Subject: Manufacturing

Flexible Film Structures in Analytical Chemistry Packaging

Flexible film offers many unique properties for the custom packaging of a product. However, without fully understanding the physical properties of the film or the packaging process, inadequate packaging can result which does not provide the proper barrier properties for the product. Such situations, if not caught during the development of the package or the… Continue reading Flexible Film Structures in Analytical Chemistry Packaging

Spray Drying: Advanced Technology Overview

This 90-minute accredited course focuses on Spray-Drying technology, a very important process in numerous industries. The course will emphasize the scientific fundamentals and practical operational aspects of Spray-Drying that are seen day-to-day in industries such as Food, Beverages, Chemicals, Pharmaceuticals, Pulp and Paper, etc. The primary goal will be to help scientists, engineers and operations… Continue reading Spray Drying: Advanced Technology Overview

Understanding the Process Validation Life Cycle

This 90-minute, accredited ON DEMAND training is intended to help you better understand and get familiar with best practices for Process Validation applicable for the highly regulated biological/pharmaceutical industry. This course is further intended to discuss the life cycle of the Process Validation system. You will learn when a process should be validated, the basic… Continue reading Understanding the Process Validation Life Cycle

Designing an Effective Environmental Monitoring Program

Determining a Cleanroom State of Control The importance of designing an effective Environmental Monitoring (EM) program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom control from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training, and practices. It… Continue reading Designing an Effective Environmental Monitoring Program

Sulfate-Free Surfactants

Surfactants play a vital role in the properties and performance of personal care and cosmetic products. Recently concerns have been expressed about the use of sulfate containing surfactants in cosmetics. The reasons for this are not always completely clear. In this 90-minute accredited training, we examine these concerns. We will discuss alternative surfactants and formulations… Continue reading Sulfate-Free Surfactants

Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-up

For both prescription and OTC pharmaceuticals, a semi-solid dosage form is a very common delivery method for the drug product. But just because they are common does not mean that they are easy to develop and manufacture. In fact, there are a whole host of issues that can arise during development and manufacture that can… Continue reading Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-up

Atomization and Spray Drying: Applied and Practical Approach

This 18-hour accredited ON DEMAND course focuses on Atomization and Spray-Drying technology, which are key processes in numerous industries. The course will emphasize the scientific fundamentals and practical operational aspects of Atomization and Spray-Drying that are seen day-to-day in industries such as Food, Beverages, Chemicals, Pharmaceuticals, Pulp and Paper, etc. The primary goal will be… Continue reading Atomization and Spray Drying: Applied and Practical Approach

Introduction to Validation Principles, Practices and Requirements

FDA regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements. This 12-hour, accredited ON DEMAND course provides an overview and introduction to Validation principles and requirements. Discussed in this program are: -Process validation -Computer System Validation -Cleaning validation -Methods… Continue reading Introduction to Validation Principles, Practices and Requirements

Setting up and Implementing Supplier Audits

Every pharmaceutical, medical device or related industry company must rely on the dependability of their suppliers to consistently provide quality materials and services. Key to this is the establishment up front of a supplier quality agreement. But even once created and agreed upon, periodic audits are necessary to ensure it is being routinely followed. The… Continue reading Setting up and Implementing Supplier Audits

Managing FDA Inspections: The FDA Investigator Cometh…Are You Ready?

In its role mandated by the FD&C Act, FDA periodically performs site inspections to ensure that Pharmaceutical and Medical Device companies are in compliance with current Good Manufacturing Practices (cGMPs). The goal of these inspections is to ensure that establishments consistently manufacture drug products of acceptable quality and minimize consumers’ exposure to adulterated drug products.… Continue reading Managing FDA Inspections: The FDA Investigator Cometh…Are You Ready?