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PFQ and Food Quality Webcast Channel

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  • Capsules for Use in Dry Powder Inhalers (DPIs) in Early Phase Dev
    Capsules for Use in Dry Powder Inhalers (DPIs) in Early Phase Dev
    Matt Richardson, Capsugel; Massimo Moratto, Aptuit; Mike Savill, Capsugel Recorded: Jun 28 2011 69 mins
    Finding efficient drug delivery methods is becoming increasingly important as the pharmaceutical industry looks to improve the performance of its new compounds and extend the applications of existing drugs. One option that has long been used to successfully treat respiratory conditions and provide compounds with a fast-acting route into circulation is drug delivery via inhalation using a dry powder inhaler (DPI).

    Capsugel’s Xcelodose technology is ideally suited to meet the specialized demand for filling capsules for DPI use, as it is proven to dispense very low weights repeatably with precision and accuracy. The technology is suitable for any dry powder, including micronized and cohesive powders, and fills the powder into the capsule without compressing or compacting the powder base, thereby facilitating evacuation on inhalation. Collaborative data shows that the action of filling does not give rise to segregation of blended products provided the constituents have similar particle size and density, nor will it degrade the bonds between API and carrier particles.

    Matt Richardson, Pharmaceutical Business Development Manager, Capsugel
    Matt has a BS in Chemistry (Wofford College) and Ph.D. (Wake Forest) in synthetic organic and organometallic chemistry. Prior to joining Capsugel in 2005, he worked in process development and scale up of pharmaceuticals.

    Massimo Moratto, Senior Scientist Pharmaceutical Development, Aptuit
    Massimo has worked in formulation development at Aptuit, formerly GSK, for ten years. He works with solid oral dosage forms, Dry Powder Inhaler formulations and is responsible for upgrading the Aptuit Verona facility for respiratory technologies, including the purchase of a new Xcelodose 600S.

    Mike Savill, Pharmaceutical Technology Manager, Capsugel
    Mike supports product and process development for Capsugel’s laboratory equipment. He has helped develop the Xcelodose technology and specialises in the automated precision dosing of dry powders.
  • Identify and Manage Supplier Risk Like Never Before
    Identify and Manage Supplier Risk Like Never Before
    Gary Nowacki, TraceGains, and Jack Kennedy, Chelsea Milling Company Recorded: Jun 1 2011 75 mins
    Automating ingredient specification and supplier compliance helps minimize risk, improve quality, and accelerate profitability. Immediate feedback, coaching, and corrective action monitoring for suppliers is a win-win for both sides. Tune into our webinar to learn how to:

    • Lower your manufacturing costs, cost of poor quality, and charge-backs.
    • Receive instant notifications when suppliers' audits, insurance certifications, and any other compliance items are due to expire.
    • Link your own lab data to your suppliers' shipped lots and continuously compare results.
    • Easily manage GFSI (BRC, SQF, etc.) audit data collection.
    • Automatically generate corrective action reports to suppliers for any non-compliance.
    • Achieve continuous product improvement.

    Gary Nowacki, CEO of TraceGains, joined the company in January 2008 after holding a variety of software industry executive positions in ERP, Supply Chain Management, and Quality Solutions. Gary has 30 years experience designing and implementing advanced solutions for Food & Beverage, Nutraceuticals, and Consumer Packaged Goods (CPGs).

    “We designed TraceGains for Quality, Purchasing, and Sourcing managers who are dissatisfied with the high cost and high risk of manual tracking and control of ingredients and suppliers. TraceGains is a complete compliance and risk management solution that automates data from paper or electronic filing cabinets and makes it actionable," says Nowacki.

    Jack Kennedy is VP Operations, General Manager, and Director of Chelsea Milling Company, the makers of “Jiffy Mixes” brand baking mix and CMC Foods institutional and foodservice baking mixes. Jack has been a food industry manager since 1974, when he started his career with Welch Foods, Inc. After 12 years, he moved to Ocean Spray Cranberries, Inc. In 1995, he came to Chelsea Milling Company, where he is one of the first non-family members to hold an executive position in this over 100 year old family business.
  • Strategies for Producing Membrane Proteins in E. coli vs. Yeast
    Strategies for Producing Membrane Proteins in E. coli vs. Yeast
    Dr. James Love, New York Consortium on Membrane Protein Structure, and Mark Dumont, University of Rochester Medical Center Recorded: Mar 16 2011 76 mins
    How do you deal with commonly encountered problems and bottlenecks that occur when trying to express and purify membrane proteins (MPs) for structural biology? Current Protocols (www.currentprotocols.com) and The Protein Society (www.proteinsociety.org) are pleased to present a free 1-hour webinar by two leaders in MP production: James Love, Head of Research for the New York Consortium on Membrane Protein Structure, will speak on challenges and solutions for working with MPs in E. coli, and Mark Dumont from the will discuss the same topics for yeast systems. Plus, Drs. Love and Dumont will answer your questions live!

