Level: Introductory

Chocolate and Cocoa Processing

The focus of this training program is chocolate and cocoa processing. The course will guide you through the entire process, from cocoa beans to finished products. The program will emphasize the fundamental principles of chocolate and cocoa processing, including raw materials, finished products, equipment, facilities, and warehouse layouts. Upon completion of this course, you will be able… Continue reading Chocolate and Cocoa Processing

An Introduction to Oral Solid Dosage Form

The most common pharmaceutical dosage is the oral solid dosage form, which includes both tablets and capsules. There are many different ways to manufacture these products, starting with the appropriate selection of excipients all the way through the production of the finished product. Ultimately, the successful production of a tablet or capsule is dependent upon… Continue reading An Introduction to Oral Solid Dosage Form

cGMPs for Biologics

This intensive 8-hour accredited training will provide an oversight into cGMPs for Biologics, and large molecule manufacturing from development to engineering batches to Process Performance Qualification (PPQ) lots including analytical method validation. A review of vital and current Biopharmaceutical/Biologics processes will be reviewed for current Quality/Regulatory expectations. Key insights are presented for both FDA and… Continue reading cGMPs for Biologics

An Introduction to Current Good Tissue Practice (GTP)

The US FDA’s current Good Tissue Practice regulations constitute a significant compliance challenge for the Human Tissue Industry. This course is intended to provide hands-on training for anyone who works for human cell, tissue, and cellular and tissue-based products companies which must comply with CGTP. In this intensive training, we will review the Public Health… Continue reading An Introduction to Current Good Tissue Practice (GTP)

Sunscreen Basics

In the Cosmetic and Personal care market, almost everyday creams claim to offer a sun protection factor or SPF, and body products for summer holidays claim high SPF numbers. In the U.S. the sun-filters (UV absorbing molecules) are listed on a positive list, they are considered drugs that can be sold over the counter (OTC),… Continue reading Sunscreen Basics

Introduction to Softgel Manufacturing and Controls

Softgel dosage forms represent a modern take on the traditional tablet product, the most common type of pharmaceutical products produced. In the patient’s hand, a softgel can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind… Continue reading Introduction to Softgel Manufacturing and Controls

Introduction to Tablet Manufacturing by the Direct Compression Process

Solid oral dosage forms such as tablets and capsules represent the most common type of pharmaceutical products produced. In the patient’s hand, a tablet can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind the ingredients… Continue reading Introduction to Tablet Manufacturing by the Direct Compression Process

Microbiology for the Non-Microbiologist

Appropriate as a GMP Microbiological Refresher With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished products, it has become increasingly important for companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of… Continue reading Microbiology for the Non-Microbiologist

Management of Pharmaceutical Water in a GMP Environment

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility… Continue reading Management of Pharmaceutical Water in a GMP Environment

Computer System Validation: A Regulatory Overview

The ever‐increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer‐controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers,… Continue reading Computer System Validation: A Regulatory Overview