Conferences and Courses for the analytical Laboratory / GMP in analytics
Highly qualified staff and executives are required for the activities in pharmaceutical laboratories. Not only the use of various methods like HPLC, GC, and NIR etc. have to be trained but also the GMP-compliant implementation in pharmaceutical quality control. Chapter 6 of the EU GMP Guide Part I defines essential provisions for quality control. The text states: „Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product.“
EU authorities and the FDA too monitor more than just manufacturing processes. They pay special attention to pharmaceutical quality control. Calibration and qualification of analytical instruments, reference standards, GMP-compliant documentation, retain samples, stability programme, validation of computerised systems and training are among the most important areas.
Furthermore, the role of the head of pharmaceutical quality control is clearly defined. Educational and appropriate qualifications as well as regular further training must be evidenced.
We regularly organises conferences and courses on pharmaceutical quality control. Here is an overview of the most frequent topics offered:
- Integrating Analytical Equipment Qualification and Computerised System Validation
- Quality of Pharmaceutical Packaging Systems
- Quality Control of Raw Materials
- Validation of Analytical Test Procedures
- Out-of-Specification Results
- FDA Compliance in Analytical Laboratories
- Reference Standards
- Setting Specifications
- Stability Testing for Drug Substances and Drug Products
Read more here about the Microbiological Laboratory Manager Certification Programme.