ABALL_PDA
1 like164 views
Anthony Ball, a study director at Toxikon Corporation, presented a poster at the 2014 PDA/FDA Virus & TSE Safety Conference on the use of bacteriophage to simulate viral ingress into sterile medical device fluid paths. The conference brought together regulators and industry professionals to discuss product safety related to viruses and transmissible spongiform encephalopathy. Mr. Ball's poster proposed a simple solution for medical device viral ingress testing using bacteriophage models.
1 of 2
Download to read offline
Recommended
Quality In Biopharma Press Release
Quality In Biopharma Press ReleaseStewart K. Jason
油
The second annual North Carolina Quality in Biopharma Conference will be held May 20-21, 2010 at the Bioprocessing Technical Education Center at North Carolina State University's Centennial Campus in Raleigh, North Carolina. The focus of the two-day event will be environmental monitoring in biomanufacturing, with talks, discussions, and networking for professionals in quality, manufacturing, environmental microbiology, and process engineering. James C. Greenwood, president and CEO of the Biotechnology Industry Organization, will speak about how the biotechnology industry is being impacted by legislation and shaped by public policy.Risk of objectionable microorganisms in biopharmaceuticals
Risk of objectionable microorganisms in biopharmaceuticalscomplianceonline123
油
This webinar discusses objectionable microorganisms in biopharmaceuticals and how to mitigate their risks. It aims to help participants understand how regulators define objectionable microorganisms and determine how objectionable certain microbes are. The webinar covers recent recall data related to microbiological contamination, definitions of objectionable microorganisms, how to assess the risk posed by microbes found in processes or products, examples of objectionable microorganisms, and how to establish a risk assessment strategy. The target audience includes those in manufacturing, quality assurance, microbiology, and regulatory and compliance roles.Objectionable microorganisms within and beyond regulations
Objectionable microorganisms within and beyond regulationsStephen Mc Grath PhD
油
Review of the regulatory guidance and best practice with respect to objectionable microorganisms in pharmaceutical productsAmy Wakeman Resume
Amy Wakeman ResumeAmy Wakeman
油
Amy Wakeman has over 5 years of experience working in medical device and healthcare fields at Dow Corning Corporation. She has experience formulating silicone-based materials, measuring physical properties, analyzing and presenting data, and characterizing raw materials. Additionally, she has led extraction studies to assess extractables profiles for pharmaceutical tubing and participated in bacterial testing. She received a Bachelor of Science degree in Chemistry with a minor in Biology from Saginaw Valley State University in 2016.B_Hernandez Resume
B_Hernandez ResumeBianca J Hernandez
油
Bianca J. Hernandez has over 6 years of experience in biotechnology, chemistry, and forensic sciences. She holds a Bachelor of Science in Molecular Biotechnology and is pursuing a Bachelor of Industrial Engineering. Her experience includes work at Amgen as an Associate Scientist performing experiments using various analytical techniques such as FTIR and SEM. Previously, she worked at Lilly del Caribe as a Biotechnology Operator overseeing purification processes and at Cristalia Premium Water as a Quality Control Technician monitoring water quality. She is bilingual in English and Spanish with strong computer and problem-solving skills.Pharmaceutical Microbiology West Coast 2018
Pharmaceutical Microbiology West Coast 2018Dale Butler
油
The document outlines the agenda for the 2nd Annual Pharmaceutical Microbiology West Coast conference on June 7-8, 2018 in San Diego. The conference will focus on key challenges and developments in pharmaceutical microbiology, with sessions on environmental monitoring, rapid methods, data integrity, aseptic processing, regulatory updates, and microbial identification. Speakers will present case studies and discuss issues like microbiological deviations, contamination control, disinfectant efficacy testing, and applying pharmaceutical microbiology technologies to other fields like human diagnostics. Workshops on June 6 will address risk-based environmental monitoring and microbial contamination control technologies.Article: On the Cusp of Curing Disease
Article: On the Cusp of Curing DiseaseMerck Life Sciences
油
Welcome to the M Lab Collaboration Centers where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlabBacti barrier service offering for schools 
Bacti barrier service offering for schools David Baskey
油
The document discusses a biodecontamination system called BactiBarrier that aims to reduce illness and infection in school systems. It notes that schools can be breeding grounds for bacteria and viruses due to close contact between students. BactiBarrier provides a 4-step process: 1) assessment of contamination levels via ATP/swab testing, 2) biodecontamination using an EPA-approved disinfectant, 3) long-term antimicrobial protection, and 4) follow-up testing. Case studies show BactiBarrier significantly reduces contamination in schools over regular cleaning methods.Viral Risk Mitigation - A Global Regulatory Perspective
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
油
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety速 services.Strategies for Effective Bioburden and Aseptic Control
Strategies for Effective Bioburden and Aseptic ControlMilliporeSigma
油
For an unparalleled experience throughout the life cycle of your therapy, BioReliance速 world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. MilliporeSigmas complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.Prof. Zhao Yarong, General Manager of Animal Medicine Research Center of Da B...
