulatory process and lessons learned from recent experience in this rapidly emerging field, including real world evidence generation. Looking to the future, panelists will share ideas on how to bridge the gap with science and the next step in a product life-cycle. Both in terms of process and scientific review and advice, panelists will be asked whether there are things industry could do better, and whether there are tools that could benefit all regions to improve efficiency in the regulatory authority/sponsor dialog. Sponsored by Cell and Gene Therapy Catapult and Janssen R&D Chair: Jacqueline Barry, Ph.D., Chief Clinical Officer, Cell and Gene Therapy Catapult Speakers: Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) Yoshiaki Maruyama, Ph.D., Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA) Gopalan Narayanan, M.D., VP, Disruptive Biologics, Voisin Consulting Life Sciences (VCLS) Paula Salmikangas, Ph.D., Director of Biopharmaceuticals and ATMP, NDA Advisory Board Daisaku Sato, Ph.D., Director, Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (MHLW)

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