Courses for Analytical Chemists
On-site courses provide a cost-effective means of delivering the training
that allows you to get the best out of your staff and equipment. Documented
training is essential for compliance with GMP. Training sessions and workshops
are stimulating and meet the continuing professional development needs of
your staff.
Suggested timings are included, but these can be varied to best meet your
needs.
General GMP
The principles and essentials of GMP 45 minutes
GMP in the Analytical Lab
A number of modules can be provided to cover the topics listed below. Half
day
- Brief introduction to GMP in the analytical lab
- The laboratory and instruments: Qualification, calibration and maintenance
- Staff training: Procedures and records
- Procedures in the analytical lab
- Documentation in the analytical lab
- FDA 21 CFR part 11 compliance
- Reference standards
- Quality Control testing
- Out of Specification Results and repeat testing
General Analytical Modules
- Routine analysis in the GMP lab (on a case-by-case basis for common
analytical techniques. To include, for example, HPLC system suitability testing
with reference to pharmacopoeial requirements) 45 minutes
- Validation of analytical methods 45 minutes overview or half-day detailed
- HPLC method development and optimisation 45 minutes overview to one day detailed
- GC method development 45 minutes overview or half-day detailed
- Troubleshooting HPLC 45 minutes
- Preparative HPLC 45 minutes
- Headspace GC 45 minutes
Technology Transfer
- Planning and executing analytical method transfer in a GMP environment
45 minutes overview or half-day detailed
Specialised Analytical Modules
- General chiral analysis strategies 45 minutes
- Chiral analysis by HPLC 45 minutes overview to one day detailed
- Chiral analysis by GC 45 minutes overview to half day detailed
- Polymorphic analysis 45 minutes overview to half day detailed
Workshops / laboratory visit
Depending on your requirements, workshop activities can be included, which
are stimulating and instructive. Some companies also find it useful if I visit
their analytical lab and comment on existing procedures.
Flexibility
Courses can be moulded to fulfil your particular requirements, taking into
account the training wants of your individuals and the needs of your business.