INSIGHTS ON REGULATORY COMPLIANCE

• Key Considerations For A Successful EU Orphan Drug Launch

  During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.

• Excipients And SAXS: The Detection Of Structural Aging

  A solution to obtain structural information quickly for effective quality control of pharmaceuticals during production or to study ageing effects and other properties.

• Elemental Impurities: Steering Clear Of The Big Four

  With new regulations having established a need for the testing of certain elements, correct sample preparation is crucial.

• CCI Test Method Validation For Pre-Filled Syringes

  Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. Read how method validation is used to demonstrate sufficient accuracy and reproducibility of a method, in this case to detect CCI defects at the plunger seal of a pre-filled syringe.

• Saving Money, Saving Time In Pharma Operations

  A holistic data infrastructure removes the barriers of finding, capturing, converting and organizing operational data, enabling operators and engineers to model enterprise-wide operational intelligence while reducing complexity and cost. Once this holistic data infrastructure is implemented within an organization, it becomes a foundation for building four pillars of a successful and stress-free pharmaceutical manufacturing operation.

• Raman Spectroscopy Beyond The Lab: From Loading Dock To Production

  Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.

• Container Closure Integrity Testing Method Development

  Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

• 6 Regulatory Changes Affecting Bioprocessing In China

  This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

• New Guidelines For Container Closure Integrity Testing

  Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.