Compliance

WHITE PAPERS AND CASE STUDIES

• Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
• X-Ray Inspection For Supplement Safety

  Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

• A Guide To Pharmaceutical Quality Management

  Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

• Developing An Organizational Roadmap For Post Authorization Safety Studies

  Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.

• Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

  As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

• Expectations On The Pathway To GMP For Gene-Modified Cell Therapies

  Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.

• Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine

  As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.

• Hospitality POS Reseller Relies on Mercury Payment Systems to Stay Ahead of the PCI Curve Partner education helps reseller overcome merchant objections.
• Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

  A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

• Data Collaboration Helps Novavax Accelerate Vaccine Production

  How and why this late-stage biotech implemented a data collaboration platform, Driven by its COVID-19 vaccine development and manufacturing data management complexities.

• A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program

  Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.

• WIMAX With Differentiation By Elvis Tucker, Aperto Networks The WiMAX Forum defines the profiles that any WiMAX-compliant broadband wireless access systems must support in order to achieve inter-operability. But while inter-operability is an important goal for any WIMAX-compliant system, it will not ensure optimization. Submitted by Aperto Networks