From Screening to Confirmation: Integrated POPs Analysis Workflow

Manage webcast
Dirk Krumwiede, Hans-Joachim Huebschmann
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.
Oct 6 2010
84 mins
From Screening to Confirmation: Integrated POPs Analysis Workflow
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Environmental

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  • Following decades of studies, scrutiny and debate, the U.S. EPA updated its TCE’s toxicity profile in the IRIS database, dramatically lowering the toxicity value. For transactional due diligence, this more stringent limit has important implications, including markedly more extensive and expensive cleanup processes. Given the focus on vapor migration in the new ASTM Phase I ESA standard, environmental professionals need to be increasingly cautious when making REC determinations and recommendations to clients.

    Adding to the confusion is the significant variability in how regulators are using the updated TCE toxicity profile when making closure decisions at contaminated properties. For instance, U.S. EPA Regions 9, 10 and states like Minnesota, Indiana and Massachusetts (among others) have implemented profoundly different approaches to address TCE risk at contaminated sites. Thus, it is critical for environmental professionals to stay abreast of the how TCE guidance is being interpreted and applied across the country. In the latest development, the Agency for Toxic Substances & Disease Registry is proposing a dramatic change to its TCE toxicity profile for the first time in 18 years. The comment period ended on March 16, 2015, and if the update is finalized in its current form, there will be more intense scrutiny on exposure risks which will further complicate transactional due diligence.

    This timely webinar will bring together an attorney and a national subject matter expert to address the various impacts of TCE’s toxicity update on transactional due diligence. This panel will help EPs answer the following questions:

    -Does TCE in groundwater constitute a VEC and/or a REC?
    -How should an EP manage variability in TCE standards in multi-state transactions?
    -How can an EP take steps to minimize exposure to potential liability?
    -How can an EP make sense of the science and available guidance?
    -How should an EP communicate potential risks associated with TCE to clients?
  • Commercial real estate markets continue their slow recovery. As demand for loans intensifies, regulatory compliance is top of mind for financial institutions. Bank regulators are exercising strict oversight over all types of bank underwriting, including commercial appraisals. This webinar will address head-on the challenges that institutions face in meeting the latest guidance impacting the appraisal function, and what risk managers can and should be doing to survive an appraisal compliance audit.

    Attendees will receive answers to these important questions:

    • What do current guidance/regulations require of banks related to appraisals and how has that changed?
    • What specific things are bank examiners looking for in an appraisal compliance audit?
    • Are you doing everything you can to prepare your institution for the scrutiny of examiners before an audit? During an audit? After an audit?
    • What are the latest best practices that banks should include today in their appraisal policies to protect themselves during this stage of market recovery?

    EDR Insight is fortunate to have Mitch Kreeger for this timely event. Kreeger is a well-known Subject Matter Expert (SME) on various valuation, environmental and seismic risk, and regulatory compliance topics by peers nationwide. Currently, Kreeger is Chief Appraiser and Principal Consultant at Kreeger Consulting, a private appraisal/environmental/seismic risk consulting services firm that offers commercial appraisal reviews, outsourced Chief Appraiser duties, and advisory services to lenders on regulatory compliance, efficient appraisal/environmental risk functions, and effective policy updates.

    Audience:
    • Primary: Risk managers at financial institutions, particularly at community bank level
    • Secondary: Commercial appraisers
  • Exposure to professional liability ranks high on the list of any environmental professional’s concerns. In this webinar, industry veteran Anthony Buonicore will present five carefully-selected case studies where an EP was sued, highlighting how costly litigation could have been avoided. Attendees of this webinar will come away with steps that can be taken to minimize professional liability exposure when:

    • Submitting a Phase I ESA proposal
    • Conducting a Phase I ESA
    • Writing the Phase I ESA report
  • With risk management in the spotlight, environmental risk management policies are more important than ever. Environmental insurance options have evolved to offer lenders proven ways to manage risk as commercial loan originations increase in the second act of market recovery. Join us for this webinar as seasoned insiders share their insight into how insurance policies can effectively manage risk exposure. Attendees will also learn how environmental insurance can be applied to lending practices based on real world examples of claims scenarios.

