Compliance Trainings, Hyderabad
2018-02-22
On completion of this course, the participants shall be well versed with the global Quality control laboratory compliance requirements, inspection trends as well as strategies and best practices for maintaining regulatory compliant GLP standards to ensure consistent Quality Attributes and bench marking Quality Metrics in the Pharmaceutical Quality Control Laboratories.
Practical examples and interactive exercises will be dispersed into and between the presentations. Here the experts will discuss case studies and create a platform platform to resolve QC laboratories' day-to-day issues like Documentations, Investigations (OOS, OOT, OOC) and validation compliance checklists to ensure you are well prepared for your next audit.
LEARNING OBJECTIVES :
FDA, EU, WHO, PIC/S, India GLP Regulations 21 CFR part 11 and EU Annex 11 FDA 483s and Warning Letters Observations Validation Master Plan SOPs and Best Practices Equipment Calibration and Qualification Systems Validation Analytical Method Validation OOS, OOT and OOC Laboratory Data integrity FDA Audit Preparation CASE STUDIES .... and
WHO MUST ATTEND
DEPARTMENTS:
- Quality Control - Quality Assurance - Research and Development - Manufacturing - Regulatory Compliance - Validation - Production - Technology Transfer - Laboratory - Documentation - Training departments
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