Introduction to Life Sciences

The Life Sciences industry is one of the most regulated industries in the world and is subject to regulation by different government agencies. Pharmaceutical, biotechnology, clinical research, medical device and healthcare companies are required to meet relevant GxP requirements for their business operations, which involve well-trained personnel.

The “Introduction to Life Sciences Training” introduces the concepts and requirements necessary for compliance with relevant GxP requirements and standards for Life Sciences industries. It also provides the participants with comprehensive understanding of good documentation practices, as they pertain to all GxP records and provide real-world examples of good and bad documentation practices. Finally the course also gives insight to all pertinent regulations and industry guidelines.

CTG can provide training to your employees to ensure they are appropriately trained and have adequate skills, knowledge and awareness to work in the Life Sciences industry.

Upcoming

07-05-2019


Introduction to Life Sciences

Course Objectives

The goal of this course is to create awareness about the fundamental principles of compliance with pertinent regulations and industry guidelines in the Life Sciences industry.

Each participant will have gained knowledge about following topics:

  • Define GxP (GMP, GLP, GDP, and GCP)
  • Discuss the history and purpose of the GxP standards
  • Identify the regulatory authorities in the US, Europe, Canada, and Japan
  • Describe the importance of the GxP standards in protecting public health
  • Quickly access important documentation and links to FDA and EMEA regulations
  • Describe a Quality Management System
  • Describe good documentation practices and the role that it plays to production and process controls
  • Correct errors and omissions in data entry
  • Sign, date and label data and records
  • Identify relevant regulations (and guidelines) governing use of computerized systems in GxP environments
  • Describe the safeguards required for use of GxP critical systems
  • Quickly access regulations and guidelines.

Typical Audience

The “Introduction to Life Sciences Training” course is designed for Business, QA and IT personnel that are new to the regulated environment. It is important, and is also a regulatory requirement, that all individuals working within the Life Sciences industry receive GxP related training and are capable of performing their assigned duties.

Course Prerequisites

A basic knowledge of English is required.

Course Delivery

The training is given in a classroom format and is structured to offer flexibility and to cater for participant needs and circumstances by considering prior learning and level of staff experience.

Courses can be given in English or in Dutch. Course material is in English.

Course Venue

The course duration is 1 day.

This course can be given at the client’s site or at CTG.

Course Administration

Pricing

€ 750 per person
€ 695 per person on second subscription for the same company
€ 600 per person on third (or more) subscription for the same company

All prices are VAT excluded; course material, lunch and beverages included.

Cancellation

  • By Participant: If a subscribed course participant is replaced by another participant or if the public course is postponed to a later date, no cancellation costs apply. A participant or a group that fails to attend, or that cancels a course without at least 15 working days written notice prior to the course start, is liable for the full subscription cost.
  • By CTG: CTG reserves the right to cancel a course at any time.

Course Logistics

This classroom course starts promptly at 9 am and is scheduled until 5 pm. All courses are organised at the CTG premises in Diegem (Belgium).

All courses can be given at the client’s site and are available for groups as well. Please contact us if you wish further information.

Course Outlines


Introduction to Life Sciences

This module introduces the concepts and requirements necessary for compliance with relevant GxP requirements and standards for life sciences industries.

Good Documentation in Life Sciences

This module provides the participants with comprehensive understanding of Good documentation Practices, as they pertain to all GxP records and provide real-world examples of good and bad documentation practices. This module can also be used for retraining or a preventive action in response to a documentation deviation.

Overview of Pertinent Regulations & Guidelines

This module provides insight to all pertinent regulations and industry guidelines.

Meet our trainers

CTG's trainers are experts in their domain and bring the course content based on their experience. Meet some of our trainers below.
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Trainings Done
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Hours of Training
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Contact

Europe

CTG Belgium NV

Woluwelaan 140A
1831 DIEGEM
Belgium
phone: +32 2 720 51 70
fax: +32 2 725 09 20

North-America

Buffalo, New York

800 Delaware Ave

Buffalo, NY 14209-2094

phone: +1 716 882 8000

fax: +1 716 887 7464