    Benefits to attendees:
    • Background on the latest tools available to help lenders protect collateral on real estate loans or investments.
    • The know-how to avoid an embarrassing loss on loan portfolios due to environmental issues.
    • The latest intel on how lender environmental insurance can help lenders make more loans.

    Target audience:
    • Risk managers at community banks
    • Risk managers at national/international banks looking for a refresher
    • Credit managers and chief credit officers
    • Environmental due diligence professionals serving lenders
    • Insurance professionals
  • Vapor migration is part of the new Phase I environmental site assessment protocol from ASTM, E 1527-13. In December, the US Environmental Protection Agency blessed the new standard as compliant with the federal All Appropriate Inquiries rule, emphasizing the importance of assessing vapor migration risk as a standard part of Phase I ESAs. US EPA went even further in the December preamble and stated that vapor migration has always been a part of conducting AAI. In light of US EPA’s statements and the emphasis that assessing vapor migration is current standard practice for AAI-compliant Phase I ESAs, how is vapor being addressed in the field? If a Phase I ESA report identifies vapor migration as a Recognized Environmental Condition, or REC, what next? In today’s market of intensely short turnaround times for property transactions, is a vapor migration issue a deal killer? What are the current tools and options to investigate a vapor migration REC under transactional time constraints? When should a buyer walk away from a site potentially impacted by vapor migration? When to mitigate? How are environmental due diligence firms establishing consistent processes for recommending “next steps” for clients when vapor migration issues arise?

    This timely webinar will bring together an attorney and two leading technical experts to address head-on the various avenues that firms are taking to assist end users of Phase I ESA reports on how to address vapor migration risk during the deal making process.
  • Regulatory pressures are fundamentally impacting the way that financial institutions manage the appraisal function. Our speakers will tackle the most impactful issues for both lenders and appraisals today. An expert from the Appraisal Institute, the largest appraisal membership society in the world with 23,000+ real estate valuation experts worldwide, will share first-hand research into the challenges faced by appraisers and by lenders that rely on the technical expertise of appraisal services. Attendees will learn about the concerns commercial real estate appraisers face, and the challenges their lender clients face in finding quality appraisers to help them respond to new policies and requirements. Speakers will also share insight into the latest policies from bank regulators like the OCC and FDIC that are impacting the integration of appraisals and environmental risk management. An expert in the trenches of a small community bank will share his insights into the shifting alignment of appraisals and environmental risk management at the community bank level, the importance of having a sound policy in place and actions that banks can take to best prepare for the scrutiny of examiners.

    BENEFITS TO AUDIENCE:
    - Information on how appraisers can meet today’s top challenges, align their services with the challenges lender clients face
    - A deeper understanding of bank regulations impacting appraisals
    - An insider’s take on what bank examiners look for
    - Advice on steps banks can take to protect themselves against examiner scrutiny
    - A look into the forces that are bringing appraisals and environmental due diligence functions closer together

    PRESENTED BY:
    - Bill Garber, Director of Government and External Relations, Appraisal Institute
    - Brian Ginter, Director - Executive Staff, Diversified Real Estate Consulting Network
  • With scrutiny on lenders’ risk management policies intensifying, more and more community banks are writing their first policies or updating old ones. The OCC just raised the bar for the banks it regulates with the August release of expanded guidelines for environmental risk management that bring their policy requirements in line with those of the FDIC. What are the critical components that should be in every policy? What elements are common to most institution’s policies? How does your institution measure up to industry best practices? How is policy administered across organizations?

    Join us for this webinar as seasoned insiders selected from the ranks of a mid-sized bank and small community lender share their experiences in writing and updating environmental policies. Learn what these experts are doing to protect their institutions from environmental risk exposure, and the dangers that lenders face by not having adequate policies in place to protect them from financial and legal liability.
  • Do you have more questions than answers about the industry’s transition over to a new ASTM Phase I ESA protocol? You’re not alone.

    On August 15, 2013, the U.S. Environmental Protection Agency published a Direct Final Rule which proposes to reference the E 1527-13 standard as compliant with the agency’s All Appropriate Inquiries rule (40 CFR Part 312). The agency’s 30-day public comment period just closed and the ASTM standard moves one step closer to publication.

    Right now the #1 question in the industry is: When will ASTM E 1527-13 take effect?

