The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
Equipment Qualification in the GxP Environment
Whether your operation is covered by GMP, GLP, or GCP, there is a regulatory requirement to ensure that all equipment used has been properly demonstrated and documented to be functioning properly. Commonly referred to as Installation Qualification, Operational Qualification, and Performance Qualification, IQ/OQ/PQ provides the framework under which this process can be appropriately performed. Overlooking… Continue reading Equipment Qualification in the GxP Environment
Read MoreStatistics and Probability Tools for the Non-Statistician
Focus on Life Sciences and Manufacturing Data collection, modeling and analysis, play a vital role in a number of human activities. In research, it is vital to master the proper techniques to collect data, apply to a model and drive conclusions. In manufacturing, it is crucial to understand the main variables in the process, develop… Continue reading Statistics and Probability Tools for the Non-Statistician
Read MoreTacical Auditing: Tools and Techniques for a Better Audit Approach
Many organizations conduct quality audits because they are required to do so by their company or a regulatory agency. Others conduct the audits because they have been a good check for compliance to the regulatory standards. While all these reasons have varying degrees of validity, none of them articulate the best reason for having a… Continue reading Tacical Auditing: Tools and Techniques for a Better Audit Approach
Read MoreApplied Statistics: Design of Experiments and Taguchi Methods
Focus on Life Sciences and Manufacturing Taguchi methods provide powerful tools to identify the critical process variables, understand the impact to society if deviating from standards and techniques to test multiple variables simultaneously. This 90-minute accredited training will provide an introduction to powerful methodologies to develop products and troubleshoot processes in a shorter time, as… Continue reading Applied Statistics: Design of Experiments and Taguchi Methods
Read MoreSuccessful FDA Inspections: Essential Preparation and Management Tools
Regulatory inspections should demonstrate that your company is operating according to proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate the ways in which your quality systems assure this state of control. The arrival of a Regulatory Investigator can be a daunting experience. In… Continue reading Successful FDA Inspections: Essential Preparation and Management Tools
Read MoreApplied Statistics: Statistical Process Control
Focus on Life Sciences and Manufacturing Product variability can have costly consequences for a manufacturer, ranging from rework, scrap, recalls all the way up to severe damage to a business reputation. This 90-minute accredited training course will introduce the attendees to tools that will help fight product variability in the design stage, monitor the behavior… Continue reading Applied Statistics: Statistical Process Control
Read MoreLyophilization Formulation and Process Development
Lyophilization is a very common technique used in preparing finished drug products. Yet there are many problems that can arise in production if the process has not been carefully developed. Without a good understanding of the development of this formulation and the process, these problems can readily occur. This 2-hour accredited course will provide a… Continue reading Lyophilization Formulation and Process Development
Read MoreImplementing a Change Control Quality System Successfully
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Implementing a Change Control Quality System Successfully
Read MoreApplying Quality Risk Management
he purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Applying Quality Risk Management
Read MoreCAPA: Definition, Plan and Program
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading CAPA: Definition, Plan and Program
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