Prof. Zhao Yarong, General Manager of Animal Medicine Research Center of Da B...Kisaco Research
油
The document summarizes Dr. Zhao Yarong and the DBN Animal Medicine Research Center. It provides details about Dr. Zhao's background and accomplishments in vaccine research and development. It also provides an overview of DBN Group, the parent company of DBN Animal Medicine Research Center, including its size, areas of business, and facilities for vaccine research. Key resources and platforms at the research center that support vaccine R&D are highlighted.Biosafety & biosecurity lab biosecurity
Biosafety & biosecurity lab biosecurityAsif nawaz khan (AUST)
油
The Laboratory biosafety emphasizes the use of good microbiological practices, appropriate containment equipment, proper facility design, operation/maintenance and administrative considerations to minimize the risk of worker injury or illness.
ResumeHallidayLinkedInMar2016
ResumeHallidayLinkedInMar2016hallidayross
油
Ross Halliday has over 30 years of experience as an entomologist, with expertise in pest control, research, and education. He has owned his own pest control business, worked as an entomologist for various companies, published over 30 papers, and taught college courses. Currently he works as a technician for Willard's Pest Control providing residential and commercial pest control services.Quality for Biologics
Quality for BiologicsReportLinker.com
油
Quality for Biologics ' New ReportCritical quality attributes, process and change control, product variation, characterisation, and regulatory concernsSales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules ' they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.This unique 300 page report can help you to understand the processes involved ' knowledge that can save time and money and even make the difference between success and failure. The report covers all aspects of the subject including' Critical quality attributes ' Manufacturing process parameters' Process analytical technology' Physicochemical analysis,' Bioassays, ' Formulation and specifications' Product- and process-related impurities' Aggregation ' Non-clinical testing' Clinical development, ' Post-marketing period' Regulatory authority expectations' Risk management ' Comparability concernsQuality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:UCBUCB-CelltechEli LillyAmgenRocheParexel ConsultingGenentechStrategies for Effective Bioburden and Aseptic Control
Strategies for Effective Bioburden and Aseptic ControlMerck Life Sciences
油
For an unparalleled experience throughout the life cycle of your therapy, BioReliance速 world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Mercks complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.Bharat biotech company Overview 
Bharat biotech company Overview jenniferclark545
油
Bharat Biotechs research stems from the need to innovate and the necessity to address public health requirements of the developing nations, while adhering to IPR. Our business model is to support the advancement of technologies through strong collaborative research, and simultaneously support the establishment of strong innovative technology platforms for intellectual property reputed driven enterprise R&D.BRM Training Manual
BRM Training ManualAshfaq Ahmad
油
This training manual provides guidance on biorisk management for laboratory workers, field personnel, and research students working in veterinary laboratories in Pakistan. Biorisk management is important to control safety and security risks associated with handling biological materials and prevent unintentional exposure and accidental release. The manual covers terminology related to biorisk management, the scope and importance of establishing biorisk management systems in facilities, and the objectives of providing biorisk management training to raise awareness of biosafety and biosecurity practices.Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
油
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturingSMi Group's Superbugs and Superdrugs USA 2018
SMi Group's Superbugs and Superdrugs USA 2018Dale Butler
油
This document provides information on the 3rd annual Superbugs & Superdrugs USA conference taking place November 12-13, 2018 in Iselin, New Jersey. Anthony Simon Lynch and William Weiss will chair the event. Featured speakers will discuss topics such as pathogen-focused drug development, antibiotic resistance, novel modes of action to overcome resistance, and new anti-fungal developments. Participants will learn about funding opportunities, rapid diagnostic methods, and case studies. Two half-day workshops on November 14 will focus on rapid diagnostics for drug resistance and challenges of commercializing new antibiotics. SCYNEXIS, Inc. is sponsoring the conference.Introduction - OECD Seminar on Bioinformatics and Regulation of Microbial Pes...
Introduction - OECD Seminar on Bioinformatics and Regulation of Microbial Pes...OECD Environment
油
24 June 2019: This OECD seminar presented and discussed the potential use of genome sequence, bioinformatic tools and databases in a regulatory decision process for microbial pesticides.MJB CV Abbrv. V6 030916
MJB CV Abbrv. V6 030916Mike Buckley
油
Michael Buckley has over 25 years of experience in biotech developing monoclonal antibodies and antibody drug conjugates for oncology and immunology indications. He has held leadership roles at multiple biotech companies, directing preclinical and clinical development programs. Currently, he works as an independent consultant focusing on preclinical development and manufacturing of biologics from Phase I through commercial stage.SMi Group's Pharmaceutical Microbiology 2019
SMi Group's Pharmaceutical Microbiology 2019Dale Butler
油
This document provides information about the Pharmaceutical Microbiology UK conference, including workshops, being held January 21-23, 2019 in London. The two half-day post-conference workshops on January 23rd will focus on 1) setting up an effective environmental monitoring program and 2) developing a risk-based cleaning and disinfection program using rapid microbial methods. The conference will address current challenges and strategies in contamination control, regulations and trends for plasma-derived materials, environmental monitoring, and rapid microbial methods and alternative testing. It includes the agenda with over 20 speakers from leading pharmaceutical companies discussing case studies and best practices.BPK Resume - Q2 2016_3
BPK Resume - Q2 2016_3Brendan Keough
油
This document is a resume for Brendan Keough, who has 14 years of experience in biotechnology including roles in genomics, protein purification, and next generation sequencing. Currently he is a Manager at Lucigen Corporation where he oversees their NGS services business unit, generating sales leads, managing projects, and designing new services. Previously he held research roles at ioGenetics, eMetagen Corporation, and has authored several publications. He holds an M.Sc. in Biology and B.Sc. in Biochemistry and Molecular Biology.Article: On the Cusp of Curing Disease
Article: On the Cusp of Curing DiseaseMilliporeSigma
油
Welcome to the M Lab Collaboration Centers where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlabCompetency of natural product chemist
Competency of natural product chemistKhoirul Ngibad
油
This document outlines the competencies required of a natural product chemist. The chemist should have strong experience in bioassay directed drug discovery from natural sources like plants, functional foods, and cosmetics. They must be proficient in extracting, purifying, identifying, and quantifying bioactive compounds from natural products. In addition, the chemist should be experienced in developing processes for pilot production and scaling up leads into clinical development and commercialization. Strong knowledge of natural product biosynthesis, instrumentation like HPLC and NMR, and data analysis software is also required.Industry
Industrytkhurshid
油
Industry is comprised of large multinational companies and small to medium sized companies. Medical device products are generally developed through engineering disciplines to replace body functions, while pharmaceutical products are developed through complex scientific processes and tested in clinical trials based on quality, safety, and efficacy. Regulation of medical devices in Canada takes a risk-based, pre-market approval approach for individual products, while pharmaceuticals regulation is more prescriptive and varies according to product type within Health Canada.Fordyce Forum 2010 Final Photo & 際際滷 Review
Fordyce Forum 2010 Final Photo & 際際滷 ReviewJeff Skrentny
油
Final review of Fordyce Forum 2010 in Las Vegas from June in photos and slides from Jeff Skrentny, CERS, Conference Chair.iMarine achievements: three years and beyond, D. Castelli, CNR-ISTI & iMarine...
