DIA - eLearning Catalog

INTRODUCTION TO GMPs A COURSE

In this course, you’ll examine the history of GMPs, and explore the importance of training, as well as quality control and personal responsibilities. In addition, you’ll discover the importance of documentation and tracking practices.

L FEATURED TOPICS

• Procedures • Documentation • Responsibilities • Contamination Control • Inspections

KEY CONCEPTS OF PROCESS VALIDATION A COURSE

Through the use of interactive examples focused on producing a fictitious product, this program will outline the actual activities that take place before, during, and following the validation of a process. Throughout the program, you will learn terminology and concepts related to the validation of manufacturing processes, the regulatory requirements for process validation, and validation approaches. A validation life cycle model is used to explain how major elements of validation and how they relate to one another. After completing this course, you will be familiar with applicable regulatory requirements and other important aspects of process validation. The validation life cycle, which lays out the steps to effective process validation, will also be introduced.

L FEATURED TOPICS

• Why processes are validated • Process validation vs. verification • Types of processes that must be validated • Common approaches to validation • The validation life cycle

ORIENTATION TO GMP COMPLIANCE A COURSE

Many people, including those who work in the drug and medical device industries, find regulations confusing. Because FDA regulations have a direct impact on how you do your job, this interactive program is designed to take the mystery out of these regulations by giving you insight on how they are applied and interpreted. You will better understand how the FDA and your own company’s compliance professionals interpret and apply these important regulations.

Upon completion of this lesson you will be able to explain how the Food, Drug, and Cosmetic Act are tied to the Code of Federal Regulation Title 21, and how the GMPs are key elements in those regulations. In addition, you will understand how various FDA publications aid in interpreting and determining the FDA’s expectations in regards to these regulations.