Subject: QA/QC

FDA Case Scenarios: Best Practices for Managing Inspection Situations

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 FDA Case Scenarios: Best Practices for Managing Inspection Situations

Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations

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 Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

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 Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

Managing Effective Regulatory Inspections and 483 Responses

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 Managing Effective Regulatory Inspections and 483 Responses

Introduction to Cartoning: Carton Packaging – Types and Technologies

A carton, for many types of products, is the final package that the consumer/patient sees for making that all important purchase decision. As such, any deficiencies in how it looks or feels can steer their purchase towards a competitor’s product. Only through a thorough understanding of its proper selection, development, and manufacturing can a cartooned… Continue reading Introduction to Cartoning: Carton Packaging – Types and Technologies

Tacical 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

Successful 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

Statistics 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

Applied 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

Applied 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