iMarine achievements: three years and beyond, D. Castelli, CNR-ISTI & iMarine...iMarine283644
油
The document summarizes the achievements and objectives of iMarine, an initiative to establish a data infrastructure to support ecosystem-based fisheries and marine resource management. It discusses iMarine's components, including an expert community and e-infrastructure. It also outlines iMarine's goals of facilitating data sharing, providing access to processed data and models, and supporting businesses. Finally, it discusses iMarine's role in building an ecosystem around marine data management and its potential to support other policy frameworks like Blue Growth.CDS and Loss function: CDO Tranches
CDS and Loss function: CDO TranchesBank Industry
油
This document discusses advanced tools for risk management and asset pricing. It contains an assignment analyzing credit default swap (CDS) term structures for three companies - Danone, Carrefour and Tesco. The assignment involves:
1) Deriving hazard rate term structures from CDS data assuming piecewise constant and constant default intensities. Constant intensities overestimate short-term but underestimate long-term default probabilities.
2) Performing sensitivity analysis on how hazard rates change with default frequency, recovery rates, and maturity. Higher frequencies and recovery rates increase hazard rates.
3) Calculating cumulative default probabilities from hazard rates.
4) Deriving portfolio loss distributions under a Gaussian copula model for different correlation parameters.HIPS Filament - Filaments.ca
HIPS Filament - Filaments.ca3d printing filament materials - Filaments.ca
油
Our 3D Printing dissolvable HIPS Filament is made from premium grade High Impact Polystyrene (HIPS) . It is is fully degradable and easily dissolved in Limonene.http://goo.gl/8y1r1CMore Related Content
What's hot (18)
Viral Risk Mitigation - A Global Regulatory Perspective
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
油
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety速 services.Strategies for Effective Bioburden and Aseptic Control
Strategies for Effective Bioburden and Aseptic ControlMilliporeSigma
油
For an unparalleled experience throughout the life cycle of your therapy, BioReliance速 world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. MilliporeSigmas complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.Prof. Zhao Yarong, General Manager of Animal Medicine Research Center of Da B...
Prof. Zhao Yarong, General Manager of Animal Medicine Research Center of Da B...Kisaco Research
油
The document summarizes Dr. Zhao Yarong and the DBN Animal Medicine Research Center. It provides details about Dr. Zhao's background and accomplishments in vaccine research and development. It also provides an overview of DBN Group, the parent company of DBN Animal Medicine Research Center, including its size, areas of business, and facilities for vaccine research. Key resources and platforms at the research center that support vaccine R&D are highlighted.Biosafety & biosecurity lab biosecurity
Biosafety & biosecurity lab biosecurityAsif nawaz khan (AUST)
油
The Laboratory biosafety emphasizes the use of good microbiological practices, appropriate containment equipment, proper facility design, operation/maintenance and administrative considerations to minimize the risk of worker injury or illness.