    - Advantages and disadvantages of yeast and E. coli expression systems
    - Rapid high-throughput cloning, expression and purification procedures
    - Vectors and tags
    - Maximizing expression levels
    - Cell lysis
    - Protein stability and minimizing proteolysis
    - Detergent selection

    James Love is Head of Research for The New York Consortium on Membrane Protein Structure (NYCOMPS), one of nine specialized centers focusing on MPs as part of the Protein Structure Initiative: Biology. Dr Love has published on high-throughput methodologies developed specifically for integral MPs, which have been used to process more than 5,000 membrane proteins. With this work, NYCOMPS has solved many exciting membrane protein structures.

    Mark Dumont is a Professor of Biochemistry and Biophysics at the University of Rochester Medical School. One of the Principal Investigators of the Membrane Protein Structural Biology Consortium, he has been involved in expression and purification of MPs as part of the Center for High Throughput Structural Biology, and the project for Structural Genomics of Pathogenic Protozoa. His work on MPs in yeast has spanned individual targets to genome-wide studies.

    Who Should Attend:
    Researchers who need to produce MPs for functional or structural studies (e.g., activity assays or crystallization).
  • Harnessing the Power of High-Res, Accurate Mass LC/MS Technology
    Harnessing the Power of High-Res, Accurate Mass LC/MS Technology
    Dipankar Ghosh, Ph.D., Tina Hemenway, Ph.D.,Thermo Fisher Scientific Recorded: Jan 25 2011 63 mins
    Harnessing the Power of High-Resolution, Accurate Mass LC/MS Technology in Food Safety Laboratories

    In this webinar, you will learn the advantages of high-resolution, accurate mass LC/MS technology and how it can be applied in the food safety laboratory. Instrumentation that offers high resolving power and ultimate mass accuracy provide unique advantages in screening and quantifying low levels of contaminants in complex food matrices. Software is the key to efficient processing of this data to obtain quantitative and qualitative results. Attend this webinar to learn what features to look for in a high-resolution solution for your lab:

    -- What do you need to streamline your workflow and increase throughput?
    -- How are results verified so you have a high level of confidence in your results?
    -- How can you screen for unknowns?
  • A Complete Manufacturing Approach to Water Activity Monitoring
    A Complete Manufacturing Approach to Water Activity Monitoring
    Brady Carter, Research Scientist, Decagon Devices Recorded: Jan 11 2011 75 mins
    A Complete Manufacturing Approach to Effective Water Activity Monitoring

    This seminar will provide information about strategies to control product consistency, quality and safety using water activity testing at key locations in a manufacturing facility. Strategies using water activity to facilitate product development and formulation in the R&D lab will be discussed. Applications for water activity in ensuring the quality and consistency of incoming ingredients at ingredient inspection also will be discussed. Information will be provided on ways for QA/QC departments to effectively use water activity as a release specification during production. Finally, strategies for determining shelf life and monitoring conditions while the product is stored in packaging and shipped to the consumer will be provided.

    Major Learning Objectives:

    1) Critical quality and safety factors that can be controlled by water activity

    2) How water activity can replace your moisture content specification

    3) Effective use of water activity:

    - in the R&D lab

    - for ingredient inspection

    - by QA/QC as a release specification

    - in storage and transport

    Brady Carter, MS is a Research Scientist at Decagon Devices, Inc. Before joining Decagon, he was an Assistant Research Scientist at Washington State University. Mr. Carter received his bachelor degree in Botany from Weber State University in 1997 and his master’s degree in Cereal Chemistry from Washington State University in 1999.
  • Innovation in Tablet Color Coating Systems
    Innovation in Tablet Color Coating Systems
    Phillip Butler Recorded: Oct 28 2010 58 mins
    In this webinar you will learn how to:

    •Create your own film-coating colors
    •Improve production efficiencies
    •Increase process robustness
    •Reduce process complexity

    with Kollicoat® IR Coating Systems – easy to disperse complete coating systems with excellent handling properties.

