Compliance

WHITE PAPERS AND CASE STUDIES

• Serialization And Traceability Compliance In Pharma And Med Device

  Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

• Case Study: DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
• 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.

• Safety First In The Field!

  Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.

• 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...
• 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.

• Q&A: Payment Processing With Precidia Technologies Precidia has issued several press releases, through late 2008 and early 2009 regarding the TransNet solution. What is your strategy with this product? In introducing TransNet, we are offering the market an alternative to the established integrated payment model. Our solution addresses some of the limitations of the...
• 24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments

  Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.

• 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. 

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Case Study: Excavating Company Gains Environmental Compliance For Vehicle Wash Water Brownsville, Penn.-based, Brubacher Excavating, Inc. performs a full range of excavating, pipe and utility installation, roadway construction, general earth moving activities and related site development services in Southeastern Penn. Although the company washes its heavy equipment regularly, its dump trucks and tractors account for the most frequent use of its wash bay.
• 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.