1. Quality Mangement
1.1. Equipment Qualification
1.2. Failure Investigation
1.3. Validation of Visual Checking Inspectors
1.4. Data Integrity
1.5. Acceptable Quality Level
1.6. Corrective Action & Preventive Action
1.7. Process Validation
1.8. Change Control
1.9. Handling Market Complaints
1.10. Preparation of Master Formula Record
1.11. Incident Reporting & Investigation
1.12. Hand Wash Procedure
1.13. Standard Operating Procedures
1.14. Line Clearance in Manufacturing Area
1.15. Samling & Release of in Process Samples
1.16. Sampling of Finished Products
1.17. Discipline in Manufacturing Area
1.18. Quality Assurance
1.19. Quality Compliance
2. Sales & Marketing
2.1. Sales and Marketing functions
2.2. Sales Process
2.3. Negotiation Techniques
2.4. Customer Relationship Management
2.5. Marketing Techniques
2.6. Customer Service in Sales
2.7. Terminologies in Sales and Marketing
2.8. Booking & Cancellation Policy
2.9. Credit Policy
2.10. Discount Policy
3. Accounts & Finance
3.1. Accounts Organizational Structure
3.2. Accounting Metrics
3.3. Salary Processing
3.4. Various Governing Acts
3.5. Provident Fund
3.6. Employee State Insurance
3.7. Intellectual Property Rights
3.8. Asset Management
3.9. Tax Management
3.10. Responsibilities of Finance Manager
3.11. Annual Budgeting
3.12. Bank Payment
3.13. Bill Books Management
3.14. Cheques Management
3.15. Cash Management
3.16. Inventory Management
4. Information Technology
4.1. Data Integrity
4.1.1. Corrective & Preventive Action as per Risk Assessment
4.1.2. Action on generation of false data or modification of data
4.1.3. Prevent unauthorized access to systems
4.2. Maintain Periodic Backup
4.3. Realtime data synchronization
5. Supply Chain Department
5.1. Insurance Management
5.2. Guidelines for Warehouse Facility Assessment
5.3. Procedure for Inbound Operations
5.4. Procedure for Warehouse Operations
5.5. Procedure for Outbound Operations
5.6. Warehouse Safety and Security
5.7. Types of Stocks and Stock Rooms
5.8. Inventory Auditing and Reporting
5.9. Warehouse Compliance Management
5.10. Inventory Storage Guidelines
5.11. Acceptable Dunnage and Packing Practices
5.12. Internal, Vendor and Statutory Audits of Warehouses
5.13. Guidelines for Frisking of Employees and Visitors
5.14. Vehicle Gate Entry & Exit Procedures
5.15. Housekeeping Guidelines
5.16. Discrepancy and Deviation Management
5.17. Partner Relationship Management
6. Research & Development
6.1. Research Governance
6.2. Regulatory Requirements
6.3. Trust Policies & Procedures
6.3.1. gSOP01: SOP on SOPs
6.3.1.1. Writing Research Protocols
6.3.1.2. Research Applications
6.3.1.3. TMF
6.3.1.4. CRF & Data Management
6.3.1.5. Role of CI, Pharmacy, and R&D
6.3.1.6. Vendor Assessment
6.3.1.7. Risk Assessment
6.3.1.8. Statistics
6.3.1.9. Consent
6.3.1.10. Patient Information
6.3.1.11. Sponsor Oversight
6.3.1.12. Monitoring
6.3.1.13. Source Data
6.3.1.14. Initiation (Sponsored)
6.3.1.15. Research Staff Training
6.3.2. gSOP19: QMS
6.3.2.1. Amendments
6.3.2.2. Guidance Document on setting up hosted trials
6.3.2.3. Guidance Document on NIHR Commercial Costing
6.3.2.4. Sponsorship Policy
6.3.2.5. Contract Review Guidance
6.3.2.6. Serious Breaches
6.3.2.6.1. Sponsored
6.3.2.6.2. Hosted
6.3.2.7. Trial Closure
6.3.2.7.1. Sponsored
6.3.2.7.2. Hosted
6.3.2.8. End of Trial Reporting