Recorded Webinars

July 26, 2011 Chemical imaging is an analytical technique that combines digital imaging with spectroscopy to characterize materials in various drug delivery systems, including nasal spray and inhalation products, semi-solids, solids, transdermal and controlled release systems, as well as medical devices. From determining a polymorphic form to evaluating the particle size distribution of an active

Authors & ContributorsDavid Exline July 01, 2015 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Highlighted Topics An

April 27, 2016 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Case Studies in Foreign Particulate Analysis will

Authors & ContributorsDavid Exline July 01, 2015 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufactures. Manufactures often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. Highlighted Topics

Authors & Contributors Emily Landsperger February 16, 2016 Glass delamination is a phenomenon which can occur when top layers of a glass surface separate and flake off or detach from the inner surface, typically in the microscopic range. Glass delamination is the result of several factors including the product formulation, the glass resistance and the

Authors & ContributorsCara Plese July 27, 2016 Foreign particulate in drug products originate from a variety of sources. Such sources can include machinery used in drug manufacturing, drug packaging components, cleaning utensils and products, personnel wearing personal protective equipment (PPE) and laboratory surfaces. Typical contaminants include polymers, fibers, burnt material and metallic particulate. Hair is

October 15, 2015 Next Breath and Gateway Analytical will present their OINDP Webinar Series for Dry powder Inhalers (DPIs), pressurized Metered Dose Inhaler (MDIs), and Nasal drug products which are complex delivery systems and their development require key specialized expertise. Next Breath and Gateway Analytical are pleased to present a webinar to provide a comprehensive

Authors & ContributorsRebekah ByrneDavid ExlineNovember 18, 2015 Glass delamination is a phenomenon which can occur in parenteral drugs stored in glass containers.  By interaction of the drug product with the vial surface, the glass surface will sometimes break down, causing the layers to separate; ultimately this results in the presence of small glass flakes, known

Authors & ContributorsDavid Exline January 23, 2019 Topics covered include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and a review of case studies. The presentation also provides FDA guidance related to particle size distribution (PSD) and regulatory considerations for PSD

January 22, 2013 The FDA stated in their 2007 Critical Path Opportunity for Generic Drugs that “If the drug particle size distribution of test and reference products can be demonstrated to be equivalent, then nasal spray suspensions could be treated like nasal spray solutions. The critical path opportunity is to develop methods to measure drug particle size in

Authors & ContributorsRebekah Byrne June 05, 2014 Do you find you’re not getting the whole picture using your current testing methods to determine a material’s chemistry? Would a complete understanding of a material’s molecular structure aid in the development of a new product or determine the root-cause of a product failure during manufacturing? Incorporating Raman

Authors & ContributorsRebekah ByrneDavid Exline March 30, 2013 This webinar was designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of various materials, ranging from adhesives and polymers to plastics and glass. During this webinar, our presenters provided an overview of RCI and the type of data that can be generated

May 12, 2012 Screening for polymorphs is crucial during drug development, since the crystal form of the active pharmaceutical ingredient (API) directly correlates with its pharmacokinetic properties.  The ability to image and detect spatially variable changes in the drug substance becomes important in determining the drug products efficacy and performance and has significant impact on

Authors & Contributors Rebekah Byrne David Exline May 09, 2012 Failures in pharmaceutical products may range from issues with delamination and  packaging failures to polymorphs arising in the pharmaceutical product.This webinar is designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This

Authors & ContributorsAntonio ScatenaFebruary 04, 2014 Glass delamination can be a costly problem for pharmaceutical drug vial manufactures. For one vial manufacturer glass delamination can cause the recall of thousands of vials of drug product. In this webinar, you will learn about the common types of problems caused by glass delamination in pharmaceutical vials and the

Authors & ContributorsDavid Exline May 16, 2012 Medical devices such as inhalers tend to experience wear debris, which can cause a number of quality issues.  Characteristics of wear debris, including particle size and shape distribution, number of particles and chemistry is important to assess for specific medical devices. This webinar provides an overview of wear

May 11, 2012 Content uniformity of a drug product has a direct impact on product performance, quality and efficacy.  Raman and near-infrared chemical imaging are novel techniques used to provide an accurate, timely and cost-effective method, which is important when evaluating a drug product’s content uniformity.  By using these techniques, drug developers can ensure the

Authors & ContributorsDavid Exline April 02, 2013 The overall objective of a solid quality foundation in the evaluation of particle contamination analysis of inhalables is based on many things. The complete evaluation and root cause analysis of foreign particulate matter, as well as the affects of particulate on product quality, are essential when evaluating the

Authors & ContributorsDavid ExlineMarch 26, 2014 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufacturers. Manufacturers often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. This webinar offers

May 04, 2017 According to a 2007 report Measuring Trends in the Development of New Drugs: Time, Costs, Risks and Returns by J.A. DiMasi, companies spend an estimated $1.2-$1.3 billion on research and development for each approved drug due to the increasing complexity of the research and development process—particularly clinical trials. That’s a $500 million

