Overview
This programme is designed for Analysts, Laboratory Supervisors and Managers working in QC laboratories in the pharmaceutical or related industries. The programme will assist them to apply Good Laboratory Practice (GLP) principles in practical laboratory situations.
Participants will develop skills in GLP and laboratory management, method validation, data management, basic statistical analysis techniques commonly used in data evaluation and gain an understanding of industry regulatory requirements.
Key Subject Areas
- Laboratory Quality Management Systems and Quality Manuals
- International requirements for GLP in regulated laboratories
- How to set up and conduct a laboratory audit
- Test method validation, method transfer and acceptance criteria
- Documentation and data management
- Investigation of out of specification conditions
- Sampling plans and procedures
- Basic statistics for laboratory data evaluation
Course Outcomes
On completion of the course, participants will be able to:
- Implement the GLP requirements for documentation and records
- Design the scope of a Laboratory Quality Manual
- Explain the parameters for method validation and acceptance criteria
- Apply a simple Design of Experiments (DOE) for method validation
- Apply basic statistics to typical laboratory data
- Explain the regulatory requirements for investigating out of specification conditions
- Identify statistical outliers in a data set
- Interpret sampling plans and select sample sizes
Duration
3 consecutive days
Course Format
This course is conducted in house. It has been developed as 7 modules, each of which can be customised to the client's environment.
The course is designed to be intensive and interactive to achieve maximum learning experience. It is conducted in a workshop setting with theory lectures interspersed with practical exercises and workshops. Emphasis is on active participation so numbers are restricted to no more than 12.
Customisation
This course may be customised by Pharma Systems or the client and presented in-house. Customisation is by way of using in house data and addressing in house issues.
Presenters
SeerPharma (UK) will lead the course and facilitate the group activities.
Course Materials
Delegates will be given a manual containing copies of the slides, accompanying notes and other relevant information.
Following the successful completion of the course, each delegate will be presented with a certificate.
To request further information on this course or to reserve a place (with no obligation) please contact us using the details below:
PO Box 3255,
Littlehampton,
BN17 9AD
Tel: 01903 730 622
e-mail: debra.stanfield@seerpharma.co.uk
