The life science 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 health care companies are required to meet relevant GxP requirements for their business operations which involves well-trained personnel.
Personnel working in regulated organizations should be skilled in computerized system validation activities to ensure these organizations are in compliance with pertinent regulatory requirements. CTG can provide training to your employees to ensure they are appropriately trained and have adequate skills and experience to perform their assigned duties.
This course is directed towards understanding the testing phase of computer system validation and will include reflection of regulatory expectations for testing and best practices using Microfocus ALM (Quality Center) in a regulated environment.
Microfocus ALM (Quality Center) is a test management tool that covers the principal test activities of a test process. Microfocus ALM (Quality Center) offers software quality assurance, including requirements management, test management and business process testing for IT and application environments.
The goal of this course is to provide an understanding of the use of Microfocus ALM (Quality Center) in a regulated enviroment.
The Microfocus ALM in a Regulated Environment course is designed for Quality Center administrators, Quality Center project managers, Quality Assurance leads and other Quality Center users responsible for managing projects in a regulated environment. It is important, and is also a regulatory requirement, that all individuals working within the life science industry receive GxP training and are capable of performing their assigned duties.
A basic knowledge of English is required.
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.
The course duration is 1 day.
This course can be given at the client’s site or at CTG.
Pricing
€ 910 per person
€ 850 per person on second subscription for the same company
€ 750 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
These 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 site and are available for groups as well. Please contact us if you wish further information.
The standard language of each course is English.
* Prices subject to VAT
- Releases
- Requirements
- Test Plan & Test Lab
- Defects
- Analysis
CTG Belgium NV
Culliganlaan 1D
1831 DIEGEM
Belgium
phone: +32 2 720 51 70
fax: +32 2 725 09 20
Buffalo,New York
300 Corporate Parkway
Suite 214N
Amherst, NY 14226
phone: +1 716 882 8000
fax: +1 716 887 7464