ResumeHallidayLinkedInMar2016
ResumeHallidayLinkedInMar2016hallidayross
油
Ross Halliday has over 30 years of experience as an entomologist, with expertise in pest control, research, and education. He has owned his own pest control business, worked as an entomologist for various companies, published over 30 papers, and taught college courses. Currently he works as a technician for Willard's Pest Control providing residential and commercial pest control services.Quality for Biologics
Quality for BiologicsReportLinker.com
油
Quality for Biologics ' New ReportCritical quality attributes, process and change control, product variation, characterisation, and regulatory concernsSales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules ' they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.This unique 300 page report can help you to understand the processes involved ' knowledge that can save time and money and even make the difference between success and failure. The report covers all aspects of the subject including' Critical quality attributes ' Manufacturing process parameters' Process analytical technology' Physicochemical analysis,' Bioassays, ' Formulation and specifications' Product- and process-related impurities' Aggregation ' Non-clinical testing' Clinical development, ' Post-marketing period' Regulatory authority expectations' Risk management ' Comparability concernsQuality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:UCBUCB-CelltechEli LillyAmgenRocheParexel ConsultingGenentechStrategies for Effective Bioburden and Aseptic Control
Strategies for Effective Bioburden and Aseptic ControlMerck Life Sciences
油
For an unparalleled experience throughout the life cycle of your therapy, BioReliance速 world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Mercks complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.Bharat biotech company Overview
Bharat biotech company Overview jenniferclark545
油
Bharat Biotechs research stems from the need to innovate and the necessity to address public health requirements of the developing nations, while adhering to IPR. Our business model is to support the advancement of technologies through strong collaborative research, and simultaneously support the establishment of strong innovative technology platforms for intellectual property reputed driven enterprise R&D.BRM Training Manual
BRM Training ManualAshfaq Ahmad
油
This training manual provides guidance on biorisk management for laboratory workers, field personnel, and research students working in veterinary laboratories in Pakistan. Biorisk management is important to control safety and security risks associated with handling biological materials and prevent unintentional exposure and accidental release. The manual covers terminology related to biorisk management, the scope and importance of establishing biorisk management systems in facilities, and the objectives of providing biorisk management training to raise awareness of biosafety and biosecurity practices.Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
油
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturingSMi Group's Superbugs and Superdrugs USA 2018
SMi Group's Superbugs and Superdrugs USA 2018Dale Butler
油
This document provides information on the 3rd annual Superbugs & Superdrugs USA conference taking place November 12-13, 2018 in Iselin, New Jersey. Anthony Simon Lynch and William Weiss will chair the event. Featured speakers will discuss topics such as pathogen-focused drug development, antibiotic resistance, novel modes of action to overcome resistance, and new anti-fungal developments. Participants will learn about funding opportunities, rapid diagnostic methods, and case studies. Two half-day workshops on November 14 will focus on rapid diagnostics for drug resistance and challenges of commercializing new antibiotics. SCYNEXIS, Inc. is sponsoring the conference.Introduction - OECD Seminar on Bioinformatics and Regulation of Microbial Pes...
Introduction - OECD Seminar on Bioinformatics and Regulation of Microbial Pes...OECD Environment
油
24 June 2019: This OECD seminar presented and discussed the potential use of genome sequence, bioinformatic tools and databases in a regulatory decision process for microbial pesticides.MJB CV Abbrv. V6 030916
MJB CV Abbrv. V6 030916Mike Buckley
油
Michael Buckley has over 25 years of experience in biotech developing monoclonal antibodies and antibody drug conjugates for oncology and immunology indications. He has held leadership roles at multiple biotech companies, directing preclinical and clinical development programs. Currently, he works as an independent consultant focusing on preclinical development and manufacturing of biologics from Phase I through commercial stage.SMi Group's Pharmaceutical Microbiology 2019
SMi Group's Pharmaceutical Microbiology 2019Dale Butler
油
This document provides information about the Pharmaceutical Microbiology UK conference, including workshops, being held January 21-23, 2019 in London. The two half-day post-conference workshops on January 23rd will focus on 1) setting up an effective environmental monitoring program and 2) developing a risk-based cleaning and disinfection program using rapid microbial methods. The conference will address current challenges and strategies in contamination control, regulations and trends for plasma-derived materials, environmental monitoring, and rapid microbial methods and alternative testing. It includes the agenda with over 20 speakers from leading pharmaceutical companies discussing case studies and best practices.BPK Resume - Q2 2016_3
BPK Resume - Q2 2016_3Brendan Keough
油
This document is a resume for Brendan Keough, who has 14 years of experience in biotechnology including roles in genomics, protein purification, and next generation sequencing. Currently he is a Manager at Lucigen Corporation where he oversees their NGS services business unit, generating sales leads, managing projects, and designing new services. Previously he held research roles at ioGenetics, eMetagen Corporation, and has authored several publications. He holds an M.Sc. in Biology and B.Sc. in Biochemistry and Molecular Biology.Article: On the Cusp of Curing Disease
Article: On the Cusp of Curing DiseaseMilliporeSigma
油
Welcome to the M Lab Collaboration Centers where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlabCompetency of natural product chemist
Competency of natural product chemistKhoirul Ngibad
油
This document outlines the competencies required of a natural product chemist. The chemist should have strong experience in bioassay directed drug discovery from natural sources like plants, functional foods, and cosmetics. They must be proficient in extracting, purifying, identifying, and quantifying bioactive compounds from natural products. In addition, the chemist should be experienced in developing processes for pilot production and scaling up leads into clinical development and commercialization. Strong knowledge of natural product biosynthesis, instrumentation like HPLC and NMR, and data analysis software is also required.Industry
Industrytkhurshid
油
Industry is comprised of large multinational companies and small to medium sized companies. Medical device products are generally developed through engineering disciplines to replace body functions, while pharmaceutical products are developed through complex scientific processes and tested in clinical trials based on quality, safety, and efficacy. Regulation of medical devices in Canada takes a risk-based, pre-market approval approach for individual products, while pharmaceuticals regulation is more prescriptive and varies according to product type within Health Canada.Viewers also liked (17)
Fordyce Forum 2010 Final Photo & 際際滷 Review
Fordyce Forum 2010 Final Photo & 際際滷 ReviewJeff Skrentny
油
Final review of Fordyce Forum 2010 in Las Vegas from June in photos and slides from Jeff Skrentny, CERS, Conference Chair.iMarine achievements: three years and beyond, D. Castelli, CNR-ISTI & iMarine...
