Full player and game projections Winning Fantasy advice, analysis, and DFS lineups Advanced rankings from 10,000 simulations. I use Tes for resources – currently in my department we're developing new schemes of work for a variety of different sports and there's a lot already on Tes so it seems crazy to restart something new, so we just adapt resources that we find on Tes.
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Developing An Automated GxP Workflow Integrated With 21 CFR Part 11The electronic records and electronic signatures (ERES) regulations, 21 CFR Part 11 and EU Annex 11, provide life sciences companies an opportunity to reap the organizational benefits of paperless record-keeping systems.
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- Using Production And Postmarket Data To Validate FMEA Assumptions
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.
- 3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers
Amid this opportunity for generic drug makers to capitalize on patent expiration, they’re facing struggles around pricing power. COVID-19 also exposed the fragility of supply chains that were built with economic efficiency rather than resiliency in mind.
- An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019.
- Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.
- 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement
This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.
- Facility Engineering, Design, & Construction Tips For Up-Start Biotech Companies
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.
- Seeing Double: Using Digital Twins To Improve Pharma Processes
The pairing of the virtual and physical worlds not only enables systems to be adapted or repaired from afar, but the approach also further enables the analysis of data and monitoring of systems to avoid problems before they even occur.
- Is It Time To Stop Using Mean Kinetic Temperature (MKT) In Pharma Storage & Transport?
MKT continues to be proposed in USP chapters <659> and <1079> and is presented as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variation. However, there is too little or no emphasis on the physics or chemistry behind the impact of temperature excursions on biological drug products and other contemporary drugs.
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- How Can Outsourcing Buffer Preparation Help Meet The Urgent Need For A SARS-CoV-2 Vaccine?
As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecule on a global scale. In this planning, the preparation of process liquids and buffers should be considered.
- Addressing The Evolving Needs Of Variable Drug Delivery Regimens
Pharmaceutical companies continue to advance their clinical development pipelines to develop new and more sophisticated biologics. To be successful, they will need a solution that will enable the delivery and successful commercialization of complex biologics. This article describes a device designed specifically to address the rapidly evolving needs of the pharma industry and meet patient requirements.
- The Significant Need For Flexible Aseptic Filling And Isolation Systems In Pharma
Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes and bottles) with powders and/ or liquid solutions. Manufacturing staff, equipment and premises are all subject to stringent quality controls – and for good reason: patient safety. This document intends to provide information on the latest status, trends and technologies in parenteral filling equipment.
- Enabling Biologic Drug Delivery Of Volumes Beyond 1 mL
As the biological drug design space evolves toward formulations with larger dose volume and higher viscosity, the device industry is adapting by developing more innovative delivery systems. To accommodate these advances, delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
- The Use Of Cell-Free Synthesis In The Future Of Modern Medicine
Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.
- Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation
Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.
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We all within this and every industry, endeavor to get back to full productivity, which requires production. When production happens, so to do procedural errors. This guide is a critical look at the best and most fundamental methods employed over many years to help innumerable companies prosper. The net result of this information sharing is that the future of healthcare, in all of its forms, gets better for humanity. We can all only benefit from better approaches to our work and smarter problem-solving.
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