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| And many more...... |
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| GOOD MANUFACTURING PRACTICES |
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Day 1 |
Day 2 |
Day 3 |
- Course Overview
- Quality philosophy
- Building & Premises
- Clean Room Concept
- Documentation I
- Quality Manual
- Site Master File
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- Documentation II
- Procedures
- SOP, Data Sheet
- Format, Guidelines
- Personnel
- Material Management
- Packaging & Labeling
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- Preliminary Statistics & In-process QC
- Self Inspection & Quality Audit
- Hygiene & Sanitation
- Validation
- Water System
- Concluding Session
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| QA CONCEPTS |
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Day 1 |
Day 2 |
Day 3 |
- Course Overview
- Quality philosophy
- Functions of QA
- Regulatory Aspects
- Good Manufacturing Practices
- Training imparted by QA
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- Documentation
- Deviation & Change Control
- Standard Operating Procedures
- Specifications & Quality Plans
- Calibration
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- Validation
- Handling External Audit
- Complaint handling
- Recall
- Compliance Reporting
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| VALIDATION & QUALIFICATION |
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Day 1 |
Day 2 |
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- Course Introduction
- Validation/Qualification Philosophy
- Validation Master Plan
- Validation Protocol/Reporting
- Process Validation
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- Qualification Master Plan
- DQ/IQ/OQ/PQ
- Facility and Utility Qualification
- Clean Room Qualification
- Cleaning Validation
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| RISK BASED APPROACH IN PHARMACEUTICAL INDUSTRY |
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Day 1 |
Day 2 |
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- Course introduction
- Risk Management Principle
- Risk Management Process
- Risk Management and Quality Management System
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- Methods of Risk Management
- Fault Tree Analysis
- Failure Mode Effect Analysis
- FTA & FMEA
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| WHO GUIDELINES |
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Day 1 |
Day 2 |
Day 3 |
- Course Overview
- Quality Assurance Philosophy
- GMP - Main principles
- GMP - Specific
- Guidelines on HVAC System
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Guidelines on:
- Validation Master Plan
- Process Validation
- Cleaning Validation Guidelines
- Analytical Method Validation
- Equipment Validation
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Guidelines on:
- Water System
- Sampling System
- Good Storage Practices
- Concluding Session
- Question & Answers
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| TRAIN-THE-TRAINER |
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Day 1 |
Day 2 |
Day 3 |
- Developing a training programme
- Presentations: Types & Means
- Presentation: Preparation & Skills
- Assessment of trainees
- Training imparted by QA
|
Training requirements from:
- QA
- QC
- Production
- HRD
- Stores
- Utility
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Demo presentation by:
- QA
- QC
- Production
- HRD
- Stores
- Utility
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| DOCUMENTATION MANAGEMENT & CONTROL |
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Day 1 |
Day 2 |
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- Course Introduction
- Documentation Philosophy
- Documentation Pyramid
- How to Write Documents
- Document Distribution Control System
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- Change Control System
- Internal Audit Documentation
- Document Review System
- Site Master File, BMR, Guidelines
- Drug/Device Master File
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| CLEAN ROOM CONCEPTS |
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Day 1 |
Day 2 |
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- Course Overview
- Clean Room Philosophy
- Contamination & Protection
- Mix-Up & Cross Contamination
- National & International Standards
- Clean Room Technology
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- Air Handling System: AHU, Filters, Exhaust.
- Design & Construction
- Monitoring
- Qualification
- Operational Aspects
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