July 26, 2011 Chemical imaging is an analytical technique that combines digital imaging with spectroscopy to characterize materials in various drug delivery systems, including nasal spray and inhalation products, semi-solids, solids, transdermal and controlled release systems, as well as medical devices. From determining a polymorphic form to evaluating the particle size distribution of an active

Authors & Contributors Rebekah Byrne David Exline May 09, 2012 Failures in pharmaceutical products may range from issues with delamination and packaging failures to polymorphs arising in the pharmaceutical product.This webinar is designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This

May 11, 2012 Content uniformity of a drug product has a direct impact on product performance, quality and efficacy.  Raman and near-infrared chemical imaging are novel techniques used to provide an accurate, timely and cost-effective method, which is important when evaluating a drug product’s content uniformity.  By using these techniques, drug developers can ensure the

May 12, 2012 Screening for polymorphs is crucial during drug development, since the crystal form of the active pharmaceutical ingredient (API) directly correlates with its pharmacokinetic properties.  The ability to image and detect spatially variable changes in the drug substance becomes important in determining the drug product’s efficacy and performance and has a significant impact

Authors & ContributorsDavid Exline May 16, 2012 Medical devices such as inhalers tend to experience wear debris, which can cause a number of quality issues.  Characteristics of wear debris, including particle size and shape distribution, number of particles and chemistry is important to assess for specific medical devices. This webinar provides an overview of wear

January 22, 2013 The FDA stated in their 2007 Critical Path Opportunity for Generic Drugs that “If the drug particle size distribution of test and reference products can be demonstrated to be equivalent, then nasal spray suspensions could be treated like nasal spray solutions. The critical path opportunity is to develop methods to measure drug particle size in

Authors & ContributorsRebekah ByrneDavid Exline March 30, 2013 This webinar was designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of various materials, ranging from adhesives and polymers to plastics and glass. During this webinar, our presenters provided an overview of RCI and the type of data that can be generated

Authors & ContributorsDavid Exline April 02, 2013 The overall objective of a solid quality foundation in the evaluation of particle contamination analysis of inhalables is based on many things. The complete evaluation and root cause analysis of foreign particulate matter, as well as the affects of particulate on product quality, are essential when evaluating the

Authors & ContributorsAntonio ScatenaFebruary 04, 2014 Glass delamination can be a costly problem for pharmaceutical drug vial manufactures. For one vial manufacturer glass delamination can cause the recall of thousands of vials of drug product. In this webinar, you will learn about the common types of problems caused by glass delamination in pharmaceutical vials and the

Authors & ContributorsDavid ExlineMarch 26, 2014 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufactures. Manufactures often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. This webinar offers

Authors & ContributorsRebekah Byrne June 05, 2014 Do you find you’re not getting the whole picture using your current testing methods to determine a material’s chemistry? Would a complete understanding of a material’s molecular structure aid in the development of a new product or determine the root-cause of a product failure during manufacturing? Incorporating Raman

Authors & ContributorsDavid Exline July 01, 2015 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Highlighted Topics An

Authors & ContributorsDavid Exline July 01, 2015 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufactures. Manufactures often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. Highlighted Topics

October 15, 2015 Next Breath and Gateway Analytical will present their OINDP Webinar Series for Dry powder Inhalers (DPIs), pressurized Metered Dose Inhaler (MDIs), and Nasal drug products which are complex delivery systems and their development require key specialized expertise. Next Breath and Gateway analytical are pleased to present a webinar to provide a comprehensive

Authors & ContributorsRebekah ByrneDavid ExlineNovember 18, 2015 Glass delamination is a phenomenon which can occur in parenteral drugs stored in glass containers.  By interaction of the drug product with the vial surface, the glass surface will sometimes break down, causing the layers to separate; ultimately this results in the presence of small glass flakes, known

Authors & Contributors Emily Landsperger February 16, 2016 Glass delamination is a phenomenon which can occur when top layers of a glass surface separate and flake off or detach from the inner surface, typically in the microscopic range. Glass delamination is the result of several factors including the product formulation, the glass resistance and the

April 27, 2016 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Case Studies in Foreign Particulate Analysis will

Authors & ContributorsCara Plese July 27, 2016 Foreign particulate in drug products originates from a variety of sources. Such sources can include machinery used in drug manufacturing, drug packaging components, cleaning utensils and products, personnel wearing personal protective equipment (PPE) and laboratory surfaces. Typical contaminants include polymers, fibers, burnt material and metallic particulate. Hair is

May 04, 2017 According to a 2007 report Measuring Trends in the Development of New Drugs: Time, Costs, Risks and Returns by J.A. DiMasi, companies spend an estimated $1.2-$1.3 billion on research and development for each approved drug due to the increasing complexity of the research and development process—particularly clinical trials. That’s a $500 million

Authors & ContributorsDavid Exline January 23, 2019 Topics covered include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and a review of case studies. The presentation also provides FDA guidance related to particle size distribution (PSD) and regulatory considerations for PSD