Oxford Life Sciences offers a complete suite of medical device, biologics/biotechnology, and pharmaceutical lifecycle services. They provide individual consultants and project teams to help clients throughout the entire product lifecycle from development to post-market surveillance. Their consultants can fill knowledge gaps or work independently under a client's direction in areas like quality assurance, regulatory affairs, clinical affairs, research and development, manufacturing, validation, and more. Oxford Life Sciences recruits consultants for a variety of roles across the pharmaceutical, biotechnology, and medical device industries.
ISO Consulting Services offers ISO 9001 standard consulting services in Australia which will support an effective quality management system for your business and it will also help you to the meet the requirements of customers. For more details visit at www.isoconsultingservices.com.au.
Sherrie Webb - Common Industry Audit, Producer UpdateJohn Blue
Common Industry Audit, Producer Update - Sherrie Webb, Director Animal Welfare, National Pork Board, from the 2015 Pork Industry Forum, March 5-7, 2015, San Antonio, TX, USA.
More presentations at http://www.swinecast.com/2015-national-pork-industry-forum
What is ISO 9000?
Quality is something every company strives for and is often times very difficult to achieve. Complications concerning efficiency and quality present themselves everyday in business, whether an important document cannot be found or a consumer finds a product not up to their expectations. How can a company increase the quality of its products and services?
(The answer is ISO 9000)
Work of ISO 9000.
ISO 9000 is set up as a collection of guidelines that help a company establish, maintain, and improve a quality management system. It is important to stress that ISO 9000 is not a rigid set of requirements, and that organizations have flexibility in how they implement their quality management system. This freedom allows the ISO 9000 standard to be used in a wide range of organizations, and in businesses large and small.
ISO stands for International Organizational for Standardization. It is an international body which consists of representatives from more than 90 countries. The national standards bodies of these countries are the member of this organization.
BIS(Bureau of Indian Standards) is the Indian representatives to ISO.
ISO and IEC(International Electro Technical Commission) operate jointly as a single.
These are NGO Which exist to provide common standard on international trade of goods and services.
ISO 9000 series has five international standards on quality management which are listed below:
ISO 9000
ISO 9001
ISO 9002
ISO 9003
ISO 9004
ISO Consulting Services offers ISO 9001 standard consulting services in Australia which will support an effective quality management system for your business and it will also help you to the meet the requirements of customers. For more details visit at www.isoconsultingservices.com.au.
Sherrie Webb - Common Industry Audit, Producer UpdateJohn Blue
Common Industry Audit, Producer Update - Sherrie Webb, Director Animal Welfare, National Pork Board, from the 2015 Pork Industry Forum, March 5-7, 2015, San Antonio, TX, USA.
More presentations at http://www.swinecast.com/2015-national-pork-industry-forum
What is ISO 9000?
Quality is something every company strives for and is often times very difficult to achieve. Complications concerning efficiency and quality present themselves everyday in business, whether an important document cannot be found or a consumer finds a product not up to their expectations. How can a company increase the quality of its products and services?
(The answer is ISO 9000)
Work of ISO 9000.
ISO 9000 is set up as a collection of guidelines that help a company establish, maintain, and improve a quality management system. It is important to stress that ISO 9000 is not a rigid set of requirements, and that organizations have flexibility in how they implement their quality management system. This freedom allows the ISO 9000 standard to be used in a wide range of organizations, and in businesses large and small.
ISO stands for International Organizational for Standardization. It is an international body which consists of representatives from more than 90 countries. The national standards bodies of these countries are the member of this organization.
BIS(Bureau of Indian Standards) is the Indian representatives to ISO.
ISO and IEC(International Electro Technical Commission) operate jointly as a single.
These are NGO Which exist to provide common standard on international trade of goods and services.
ISO 9000 series has five international standards on quality management which are listed below:
ISO 9000
ISO 9001
ISO 9002
ISO 9003
ISO 9004
PENDIDIKAN DESAIN KRIYA
ditengah Masyarakat Urban
(Paparan Ringkas) Rabu, 22 Oktober 2014
Pemateri: S a r d i
Praktisi Batik Pemula dengan ZPA (Zat Pewarna Alam)
Jln. Kaliurang Km. 12 Yogyakarta
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
PENDIDIKAN DESAIN KRIYA
ditengah Masyarakat Urban
(Paparan Ringkas) Rabu, 22 Oktober 2014
Pemateri: S a r d i
Praktisi Batik Pemula dengan ZPA (Zat Pewarna Alam)
Jln. Kaliurang Km. 12 Yogyakarta
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
IDSC is an interdisciplinary group of 40 ex-pharma leaders averaging 25-years of big-pharma, biotech, and academic experience. Our clients come to us for drug discovery and drug development interim leadership, consulting, fully integrated collaborations, due diligence, molecular modeling, and outsourcing management. Because we are a fully integrated drug discovery, preclinical development, and clinical development partner, we help our biotech, VC, academic, and pharma clients get from early discovery to IND filing and through phase I clinical trials in all major therapeutic areas and on to NDA in antibacterials, CNS, and oncology.
