Conference Description:

This two day workshop on 'Good Laboratory Practices' is an important element of GMP in pharmaceutical manufacturing and a regulatory compliance requirement. Accurate, consistent and reliable analytical results are crucial for assessing the quality of drug substances, drug products and other pharmaceutical materials. Very high level of knowledge & discipline is required in the QC laboratory to achieve this objective. During the past several years Integrity of laboratory data in Indian pharmaceutical companies, specifically electronic records and data are in the focus by international regulatory agencies.

LEARNING OBJECTIVES:

GLP Regulations
21 CFR part 58
ISO 17025:2017
SOPs and Best Practices
Instrument Calibration & Qualification
Control of Standards
OOS, OOT and LIRs
Impurity Profiling of Drugs
Analytical Method Validation
GLP Inspection Observations
Data Integrity
Quality Metrics .... and More




DEPARTMENTS:

- Quality Control
- Quality Assurance & Testing
- Research and Development
- Laboratory
- Manufacturing
- Production
- Regulatory Compliance
- Validation
- Preclinical Development
- Documentation
- Training Departments