    At this webinar, two of the experts closest to the ASTM process will share the latest status of the AAI rule amendment and publication of the new Phase I ESA standard.

    There are a number of moving pieces in play right now. Tune into this event to learn the latest on the ASTM front, the hot-button issues raised during the public comment period, what happens to E 1527-05 and more. It is an important time for the industry as it prepares to put a new standard into effect and this event will help keep environmental professionals abreast of the process as it unfolds.

    Speakers:

    Julie Kilgore, President, Wasatch Environmental, Inc., Chair of ASTM E50 Committee on Environmental Assessment, Risk Management and Corrective Action and Chair of the E1527 Task Group

    William Weissman, attorney, member of ASTM E50 Executive Subcommittee, retired partner of Venable LLP, Washington, DC
  • Change is in the air on the vapor intrusion front. Literally and figuratively. On April 16, the U.S. Environmental Protection Agency released a draft document, the OSWER Final Guidance For Assessing And Mitigating The Vapor Intrusion Pathway From Subsurface Sources To Indoor Air — External Review Draft for public comment. The release of EPA’s guidance comes just months before ASTM is poised to release a revised version of E 1527 that adds definitions of migrate/migration to address the vapor pathway as a potential conduit for contamination.

    As attention being placed on vapor risk increases, environmental professionals need to stay abreast of the changes and their implications. With the long-awaited federal guidance now out for public comment, environmental due diligence professionals, lenders, as well as prospective purchasers of properties like drycleaners, gas stations, and other types of properties impacted by petroleum or solvents have a valuable resource for understanding VI risk, assessing it and ultimately, managing it as appropriate for their own risk tolerance. Join us at this webinar to hear the perspectives of three experts on:

    • The implications of the federal vapor guidance and an insiders’ unique take on hot button issues;
    • How one environmental professional talks to his clients about vapor risk and protects their liability exposure; and
    • How vapor risk is being mitigated and managed in today’s deals.
  • For lenders operating in the shadow of the Dodd-Frank Act, CFPB and other regulatory enforcement agencies are focusing their efforts on consumer protection, disclosure and transparency and deem these critical to all areas of an institution’s compliance and operation. A dizzying array of new rules and regulations, often disruptive to existing operations, are raining down upon the mortgage lending industry. Now, however, it’s not enough to simply be aware of emerging rules and regulations. Little known requirements and regulations which have been on the books for years without being enforced are now getting renewed attention from those agencies, likely opening up an entirely new front in the uphill battle to stay compliant. One of the greatest potential risks to lenders arises from requirements for residential property appraisals and evaluations. It is likely we will see stricter environmental underwriting and more regulatory scrutiny on lenders’ risk management policies. Discover now where lenders are most at risk, and learn about cost-effective measures that can be taken to stay out of the regulatory crosshairs.

    The presenters will:

    • Identify existing rules and regulations, little-known and long unenforced, that are likely to be revitalized by regulatory enforcers;
    • Spell out the specific risks that residential property contamination, including vapor mitigation, will pose to a mortgage lender;
    • Explain how the gamut of new and existing requirements will impact traditional due diligence requirements; and
    • Predict the possible financial impact upon lenders, as well as offering potential solutions for risk mitigation.
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  • Capsules for Use in Dry Powder Inhalers (DPIs) in Early Phase Dev Recorded: Jun 28 2011 69 mins
    Matt Richardson, Capsugel; Massimo Moratto, Aptuit; Mike Savill, Capsugel
    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 Recorded: Jun 1 2011 75 mins
    Gary Nowacki, TraceGains, and Jack Kennedy, Chelsea Milling Company
    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 Recorded: Mar 16 2011 76 mins
    Dr. James Love, New York Consortium on Membrane Protein Structure, and Mark Dumont, University of Rochester Medical Center
    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!

