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TRAINING ON PHARMACEUTICAL QUALITY SYSTEMS

TRAINING ON PHARMACEUTICAL QUALITY SYSTEMS

There are 6 Quality Systems in Pharmaceutical Industry. At sGMP-PS, we are providing the very important training related to individual functionality in quality system. We will be making the entrant confident enough for begining the desired Pharmaceutical industry journey.

Quality Assurance

* Good Documentation Practices
* cGMP Practices
* Line Clearance
* Contamination Controls
* Sampling Techniques (SFG and FG)
* Control Samples
* Hold Study
* Process Validation and Sampling
* Cleaning Validation and Sampling
* Batch Documentation
* Investigations
* QMS – Change Management Deviation Management, CAPA Management

Quality Control

* Sampling of Raw Materials and Packaging Materials
* Sampling Plans
* Good Laboratory Practices
* Out-of-Specification Investigation
* Good Chromatographic Practices
* Instrumentation skills for HPLC, UV, IR, KF and Dissolution
* Handling of Reference Standards and Working Standards
* Data Integrity
* Audit Trails
* Stability Study

Production (with Packaging and Labelling)

* cGMP Practices
* Equipment Cleaning (Level 1 or Level 2)
* Log Books and recording
* Line Clearance
* Status Labelling
* Contamination Control
* Area Sanitisation
* Batch documentation
* Toolings and Ancillary Equipment
* Electronic Data Review
* Audit Trail
* Control on Printed Packaging Materials
* Types of Packaging
* Various systems challenges (compression and Packaging)
* Yield Calculation (Actual Yield and Reconciliation Yield)

Warehouse (Materials)

* Materials receipt
* Documentation
* Materials Storage
* Dispensing of Materials
* FIFO – FEFO
* Approved Vendor List
* Handling Printed Packaging Materials
* FP storage and distribution

Engineering (Facility and Equipment)

* Equipment Qualification
* Area Qualification
* Temperature Mapping
* Preventive Maintenance
* Breakdown Maintenance
* Calibrations
* Air Handling System
* Purified Water System
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