iMarine achievements: three years and beyond, D. Castelli, CNR-ISTI & iMarine...iMarine283644
油
The document summarizes the achievements and objectives of iMarine, an initiative to establish a data infrastructure to support ecosystem-based fisheries and marine resource management. It discusses iMarine's components, including an expert community and e-infrastructure. It also outlines iMarine's goals of facilitating data sharing, providing access to processed data and models, and supporting businesses. Finally, it discusses iMarine's role in building an ecosystem around marine data management and its potential to support other policy frameworks like Blue Growth.CDS and Loss function: CDO Tranches
CDS and Loss function: CDO TranchesBank Industry
油
This document discusses advanced tools for risk management and asset pricing. It contains an assignment analyzing credit default swap (CDS) term structures for three companies - Danone, Carrefour and Tesco. The assignment involves:
1) Deriving hazard rate term structures from CDS data assuming piecewise constant and constant default intensities. Constant intensities overestimate short-term but underestimate long-term default probabilities.
2) Performing sensitivity analysis on how hazard rates change with default frequency, recovery rates, and maturity. Higher frequencies and recovery rates increase hazard rates.
3) Calculating cumulative default probabilities from hazard rates.
4) Deriving portfolio loss distributions under a Gaussian copula model for different correlation parameters.HIPS Filament - Filaments.ca
HIPS Filament - Filaments.ca3d printing filament materials - Filaments.ca
油
Our 3D Printing dissolvable HIPS Filament is made from premium grade High Impact Polystyrene (HIPS) . It is is fully degradable and easily dissolved in Limonene.http://goo.gl/8y1r1CPost-market RMP/ASA updates
Post-market RMP/ASA updatesTGA Australia
油
This document provides guidance on when updated Risk Management Plans (RMPs) should be submitted to the Therapeutic Goods Administration (TGA) for approved drugs in Australia and New Zealand. Updated RMPs should be submitted if there are significant changes to the risk-benefit analysis, new safety concerns, or changes to pharmacovigilance or risk minimization activities. Minor routine updates and changes unrelated to safety do not require RMP updates. Updated RMPs should follow the required format and include a summary of changes from the previous version. The TGA will acknowledge receipt and may request clarification or discussion if needed. Contact information is provided for questions.How The Unconnected Employee Hurts Your Business
How The Unconnected Employee Hurts Your BusinessContacts Count
油
Employees who do not reach out and connect with others, within your unit and outside of it, can really hurt your business. See how it hurts - and what you can do to begin to turn it around.Pbnm 2.0 nacc sme beta
Pbnm 2.0 nacc sme betaLiasion Office Lagos
油
The document discusses Private Business Network Marketplace (PBNM), a virtual business ecosystem platform that allows organizations to build new markets, products, services, and manage resources better through various virtual expo solutions. The PBNM platform offers strategic partners and clients opportunities for both real-life and online collaborative engagement. It provides tools for customer nurturing, personalized exhibit booths, automated follow-up systems, and helps boost sales. The platform aims to create a sustainable competitive advantage for organizations by connecting stakeholders within a collaborative virtual network.The Crusades
The Crusadesmilesm
油
The document provides steps to sketch the path of a rock launched from a catapult based on given parameters. It determines the cosine equation f(x) = -90 cos(x/50) + 90 that models the rock's maximum height of 180m and range of 100m, and the equivalent sine equation f(x) = 90 sin(x/50 - 22.5) + 90.LG+A290
LG+A290vivekyadav128254
油
The document provides information about the LG A290 mobile phone. It lists the LG A290 price from multiple retailers ranging from Rs. 3,333 to Rs. 4,100. It also includes specifications of the LG A290 such as its display size of 2.2 inches, 1.3 MP camera, Bluetooth connectivity, and 1500 mAh battery. Images and a review of the LG A290 are available on the website as well as a comparison to similar mobile phones.David Meyer, PhD Welcome Remarks & Introduction to LA BioMed
David Meyer, PhD Welcome Remarks & Introduction to LA BioMedUCLA CTSI
油
David Meyer, PhD Welcome Remarks & Introduction to LA BioMed
President/CEO, Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center
Stadtkolloquium workshop presentation - March 2013 - UCL - London
Stadtkolloquium workshop presentation - March 2013 - UCL - LondonElnaz Ghafoorikoohsar
油
This document outlines a research study exploring how urban planning practices affect encounters in diverse public spaces. The study aims to examine how planning impacts convivial encounters between different ethnic groups in retail marketplaces. It will conceptualize a typology of convivial encounters and identify the effects of planning on encounters. An ethnographic study involving observation and interviews in selected marketplaces will explore the role of encounters in improving intercultural understanding or entrenching differences. The research seeks to establish encounter as a social logic for diversity-focused planning and provide recommendations.Technical Trainer Assessors Jobs Ref 1504-29
Technical Trainer Assessors Jobs Ref 1504-29Sean Durrant
油
This job posting is for a Technical Trainer Assessor position in the South East of England. The role involves maintaining staff competence through training, delivering training programs, conducting assessments, and documenting training materials. A background in rolling stock maintenance or heavy engineering is required, along with relevant qualifications. The position pays 贈35,000-贈38,000 annually with benefits. The posting is from Clements Technical Recruitment, a recruiting agency that specializes in engineering and technical roles.Handling Uncertainty under Spatial Feature Extraction through Probabilistic S...