    Topics:
    - 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 Recorded: Jan 25 2011 63 mins
    Dipankar Ghosh, Ph.D., Tina Hemenway, Ph.D.,Thermo Fisher Scientific
    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 Recorded: Jan 11 2011 75 mins
    Brady Carter, Research Scientist, Decagon Devices
    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 Recorded: Oct 28 2010 58 mins
    Phillip Butler
    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 Recorded: Oct 6 2010 84 mins
    Dirk Krumwiede, Hans-Joachim Huebschmann
    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 Recorded: Sep 14 2010 64 mins
    Ken Rosnack, Waters Corporation
    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 Recorded: Jul 13 2010 85 mins
    David Edwards, Capsugel; Tim Scott, Pharmatek Laboratories; Joseph Forth, AMRI
    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? Recorded: Jun 9 2010 71 mins
    Ed Johnson, Esq. Regulatory Analyst, Axendia; Katie Dowling, Senior Solution Consultant, Sparta Systems
    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.
  • Dewpoint Moisture Content: A New Method Moisture Content Analysis Recorded: Jun 8 2010 69 mins
    Brady Carter, Decagon Devices
    Dewpoint Moisture Content: A New Method for Moisture Content Analysis

    This seminar will provide information about the Dewpoint Moisture Content method, a new method for moisture content analysis. Moisture content is a quantitative measurement of the amount of water in a product. It is primarily measured using loss on drying techniques where water (and often other volatiles) is driven out of the product by exposure to elevated temperatures inside an oven. Moisture content provides valuable information about yield, product purity, and ingredient concentration. Water activity represents the energy status of the water in the system. It provides valuable information about microbial, chemical, and physical stability. The primary method for measuring water activity is chilled-mirror dewpoint method. Moisture content and water activity are currently measured using separate techniques or instruments. The Dewpoint Moisture Content method makes it possible to measure both analyses in one instrument. To work, the Dewpoint Moisture Content method requires an understanding of the relationship between water activity and moisture content. This seminar will describe this relationship, called a moisture sorption isotherm, and how it can be used to determine moisture content using dewpoint derived water activity values. The accuracy and precision of the Dewpoint Moisture method will be reported and compared to other moisture content methods.

    5 Major Learning Objectives:

    1) The Dewpoint Moisture Content method will be introduced

    2) The relationship between water and moisture content will be described.

    3) Development of a calibration model relating moisture content to water activity will be described.

    4) Moisture content results for the Dewpoint Moisture Content method will be reported.

    5) The Dewpoint Moisture Content method will be compared to other methods.
  • BASF Innovation in Tablet Color Coating Systems Recorded: Apr 29 2010 69 mins
    Dr. Thorsten Schmeller and Philip Butler
    In this webinar you will learn how to: -Create your own colors -Improve production efficiencies -Increase process robustness -Reduce process complexity with Kollicoat® IR Coating Systems – a readily dispersible polymer with excellent handling properties.
    Webinar speakers include: Dr. Thorsten Schmeller Head of Global Marketing New Products Pharma Ingredients and Services, Care Chemicals Division BASF SE, Germany
    Philip Butler Technical Sales Manager for Coatings in North America Pharma Ingredients and Services, Care Chemicals Division BASF Corporation, United States
  • What’s in your vial? Best practices for microbial QC strains Recorded: Apr 28 2010 84 mins
    Elizabeth Kerrigan, Jaspreet Sidhu, Ph.D.
    What’s in your vial? Best practices for maintaining microbial QC strains.

    Speakers:
    Elizabeth Kerrigan
    Director, Standards and Certification,
    Microbiology, Biodefense and Emerging Infectious Diseases
    ATCC

    Jaspreet Sidhu, Ph.D.
    Vice President of Business Development and Pharmaceutical Microbiology
    Molecular Epidemiology, Inc.

    Seminar Overview:
    In the pharmaceutical and personal care industries, products, processes and environments are quality control tested to prevent microbial contamination. Microbial strains with confirmed identity, viability and purity, produced by meticulous laboratory procedures that minimize subculturing, are important components of quality control testing programs. Responding to industry demands for rapid microbiological testing, instrumentation and associated databases have been developed that allow for the standardized testing of phenotypic and genotypic traits across a wide array of microorganisms. A polyphasic approach to identification provides strain confirmation and avoids the pitfalls of misidentification, painful recalls and regulatory repercussions. Case studies will be provided to illustrate key points.

