Laboratory Operations Training Courses

CGMP Essentials

CGMP Essentials

Laboratory Operations Training Courses

Duration: 0.17 Hrs

Course Level: Fundamental
Languages: English
Capability: Audio, Video, MobileReady

In this online interactive course, we’ll be looking at change control. We’re going to discuss why we need change control and what that process looks like. You’ll see what areas are typically governed by change control. We’re also going to look at the considerations you should have regarding how the change will impact the system, how you’re going to implement the change, and follow the proper notification procedure.

Learning Objectives

By the end of this course, you will be able to:

  • Discuss the importance of change control and its role in the pharmaceutical industry
  • Identify areas that are governed by change control
  • Recall key components of the change control process
  • List the regulatory requirements for making the change

Duration: 0.17 Hrs

Course Level: Fundamental
Languages: English
Capability: Audio, Video, MobileReady

As more and more data is being generated in the pharmaceutical world, the integrity of that data must be protected. In this data integrity course, employees will understand what data is, what the regulatory expectations are for data, the controls used, good documentation practices and what kinds of data integrity issues exist.

Learning Objectives

By the end of this course, you will be able to:

  • Define data integrity
  • Explain how data should be handled
  • Identify what systems are needed to control data integrity
  • List the consequences of data integrity issues

Duration: 0.17 Hrs

Course Level: Fundamental
Languages: English
Capability: Audio, Video, MobileReady

Errors and issues happen. When they do, our employees need to know how to investigate these occurrences and how to prevent their recurrence. Deviation and CAPA walks employees through steps to take when performing a root cause analysis and the CAPA process.

Learning Objectives

By the end of this course, you will be able to:

  • Define deviation
  • Identify proper corrective and preventative actions
  • Describe the parts of a deviation
  • List the factors considered during root cause analysis

Duration: 0.17 Hrs

Course Level: Fundamental
Languages: English
Capability: Audio, Video, MobileReady

One of the easiest cGMP compliance practices is good personal hygiene. In this course, employees will learn why good personal hygiene is important and measures they can take to protect themselves, fellow employees and our customers.

Learning Objectives

By the end of this course, you will be able to:

  • List practices and procedures co-workers should know pertaining to Good Personal Hygiene.
  • State the appropriate measures co-workers should take when not feeling well.
  • Discuss the approved method to effectively sanitize hands.

Duration: 0.17 Hrs

Course Level: Fundamental
Languages: English
Capability: Audio, Video, MobileReady

As a new pharmaceutical employee, it is important to understand the rules and regulations that govern the pharmaceutical business. Introduction to cGMP will educate all employees on the history of the US FDA, why we have good manufacturing practices and why they are important not only to our business, but for the health and safety of our consumers. In this online interactive course, we will discuss current good manufacturing practices, how they came about, and why they are important to the day-to-day quality standards set within our organizations.

Learning Objectives

By the end of this course, you will be able to:

  • Recall the historical origins of cGMP
  • Define cGMP
  • Explain the importance of cGMP
  • Describe how cGMPs are controlled