Handling Uncertainty under Spatial Feature Extraction through Probabilistic S...International Journal of Science and Research (IJSR)
油
The Extraction of Spatial Features from remotely sensed data and the use of this information as input into further decision making systems such as geographical information systems (GIS) has received considerable attention over the few decades. The successful use of GIS as a decision support tool can only be achieved, if it becomes possible to attach a quality label to the output of each spatial analysis operation. Thus the accuracy of Spatial Feature Extraction gained more attention as geographic features can hardly formulated in a certain pattern due to intra-class variation and inter-class similarity. Besides these Spatial Feature Extraction further include positional uncertainty, attribute uncertainty, topological uncertainty, inaccuracy, imprecision/inexactitude, inconsistency, incompleteness, repetition, vagueness, noisy, omittance, misinterpretation, misclassification, abnormalities and knowledge uncertainty. To control and reduce uncertainty in an acceptable degree, a Probabilistic shape model is described for Extracting Spatial Features from multi-spectral image. The advantages of this, as opposed to the conventional approaches, are greater accuracy and efficiency, and the results are in a more desirable form for most purposes.
Assessment 1
Assessment 1Bryan Abos-Padilla Velasquez
油
This document discusses qualities of language testing according to several authors. It examines reliability, validity, authenticity, interactiveness, impact, and washback. Reliability refers to consistency of test results, and can be affected by factors like test design, administration, and scoring. Validity means the test accurately measures what it intends to, including content, face, and construct validity. Authenticity and interactiveness relate to how engaged test-takers feel with real-world tasks. Impact refers to effects on test-takers and the educational system. Washback describes effects of testing on teaching and learning, which can be positive like clarifying expectations, or negative like overly test-driven curricula.Aboutme1
Aboutme1eduatecu
油
Lymiah Bibi is a third year student at Edith Cowan University studying for a Bachelor's Degree in Early Childhood studies. She enjoys nature, visiting places of interest, and being around animals. She has a passion for children and chose this profession to be involved in their education. While in Australia, she is gaining new learning opportunities at ECU. Teaching and learning with computers presents challenges but also opportunities. Computers have always fascinated her as an Early Childhood teacher but she had limited opportunities until now to develop skills, which she hopes to apply in her teaching. She expects the CPE4112 course to equip her with further knowledge and skills to integrate computer technology appropriately in her early years teaching.Pp gr 9 reg 2013
Pp gr 9 reg 2013Lorie Perrault
油
This document provides information for grade 9 students and parents about pre-registration for grade 10 at Tisdale Middle Secondary School. It outlines the school's semester schedule, assessment periods, daily bell schedule, and programs offered. Requirements for grades 10-12 are presented for core subjects like English, math, science, and electives. Course selection forms are included for students to choose their classes. Extracurricular clubs and activities are also listed.Enduring Cultures
Enduring Culturesveb2k5
油
What Is Culture? The Difference Between Culture with big C and little c, Ancient Cultures That Have Endured.Handling Uncertainty under Spatial Feature Extraction through Probabilistic S...
Handling Uncertainty under Spatial Feature Extraction through Probabilistic S...International Journal of Science and Research (IJSR)
油
Similar to ABALL_PDA (20)
ABALL_ASM
ABALL_ASMAnthony Ball
油
Toxikon will be exhibiting at the 114th General Meeting for the American Society for Microbiology from May 18-20 in Boston. Their study director Anthony Ball will be participating in a mentoring breakfast on May 20th, where he will mentor on careers in industry. Toxikon provides microbiology services such as sterility testing, bioburden determination, and endotoxin evaluation to support product development and registration.PEGS Boston the essential protein engineering summit
PEGS Boston the essential protein engineering summitNicole Proulx
油
With record-breaking attendance in 2015, PEGS Boston attracts an international delegation of nearly 2,000 participants including conference delegates, speakers, exhibitors, sponsors and guests representing over 30 countries.
Participants value the in-depth short courses, access to 22 conferences, and wide-ranging presentations delivering new unpublished data, case studies, innovation and insight.
The vast exhibit hall will be packed with 125 exhibiting companies and more than 200 research posters on display providing valuable viewing of innovative new technologies, as well as abundant networking with biopharma researchers and industry representatives.Immunobiology and new challenges in drug development
Immunobiology and new challenges in drug developmentDr Kurt Sales
油
This document provides an agenda and background information for an immunobiology day event hosted by Charles River Laboratories. The event will cover regulatory frameworks for developing biological therapeutics, suitable animal species for testing, bioanalysis techniques, immunophenotyping assays, and challenges of pharmacokinetics for large molecules. Speakers will discuss regulatory guidelines, validating cell-based assays, analyzing macromolecules, using nonhuman primates in safety testing, and strategies for drug metabolism and pharmacokinetics research on large molecules. Attendees will learn about typical development programs and challenges in preclinical testing of biotherapeutics.MRADUS16-PBCUS16_Agenda
MRADUS16-PBCUS16_AgendaKatarina Kadovic
油
The document provides information about the 4th Microbiome R&D and Business Collaboration Forum and Probiotics Congress that will take place from 3-4 October 2016 in La Jolla, San Diego. The conference will explore research on the human microbiome and its role in health and disease, as well as commercial opportunities. Over 250 attendees are expected, including leading academics and industry experts who will give presentations on topics like gut and skin microbiota, probiotics, and commercializing microbiome research. The schedule provides details on speakers, session topics, sponsors, and arrangements.pharmaceutical application of microbial technology.pptx
pharmaceutical application of microbial technology.pptxberciyalgolda1
油
This document discusses key aspects of pharmaceutical microbiology. It begins by defining pharmaceutical microbiology as the study of microorganisms related to production of pharmaceutical products like antibiotics, enzymes and vaccines. It then describes several factors involved in pharmaceutical microbiology like microbial contamination, limits testing, antimicrobial preservation and sterilization techniques. The document emphasizes the importance of controlling microbes during drug manufacturing and storage to ensure product safety and quality.2011 October - PCT News Discovery Starts With Sample Preparation