Service Overview
Site management services to CRO and SITE:
A) Pre initiation
Identification of Potential Sites
Faster Feasibility
Site set up, supplies and other infrastructure needs
Regulatory and IEC/ IRB communications
Rapid negotiation of CTA
Setting up Standard Operating Procedures (SOPs)
B) During Study Duration
Provide dedicated trained and experienced CRCs (Clinical research coordinators)
Patient recruitment & retention Support
Maintenance of essential documents
Source documentation as per ALCOA standards (Attributable, Legible, Contemporaneous, Original & Accurate
Regular IP (Investigational Product) accountability and storage
Completion of CRF’s within timelines
Faster query resolution
Reporting of AE, SAEs within timelines
Support Monitoring visits and Quality Assurance audit action items.
Patient visit Follow Up and compliance assistance
Preparation of site for monitoring and audits/ inspections
C) Post Close out
· Archiving of site results and documents
Site Identification
Faster Feasibility
Ready Sites
DCN Diagnostics. Design and Development of Lateral Flow Assay SystemsBrendan O'Farrell
DCN Diagnostics designs and develops rapid assay systems for medical and veterinary diagnostics, bio-defense, agriculture, environmental testing and other market segments. DCN's service offering includes contract assay development, education and training courses in lateral flow technologies, industrial design and mechanical engineering services related to development of related devices for rapid diagnostics. Our specialties include lateral flow, flow through and microfluidic assay formats, and we have developed qualitative, quantitative, visual or fluorescent assay systems. DCN's ISO 9001:228 and EN 13485 compliant quality system is set up to allow us to deliver the full FDA compliant design history file. Our process and unique teams of highly experienced development scientists working alongside our engineering teams allow us to deliver the product, not just the parts. DCN Diagnostics is the sole supplier of cellulose nanobead technology for lateral flow diagnostics outside of Japan and can supply technical consulting and development assistance to companies wishing to develop and manufacture highly sensitive and quantitative lateral flow assays using the NanoAct (tm) beads. Our experience in multiplexing and joint ownership in the Symbolics patents covering aspects of multipex arraying in lateral flow formats allows DCN to assist our clients in creating highly unique and functional assays for any environment or application. DCN also provides our unique UltraGold (tm) colloidal gold for use in lateral flow assays. DCN's 40nm gold colloid is highly controlled, very stable and designed specifically for use in lateral flow and flow through assays.
USG Science Professionals deploys ambitious scientists on exciting projects. Our involvement allows companies to turn their challenges into practical solutions.
In R&D, production and distribution, our focus areas, we can support from A to Z. For both operational and strategic challenges, from advice to implementation. Our commitment to results is manifest in all our service models.
1. Oxford Life Sciences Services
Oxford Life Sciences offers a complete suite of medical device, biologics/biotechnology, and pharmaceutical
lifecycle services, from individual consultants to project teams to strategic outsourcing.
Our individual consultants and project teams deliver the business knowledge and hard-to-find technical
expertise our clients need for the entire tenure of a product’s lifecycle, from development to post-market
surveillance. Our consultants can fill knowledge gaps on current teams, or work independently under our
clients’ direction as process engineers, quality assurance professionals, regulatory and clinical affairs associates,
validation engineers, and more.
Our recruiting services are available for, but not limited to, the following areas:
• Research & Development: Oxford Life Sciences provides research and development (R&D) consultants
for the pharmaceutical, medical device, and biotechnology industries, and we fill the majority of the R&D
projects for which we compete.
• Clinical Affairs: Oxford Life Sciences provides highly skilled clinical affairs consultants for innovative
research in the pharmaceutical, biotechnology, and medical device industries; clinical research organizations;
as well as research hospitals and universities.
• Regulatory Affairs: In a regulated environment, when so much is riding on the time it takes for a product to
reach the market, a flawless strategy and execution is imperative - let Oxford Life Sciences help set you on a
path for success.
• Manufacturing: If you’re looking for help finding your next product manufacturing engagement, or need a
full-scale solution for designing your organization’s production methods, Oxford Life Sciences can help.
• Validation: Our validation consultants assist clients with installation and commissioning by writing and
executing Standard Operating Procedures (SOPs), Master Validation Plans (MVPs), Design Qualification
(DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
protocols, and more.
• Quality Assurance: Each year Oxford delivers hundreds of quality assurance consultants to ensure clients’
highly regulated products achieve unparalleled attention to quality.
• GxP Quality & Compliance: As clients become more reliant on technology based systems, they
look to Oxford Life Sciences’ GxP quality & compliance consultants to ensure their systems meet
21 CFR Part 11 and Annex 11 requirements.
• Facilities: Whether you’re a client who requires a project manager for your new equipment
installation, or a consultant who specializes in facility design, look to Oxford Life Sciences.
oxfordlifesciences.com
XFORDO
The Right Talent. Right Now.
