HPLC (High Performance Liquid Chromatography): Basics – 101

HPLC is one of the most widely used and versatile analytical instruments in the laboratory today. Because of the many different modes of operation, it can be difficult for many to understand some of its complexities. But with proper training, HPLC can be the tool of choice for the analytical chemist. This HPLC course is… Continue reading HPLC (High Performance Liquid Chromatography): Basics – 101

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HPLC (High Performance Liquid Chromatography): Method Development

This HPLC course will benefit the personnel with some HPLC experience who are developing or optimizing HPLC methods. This 90- minute accredited course will include discussions of the theory of Reversed and Normal Phase, Ion Pairing, and Ion-Exchange Methods. It will also give basic starting points on method development and method evaluation of these methods.… Continue reading HPLC (High Performance Liquid Chromatography): Method Development

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HPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins

This 90-minute accredited ON DEMAND course will include discussions of the theory of SEC, Reversed Phase, Ion-Exchange, Hydrophobic Interaction, and Protein Affinity Chromatography. It will also give basic starting points on method development and method evaluation of these methods. The course is designed to give personnel with some HPLC experience a broader scope for how… Continue reading HPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins

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Analytical Methods Validation for FDA Compliance

One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process… Continue reading Analytical Methods Validation for FDA Compliance

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Sterilization Professionals Certification

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification

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Drug Product Stability and Shelf-Life

“An Intensive Review of Technical and Regulatory Aspects No drug product enters the marketplace without adequate stability data first. While ICH has harmonized and standardized the approach to performing stability, a number of challenges are still routinely faced while conducting stability testing. Since inadequate stability can lead to product introduction delays, all drug companies need… Continue reading Drug Product Stability and Shelf-Life

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