2011 October - PCT News Discovery Starts With Sample PreparationPressure BioSciences, Inc.
油
This document discusses presentations made by independent researchers at scientific conferences highlighting the advantages of Pressure Cycling Technology (PCT) developed by Pressure BioSciences, Inc. It notes that PCT allows faster and improved sample processing for applications such as biomarker discovery. Pressure BioSciences believes increased awareness and acceptance of PCT will lead to increased revenue in the second half of 2011 compared to the first half. The company is working to commercialize new PCT-based instruments and raise capital to support sales and marketing efforts.Sherrie-BainCV-2016
Sherrie-BainCV-2016Sherrie Bain
油
This document contains Sherrie Bain's resume. She is seeking a position that allows her to utilize her expertise in microbiology and education. She has over 20 years of experience in these fields, including roles as a researcher, instructor, consultant, and more. Her skills include molecular genetics, laboratory management, project management, and environmental assessment. She holds advanced degrees in microbiology and has published research articles.Pharmaceutical microbiology 
Pharmaceutical microbiology VennelaNampalli1
油
Microbiology is the study of microorganisms like bacteria, fungi, and protozoa. Pharmaceutical microbiology applies microbiology to the production of medicines, focusing on microbes involved in antibiotics, vaccines, and other drugs. It ensures product safety through testing, limits on contamination, and sterilization. Proper controls are vital for pharmaceutical quality and preventing infectious disease.Company Profile
Company ProfileInovio Pharmaceuticals, Inc.
油
The document summarizes recent advances at Inovio Pharmaceuticals, including being selected as a top translational researcher, generating immune responses in head and neck cancer patients, and protecting animals from Zika infection. It then discusses Inovio's plans to initiate a phase III trial for its HPV immunotherapy in 1H17 after an FDA request for additional information, and its partnership with MedImmune to develop immuno-oncology combination therapies. The document provides an overview of Inovio's immunotherapy technology platform and its potential applications in infectious diseases and cancer.Ti棚u chu畉n ph嘆ng s畉ch trong s畉n xu畉t vaccine 
Ti棚u chu畉n ph嘆ng s畉ch trong s畉n xu畉t vaccine C担ng ty C畛 ph畉n T動 v畉n Thi畉t k畉 GMP EU
油
Ti棚u chu畉n ph嘆ng s畉ch trong s畉n xu畉t vaccine . Xem th棚m c叩c ti li畛u kh叩c tr棚n k棚nh c畛a C担ng ty C畛 ph畉n T動 v畉n Thi畉t k畉 GMP EUPEGS China 2015 Final Agenda
PEGS China 2015 Final AgendaNicole Proulx
油
This 3-day event is the meeting place for international and domestic scientists to share case studies and project updates, showcase new techniques and form collaborations that pave the way towards the future of Chinas biopharmaceutical industry.Bridging The Valley Of Death A Tale Of Two Cultures
Bridging The Valley Of Death A Tale Of Two Culturesrwmalonemd
油
This document discusses the challenges of transitioning biotechnology discoveries from research to commercial products, known as crossing the "valley of death". It notes that on average only 1 in 4 to 1 in 5 biotechnology products in development achieve approval due to fundamental differences between the cultures of research and product development. Bridging this gap requires addressing regulatory, capital, and project management challenges throughout the product development process. The future of biotechnology will rely on rigorous project planning, outsourcing, earlier consideration of development pathways, and continual engagement between research and development teams.India's first Int'l Conference on Best Practices in Pharma Microbiology 
India's first Int'l Conference on Best Practices in Pharma Microbiology Biocon
油
This is the first time that Pharmig, an international Pharmaceutical Microbiology think tank based out of the UK is organizing a conference on the "Best Practices in Pharma Microbiology" for the first time in India. You can register
by sending an email to maxine@pharmig.org.uk. For booking a seat for the conference, please visit: http://bit.ly/1J4gtLhPEGS Europe Protein & Antibody Engineering Summit 2014 Agenda
PEGS Europe Protein & Antibody Engineering Summit 2014 AgendaNicole Proulx
油
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this years event will feature:
500 attendees
150 technical presentations
70+ scientific posters
40+ sponsors & exhibitors
Dedicated networking opportunities
Exclusive exhibit & poster hours
Interactive roundtable, breakout & panel discussions
PEGS China-2016-Brochure
PEGS China-2016-BrochureNicole Proulx
油
In its third year, PEGS China: Protein and Antibody Engineering & Development Summit returns to Shanghai for 3 days of inspiring presentations and case studies featuring the latest trends and future potential of Chinas biotech industry.