    Webinar speaker:

    Philip Butler
    Technical Sales Manager for Coatings in North America
    Pharma Ingredients and Services, Care Chemicals Division
    BASF Corporation, United States

    Registration open until October 4th, 2010.
  • From Screening to Confirmation: Integrated POPs Analysis Workflow
    From Screening to Confirmation: Integrated POPs Analysis Workflow
    Dirk Krumwiede, Hans-Joachim Huebschmann Recorded: Oct 6 2010 84 mins
    This webinar focuses on the workflow for the analysis of Persistent Organic Pollutants (POPs) with the determination of dioxin/furans in food samples. A new concept for the combined and integrated use of screening and confirmation methods will be presented. The application of dedicated highly selective mass spectrometry technologies for the analysis of dioxins and furans in milk samples will be discussed using real-life data.

    What you will learn:

    - What is POPs screening? What is confirmation? How do the analytical requirements differ for these tasks?
    - Sample analysis workflow from fast screening to precise confirmation analysis.
    - Latest GC-MS/MS triple quadrupole mass spectrometry solution for optimum screening analysis.
    - Latest GC-HRMS magnetic sector mass spectrometry solution for optimum confirmation analysis.
    - Integrated data evaluation with a common software suite.
    - Approaches and investigations for an optimized sample preparation process.
    - Overall advantages of the integrated POPs analysis workflow.

    Who should attend:
    - Lab managers and Quality Assurance managers from food industry, contract and governmental laboratories.
    - Anybody interested in effective Dioxin/Furan analysis in food, feed environmental or biological samples.
  • Overcoming Practical Challenges of Pesticide Residue Analysis
    Overcoming Practical Challenges of Pesticide Residue Analysis
    Ken Rosnack, Waters Corporation Recorded: Sep 14 2010 64 mins
    Overcoming Practical Challenges of Pesticide Residue Analysis Through Integrated Technology and Workflow Solutions

    One of the biggest challenges in ensuring the safety of our food supplies is the measurement of hazardous, ultra trace level components in the presence of a highly complex sample matrix. For the analysis of pesticides in food matrices the increased use of liquid chromatography systems coupled with tandem quadrupole mass spectrometers has allowed progress in reducing the problems caused by the sample matrix. This talk will focus on an integrated workflow for multi-residue pesticide analysis in complex matrices. The ability to understand the matrix challenge of each injected sample is clearly beneficial, as is the ability to monitor changes in the sample matrix between samples and batches. Integrating an effective workflow can lead to the continuous improvement of productivity and analytical quality in the laboratory. Discussions will include method development / optimization by automating set up of the MS hardware (mass resolution, mass calibration, ion source optimization) as well as the process of developing compound-specific MRM data acquisition methods.

    Webinar Speaker:

    Ken Rosnack
    Business Development Manager
    World Wide Chemical Analysis Marketing Group
    Waters Corporation
  • Accelerating the Timeline to First-in-human Trials
    Accelerating the Timeline to First-in-human Trials
    David Edwards, Capsugel; Tim Scott, Pharmatek Laboratories; Joseph Forth, AMRI Recorded: Jul 13 2010 85 mins
    Accelerating the Timeline to First-in-human Trials: NEW Case Studies on API in Capsule Technology

    Accurately and precisely dispensing drug substances alone, in tiny amounts as low as 100 micrograms into capsules, excipients or bulking agents is changed the process of drug development.

    Today, Pharma companies use micro-dosing technology to shorten drug development by reducing the need for costly time-consuming stability and pre-formulation studies. Reducing the time it takes to reach the critical "first in human" clinical decision point allows an increase in throughput of candidate compounds for development, thereby enabling pharma development departments to focus their resources on potential winners.

    This webinar will feature NEW case studies on the Capsugel technology. Speakers include:

    David Edwards, Director of Pharmaceutical Technology, Capsugel
    Tim Scott, President, Pharmatek Laboratories
    Joseph Forth, Manager, Pharmaceutical Development AMRI
  • Food Safety Legislation and Regulation - Ready or Not?
    Food Safety Legislation and Regulation - Ready or Not?
    Ed Johnson, Esq. Regulatory Analyst, Axendia; Katie Dowling, Senior Solution Consultant, Sparta Systems Recorded: Jun 9 2010 71 mins
    The food & beverage industry is undergoing unprecedented change and increased scrutiny in light of recent high-profile quality and consumer food safety issues. Now the federal government is ready to pass legislation that will increase regulation and introduce penalties for non-compliance. Will your company be prepared if the FDA comes knocking? What lessons can food companies take from their counterparts in industries such as life sciences that have been more highly regulated for years?

    In this one hour session you will learn:
    •The status of legislative proposals on food safety and gain insight into likely outcomes of pending proposals
    •The key risk areas based on the anticipated penalties for non-compliance
    •The benefits of implementing enterprise quality systems in advance of legislative action
    •How to prepare for and survive the next generation FDA audit
    •How quality management solutions complement ERP systems

    Come learn how your company can manage your risk and company reputation in this changing environment.

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