Good Manufacturing Practice in the Laboratory
Training
In Reading
Description
-
Type
Training
-
Level
Intermediate
-
Location
Reading
-
Duration
1 Day
-
Start date
Different dates available
This course is an adaptation of our standard 1-day GMP course, designed specifically for laboratory staff who have unique, additional requirements laid out in GMP both in the European and USA regulations and guidance documents.
The pharmaceutical quality control laboratory serves one of the most important functions in the manufacturing environment. Many of the GMP regulations and guidances apply to control laboratories but in particular Chapter 6 (QC and Good Control Laboratory Practice) of the EU Guide to GMP. The course also covers the role of documentation, pharmacopoeias, laboratory reference standards, calibration, calculations and results. The final session of the course brings all this together by a session on preparing for regulatory inspection.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Laboratory Practice
- Quality Training
- Regulations
- Quality
- GMP
- Pharmaceutical manufacturing
- Pharmacopoeias
- Auditing
- Documentation
- Calibration
Teachers and trainers (1)
Andy Martin
Tutor
Course programme
Course Overview
This course is an adaptation of our standard 1-day GMP course, designed specifically for laboratory staff who have unique, additional requirements laid out in GMP both in the European and USA regulations and guidance documents.
The pharmaceutical quality control laboratory serves one of the most important functions in the manufacturing environment. Many of the GMP regulations and guidances apply to control laboratories but in particular Chapter 6 (QC and Good Control Laboratory Practice) of the EU
Guide to GMP. The course also covers the role of documentation, pharmacopoeias, laboratory reference standards, calibration, calculations and results. The final session of the course brings all this together by a session on preparing for regulatory inspection.
Suitability
This course is suitable for all laboratory staff working in an environment covered by the requirements of GMP and GCLP (Good Control Laboratory Practice).
Learning Outcomes
At the end of the course you will:
- Have knowledge of the expectations of the regulators in operating control laboratories
- Understand the unique role of testing laboratories in the pharmaceutical environment
- Be able to prepare for regulatory or customer audits
Additional information
Good Manufacturing Practice in the Laboratory