Audit

1. Audit Guidelines for Assessing Sufficient Qualified Personnel in an Analytical Testing Laboratory
2. Preparing for FDA Inspections: Tips for Pharmaceutical Companies
3. Procedure for Audit Trail Verification in Analytical Testing Laboratory For Drugs
4. Audit Trail Requirements in Pharmaceuticals
5. Difference: Annual Product Quality Review (APOR), Annual Product Review (APR) and Product Quality Review (PQR) In Pharmaceuticals
6. Annual Product Quality Review and Quality Enhancement of Pharmaceuticals
7. Self-Inspection and Quality Audits in the Pharmaceutical Industry
8. Preparation of Annual Product Review (APR)
9. Guidelines for Preparation of Site Master File (SMF)
10. Current Good Manufacturing Practices – cGMP in Pharmaceutical Industries
11. Guide to Inspections of High Purity Water Systems
12. Checklist for Internal Audit or Self Inspection Defects and Regulatory Compliance GMP Audit Check List-
13. Storage of Starting Materials
14. Checklist for Audit in HR/Admin
15. Checklist for Audit in Warehouse
16. Checklist for Audit in Regulatory Affairs
17. Checklist for Audit in Liquid Production
18. Checklist for Audit in Engineering/Maintenance
19. Checklist for USFDA Audit Preparation in Quality Control
20. USFDA Audit Points/ Observations
21. Checklist for OOS Investigation
22. Checklist for Line Clearance in Manufacturing
23. Checklist for Vendor Audits
24. Checklist for Audit in Laundry
25. GMP Audit Check List-Personnel and Premises
26. GMP Audit Check List-Water Supply System
27. GMP Audit Check List-Weighing and Dispensing
28. GMP Audit Check List-Filling and Packaging
29. GMP Audit Check List-Process Validation
30. GMP Audit Check List- Sanitation and Hygiene
31. GMP Audit Check List- Equipment
32. Audit Trail Verification for a Single Medicine Batch: A Comprehensive Guide
33. Audit Procedure and Steps for Pharmaceutical Raw Material Tracking
34. Procedure, Steps, and Checklist for Supplier Verification Audit in the Pharmaceutical Industry
35. Regulatory Expectations from Cleaning Validation
36. Importance of Data Integrity in Pharmaceuticals
37. 5 Steps of FDA Approvals
38. Requirements of FDA for Training in Pharmaceuticals
39. Planning and Procedure followed During Regulatory Audits
40. Top 5 Tips for a FDA Inspection
41. How Pharmaceutical Companies Can Prevent Drug Recalls
42. 7 Steps for Monitoring Compliance in Pharmaceuticals Difference between FDA 483 and Warning Letters
43. Trends in GMP Violations in Pharmaceuticals
44. Case Studies: Troubleshooting Purified Water System Failures Data Integrity – A Major Problem in
45. Pharmaceuticals
46. Top 10 Tips for FDA Inspection Preparation
47. Determination of Data Integrity Compliance in Pharmaceuticals
48. 6 Ways to Reduce Human Errors in Pharmaceuticals
49. Key Preposes of Change Control in Pharmaceuticals How to respond to an FDA 483 observations?
50. A Brief Description of the Entire Audit Process in Pharmaceuticals
51. Planning and Execution of Internal Audits in Pharmaceuticals
52. GMP Violations at Indian Facilities
53. Preparing for FDA Inspections: Best Practices for Compliance
54. Are You Ready for an FDA Inspection?
55. Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals
56. The Impact of Training Management on Quality Issues
57. Tips for Effective Internal Audit System
58. What you should Inspect when Conducting Self-inspection in Pharmaceuticals
59. Allergen Control Plan for Pharmaceuticals
60. FDA 483 Observations Related to Cleaning in Pharmaceuticals
61. Improving Quality Through Supplier Audits in Pharmaceuticals
62. Typical Microbiology Concems in a FDA Inspection
63. How FDA Inspections are Conducted in Manufacturing Facilities
64. The Value of FDA 483s and Warning Letters
65. Data Integrity: How Important is it for Pharmaceutical Regulatory Bodies?
66. Data Falsification in Pharmaceutical Manufacturing: A Serious Crime
67. Periodic Review and Compliance in the Pharmaceutical Industry
68. Self Inspection and Its Implementation in Pharmaceuticals
69. Fishbone Tool of Investigation in Pharmaceuticals
70. What does Inspector Look for during FDA Inspection?
71. FDA’s Top Data Integrity Issues Found During Inspections How to Prepare for a FDA Inspection
72. 5 Most Common 483s in FDA Inspections
73. Why Data Integrity is More Important Than Ever? Critical Mistakes during Root Cause Investigation Major
74. Audit Findings about Equipment and Instruments
75. 4 Tips to Reduce 483 Observations
76. Preparation for GMP Audit in Pharmaceuticals
77. Analytical Balances Drift and Its Importance
78. FDA Forms Generally Used in Pharmaceutical Inspection
79. FDA Form 483 and Warning Letters