1. Objectives of the training, expected outcomes and review of the agenda.
2.Overview and Principles GLP
3 • GLP guidelines
4• Basic Laws & Regulation governing QC/QA Laboratories.
5.• Principles of GLP
6 • Application of the Principles of GLP
7• Guidance to preparation of GLP inspection report
7• Laboratory organization & Personnel in GLP
8• Guidelines on Laboratory facilities
9.• Laboratory equipment’s
9 • Instrumentation Validation
10• Materials
11 • Reagents
12 • Receipts
12 • Chain of Custody
Guidelines for Reporting & Documenting results
13 • General guidelines
14 • Sample integrity requirements
15• Analytical report
15 • Uncertainty measurements
16• Content of analytical report
17 • Analytical results
18 • QC/QA
19 • Confidentiality
20.Standard Operating Procedures (SOPs)
21• Introduction to SOPs and types of SOPs
22 • Development & Review of SOPS
13 • Application of SOP
Practical’s session
14. • Analysis of GAPs and overlaps in existing SOPs
15 • Dos and Don’ts in SOP writing
16• Optimization of internal capability of SOPS
17• Checklist & Document control
17• Tracking & Archrival
2.Overview and Principles GLP
3 • GLP guidelines
4• Basic Laws & Regulation governing QC/QA Laboratories.
5.• Principles of GLP
6 • Application of the Principles of GLP
7• Guidance to preparation of GLP inspection report
7• Laboratory organization & Personnel in GLP
8• Guidelines on Laboratory facilities
9.• Laboratory equipment’s
9 • Instrumentation Validation
10• Materials
11 • Reagents
12 • Receipts
12 • Chain of Custody
Guidelines for Reporting & Documenting results
13 • General guidelines
14 • Sample integrity requirements
15• Analytical report
15 • Uncertainty measurements
16• Content of analytical report
17 • Analytical results
18 • QC/QA
19 • Confidentiality
20.Standard Operating Procedures (SOPs)
21• Introduction to SOPs and types of SOPs
22 • Development & Review of SOPS
13 • Application of SOP
Practical’s session
14. • Analysis of GAPs and overlaps in existing SOPs
15 • Dos and Don’ts in SOP writing
16• Optimization of internal capability of SOPS
17• Checklist & Document control
17• Tracking & Archrival