This years event comprises four content-driven conferences with over sixty global speakers, plus a new 1-day seminar on clinical & regulatory strategies for global and domestic IND and BLA filings. In addition, dedicated exhibit hall and poster viewing hours will provide invaluable opportunities for networking, deal-making and ideas exchange.
Biosafety-Guidelines & Levels basics.pptx
Biosafety-Guidelines & Levels basics.pptxHimalini1
油
you can know about the basic information about the biosafety levels and guidelinessBiosimilars global congress 2014 europe copy 3 (6)
Biosimilars global congress 2014 europe copy 3 (6)chetanpatel73
油
Biosimilars Global Congress 17-19 September 2014 Hilton Kensington London. email chetan.patel@paradigmglobalevents.com for early bird prices.Vaccine101, Dynport Vaccine Company LLC
Vaccine101, Dynport Vaccine Company LLCJohns Hopkins Institute for NanoBioTechnology
油
This document provides a high-level overview of the vaccine development process from research and testing in animals through clinical trials in humans and regulatory approval. It discusses key stages including preclinical research in animal models to test safety and efficacy, phases of human clinical trials, requirements for good manufacturing practices and regulatory compliance, and the role of quality assurance. It also provides examples of DVC's experience developing vaccines for biodefense threats like anthrax, smallpox, and plague.SMi Group's Superbugs and Superdrugs USA 2016
SMi Group's Superbugs and Superdrugs USA 2016Dale Butler
油
This document provides information about the "Superbugs & Superdrugs USA" conference happening from November 14-16, 2016. It advertises the opportunity to register for the conference at discounted rates by certain deadlines. The conference will focus on developing new drugs to combat antibiotic resistance and will feature expert speakers from organizations like the WHO, BARDA, NIH, Pfizer and others. An interactive workshop on animal models in pre-clinical drug development will also be held.Microbion_nutraceuticals_emailing
Microbion_nutraceuticals_emailingAntonio Del Casale
油
Microbion offers analytical, research and development, and bio-bank services for nutraceutical companies. Their services include genomic analysis of microorganisms used in probiotics and fermented foods, as well as assessing genetic stability, purity, safety, and validating health claims. Microbion can also authenticate strains using DNA fingerprinting and develop diagnostic methods and protocols tailored for specific customer strains or formulations.ABALL_PDA
- 1. Contact | Sitemap Search: 800.458.4141 NEWS & EVENTS INDUSTRY EVENTS AND TRADE SHOWS PREVIOUS EVENTS AND TRADESHOWS NEWS & EVENTS Toxikon's Poster Presentation at the PDA/FDA Virus & TSE Safety Conference Anthony R. Ball, a Study Director in the Department of Microbiology, was among a handful of scientists presenting a poster at the 2014 PDA/FDA Virus & TSE Safety Conference this past week in Bethesda, Maryland. This conference brought together regulatory experts and industry professionals for a review of current thinking in the area of product safety as it relates to Viruses and Transmissible Spongiform Encephalopathy (TSE) agents. The program covered emerging virus detection methods, considered virus safety risks associated with biological reagents used during expression cell cloning, the risk associated with new cell substrates as well as bioreactor contamination risks and risk mitigation measures. The program also covered robust virus clearance methods and strategic virus clearance considerations. Mr. Ball presented methodologies and their rational on the utilization of a bacteriophage model to simulate transmissible viral ingression into sterile fluid paths. To view his poster, A Simple Solution for Medical Device Viral Ingress Testing using Bacteriophage, please click here. About Toxikon's Presenter Anthony Ball is a Study Director for the Department of Microbiology at Toxikon Corporation. Mr. Ball manages microbiology studies leading to product registration. He develops new test procedures and associated validations and services. He also provides technical guidance for Toxikons Research Associates. Mr. Balls area of expertise includes antimicrobial drug discovery and validation of medical devices. Mr. Ball received his Biology degree from Northeastern University. His current position at Toxikon allows for the evaluation and development of promising and novel antimicrobial modalities. Mr. Ball also plays an active role as an AAMI member. About Toxikon's Microbiology Department The diverse capabilities within the Microbiology Department are leveraged appropriately to address each unique product requirement. With the emergence of complex devices, such as combination products, our team has become recognized by the industry as a valuable resource in developing early stage screening studies to product and validation studies. Toxikon's microbiology capabilities at a glance: Bioburden Endotoxin Testing Sterility Testing Reusable Device Studies Compendial Testing Antimicrobial Testing Want to learn more? Click here to contact us. ABOUT US QUALITY & REGULATORY SERVICES PARTNERS RESOURCES CAREERS NEWS & EVENTS Preclinical CRO | Global Contract Research Company | P... http://www.toxikon.com/news-events/index.cfm?id=Toxikon... 1 of 2 10/5/14 3:29 PM
- 2. Ingress Testing Browse our website for more information or contact us at 800.458.4141 or info@toxikon.com. All current news releases About Us | Quality & Regulatory | Services | Partners | Resources | Careers | News & Events | Contact | Sitemap | Legal | Site Credits 息2010 Toxikon, Inc. Preclinical CRO | Global Contract Research Company | P... http://www.toxikon.com/news-events/index.cfm?id=Toxikon... 2 of 2 10/5/14 3:29 PM