    Major Learning Objectives:
    •Understanding the importance of polyphasic microbial identification
    •Best practices for maintaining the stability and integrity of microbial QC strains.
    •Importance of confirming microbial identification – pitfalls of misidentification.
  • Incorporating Water Activity Testing in New Pharma Initiatives Recorded: Apr 8 2010 81 mins
    Brady Carter, Research Scientist – Decagon Devices Inc.
    Incorporating Water Activity Testing in New Pharmaceutical Initiatives

    This seminar will provide an overview of effective utilization of water activity as part of new pharmaceutical initiatives such as ICH and QBD. USP 1112 outlines strategies based on water activity that can reduce the amount of microbial limit testing needed for products with lower water activities. These strategies can be applied to drug release quality programs that are developed using ICH or QBD guidelines. The primary goal of these initiatives is to create risk-based, science backed quality programs. In terms of microbial safety of drug products, the new quality initiatives indicate that products that are “dry” are candidates for reduced microbial limits testing. Water activity is the only effective screen for “dry” conditions that prevent microbial spoilage as evidenced in scientific literature while moisture content is not. Water activity is also related to other critical quality attributes such as dissolution, excipient performance, and degradation of API. Utilization of water activity testing requires an understanding of water activity and this seminar will define water activity and describe methods for accurately measuring it. The seminar also will discuss the relationship between water activity and critical quality attributes and discuss strategies for implementing water activity testing in drug quality programs.

    5 Major Learning Objectives:

    1) What is water activity?
    2)How are water activity and moisture content different?
    3)How is water activity measured?
    4)What critical quality attributes is water activity related to?
    5)How can water activity be used with ICH?
    6)How can water activity be used with QBD?
  • Reducing Bottlenecks In GxP Laboratories Recorded: Jan 19 2010 64 mins
    Chris Stumpf, Ph.D.
    Reducing Bottlenecks In GxP Laboratories With Electronic SOP Document And Workflow Systems

    In the QC laboratory, adherence to Good Manufacturing Practice (GMP) guidelines necessitates the need to maintain thorough documentation to ensure strict compliance with established procedures. Completing paper documents and ensuring their authenticity creates a burdensome bottleneck for the QC laboratory. This presentation will discuss strategies for using an electronic SOP document and workflow system to boost laboratory productivity.

    • Electronic SOP document and workflow systems improve SOP completion times, reduce procedural and transcription errors, and reduce review & sign-off times

    • A more efficient SOP documentation process translates into a more efficient documentation workflow, more accurate records, and faster product release.

    • An electronic SOP documentation system offers the opportunity to address the three major tenets of Lean Process manufacturing: eliminate waste, improve workflows, and improve quality.

    SPEAKER

    Chris Stumpf, Ph.D.
    Senior Product Marketing Manager, Informatics
    Waters Corporation

    Chris joined Waters in 2001 after earning his Ph.D. in Analytical Chemistry and Mass Spectrometry from Purdue University in 2000, and held a post doctoral position at the University of Cincinnati Medical School conducting proteomics research. During his doctorate and post-doctorate education, he became keenly interested in informatics solutions to manage and mine analytical data
  • A Complete Moisture Analysis Recorded: Jan 13 2010 85 mins
    Brady Carter
    This seminar will highlight the importance of a complete moisture analysis consisting of both water activity and moisture content. Definitions for water activity and moisture content will be established with a particular focus on their differences. Methods for measuring water activity and moisture content as well as techniques for obtaining accurate measurements will be highlighted. The relationship between water activity and moisture content, referred to as a moisture sorption isotherm, will be described. Practical applications for water activity, moisture content, and moisture sorption isotherms will be detailed. These applications will cover both product safety and quality including: microbial safety, shelf life, ingredient mixing, temperature abuse, product formulation, caking and clumping, and package performance.

    5 Major Learning Objectives:

    1) What is water activity and moisture content?

    2) How are water activity and moisture content different?

    3) How are water activity and moisture content measured?

    4) What is a moisture sorption isotherm?

    5) How do water activity and moisture content influence product safety and quality?

    6) How can the relationships between moisture content and water activity be used to improve product formulation?
  • The Science of Food Profiling Recorded: Nov 10 2009 55 mins
    Dr. Tim Jenkins
    The Science of Food Profiling: Determining the Adulteration, Authenticity and Origin of Foods

    With reports of 5 to 10% of global food trade involving counterfeit goods, regulatory agencies and food manufacturers are compelled to employ programs that help ensure consumer safety, protect trade markets, maintain product quality and preserve brand image.

