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III. Analytical Method Development & Validation by HPLC & GC (Theory): Fee Rs.5000/- [Theory , Interview Orient Material , Certificate] – 10 Days
1. Concept of Method development
2. Method development by HPLC
3. Method development by GC
4. ICH Guidelines
5. Assay , Dissolution, Content Uniformity & Related substances Validation
6. Cleaning Validation
7. Preparation of Protocol & Report
8. Method validation by HPLC
9. Method validation by GC
10. Interview based training
II. Quality Assurance Basic Training & Documentation – Fee Rs. 4000/- [Theory, Interview Orient Material , Certificate] – 15 Days
1. Quality Assurance General Concept & Responsibility
2. Validation and Qualification
3. Preparation Maintenance and Distribution of Documents (Standard Operating Procedures, Standard Testing Procedures, General Testing Procedures , BMR-Batch Manufacturing Records and Specification)
4. Overview & Importance applications of the Following Guidelines (GMP, GLP, ICH & CFR etc.)
5. Good documentation practices & Classification of Documents
6. Drug Master Files (DMF)
7. Understanding of analytical methods, procedures and implementation in manufacturing sites from QC perspective
8. Handling of out of specifications
9. Understanding various pharmacopeia requirements.
10. Handling of Data and Audits
ANALOG LABS
Pharma & Analytical testing laboratory & training centre
3rd Floor, Plot No. 86, Near Amma mess, Oppo. Canara Bank,
Prashanthi Nagar, kukatpally y junction, HYD-500072
For Registration call: 9618252442
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