    This webinar will demonstrate how the latest analytical instrumentation and data analysis software can assist food testing laboratories in the determination of food adulteration, authenticity and origin.

    • Liquid chromatography and mass spectrometry are key analytical technologies for food profiling. The application and advantages of these techniques will be discussed.

    • Employing chemometrics software for automated data analyses can yield critical information for food testing laboratories. The approach facilitates the identification of differences or similarities between brands or manufacturing batches. This methodology will be examined.

    • Examples of edible oil, tea and fruit juice food profiling applications will be shown.

    Presenter

    Dr. Tim Jenkins is part of Waters Chemical Analysis Market Development group where he leads the Business Operations team. This group has particular expertise in food testing and environmental applications and addresses global market development issues. Prior to joining Waters Dr. Jenkins gained over 15 years experience of practical mass spectrometry and technical management in a variety of environments including academia, corporate R&D and contract analysis laboratories.
  • Innovative 3rd Generation Coating: BASF’s Kollicoat Recorded: Nov 2 2009 56 mins
    Vaishali Tawde and Eric Liu
    Innovative key features of the new patented PEG-PVA graft polymers are the low viscosity of the polymer solution, outstanding flexibility of the film and extremely rapid dissolution of coating. In terms of viscosity alone this new technology offers significant advantages over cellulose derivatives. Sprayable dispersions at high solids concentrations which are not sticky and fast drying ensures gains in productivity and process costs. You will gain an in-depth knowledge about these new PEG-PVA graft polymers as coatings and the proper formulation and the best process parameters for excellent performance in finished solid dosage forms. Ms. Vaishali Tawde, Technical Services Manager, South Asia, BASF India Dr. Eric Liu, Senior Technical Marketing Manager, BASF China
  • Food Safety Certification: Get the Abridged Version Recorded: Oct 8 2009 87 mins
    Catherine Francois, Kathleen Wybourn and Robert Haydu
    How do I get started with Food Safety Certification? What's the process?
    What are the GFSI benchmarked standards and which is best for my organization?

    Do these questions sound familiar? Do you have even more? Attend this information-packed webinar to get the answers to your questions and valuable details you need about Food Safety Certification.

    Catherine Francois, Consumer Goods Forum (CIES/CFSI)

    Kathleen Wybourn, DNV

    Case Study Speaker: Robert Haydu, Wm. Wrigley Jr. Company

    Attendees to the webinar that are interested in pursuing certification and using the IFS standard, will receive a free copy of the standard (a $57 value) and one free license to “auditXpress”, the IFS internal auditor software (a $290 value). To obtain these items, you must attend the webinar! (Restrictions apply, limited quantities available)
  • Hot Melt Extrusion for Poorly Soluble Drugs Recorded: Oct 6 2009 77 mins
    Scott T. Martin, Thermo Fisher, Karl Kolter, BASF
    Hot Melt Extrusion (HME) is becoming an important technology within the Pharmaceutical Industry as a means for formulating poorly water-soluble active pharmaceutical ingredients (API’s). Additionally, HME provides greater drug bioavailability. This Webinar will cover:

    • A review of Hot Melt Extrusion Technology.
    • Modification to the traditional extrusion system for pharmaceutical needs.
    • An economically-feasible continuous process and solvent-free manufacture.
    • The role of polymers and plasticizers.
    • The use of low temperatures to minimize API degradation.
    • Optimization of HME Formulation and Process.

    Scott T. Martin, Senior Application Specialist, Thermo Fisher Scientific

    Dr. Karl Kolter, Ph.D., Head of Global R&D Project Management Excipients
    BASF SE, Germany, Pharma Ingredients and Services

    BASF reserves the right to limit access to this event.
Trends and Developments
This channel will provide webinars that focus on the unique niche of post-discovery development and validation as well as webinars that examine current products, technologies. and philosophies used in laboratories; tracks the deployment of tools that processors and the food service industry professionals use to ensure safe and consistent products.

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  • Title: From Screening to Confirmation: Integrated POPs Analysis Workflow
  • Live at: Oct 6 2010 3:00 pm
  • Presented by: Dirk Krumwiede, Hans-Joachim Huebschmann
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