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Regulatory

  1. How to Write a Validation Master Plan?
  2. 5 Steps of FDA Approvals
  3. Planning and Procedure followed During Regulatory Audits
  4. 7 Steps for Monitoring Compliance in Pharmaceuticals
  5. New Drug Application (NDA)
  6. Case Studies: Troubleshooting Purified Water System Failures Regulatory Requirements and Guidelines for
  7. Cleaning Validation
  8. Common Challenges in Pharmaceutical Manufacturing and How to Overcome Them A Brief Description of the
  9. Entire Audit Process in Pharmaceuticals
  10. New FDA Update on Glycerin, Propylene Glycol, Maltitol Solution and other Glycols
  11. Preparing for FDA Inspections: Best Practices for Compliance
  12. How Gowning Practices Provide Clues to cGMP Compliance in Pharmaceuticals
  13. Investigational New Drug (IND) Application
  14. Good Distribution Practices for Pharmaceutical Products
  15. Keys to Executing a Successful Technology Transfer in Pharmaceuticals
  16. Planning and Designing a Pharmaceutical Manufacturing Facility
  17. The Value of FDA 483s and Warning Letters
  18. How to Know the Generic Equivalents for Branded Medicines?
  19. FDA Forms Generally Used in Pharmaceutical Inspection
  20. FDA Form 483 and Warning Letters
  21. Current Good Manufacturing Practices – cGMP in Pharmaceutical Industries
  22. Regulatory Requirements for Market Complaints
  23. Code of Federal Regulations (CFR)
  24. Generic Pharmaceutical Drugs
  25. Process Analytical Technology (PAT) in Pharmaceuticals
  26. Checklist for Audit in Regulatory Affairs
  27. SOP for Dossier
  28. Good Clinical Practice (GCP)
  29. Technology Transfer Guidelines for Pharmaceuticals
  30. Responsibility of Regulatory Affairs Professionals
  31. Introduction to Platform Technology
  32. Scale Up, Post Approval Changes (SUPAC guidelines)
  33. Pilot Plant Scale-up Considerations for Solids, Liquid orals, Semi solids and Relevant Documentation
  34. Institutional Review Board (IRB)/Institutional Ethics Committee (IEC)
  35. Trial Documents in Clinical Research
  36. Investigational Medicinal Product Dossier (IMPD)
  37. Requirement of Alarm System in Critical Equipments
  38. Less than 1 CFU/Plate in ISO 5 Class – How is it Possible? Common Technical Document (CTD) for Dossiers
  39. Role of Regulatory Affairs in Pharmaceuticals
  40. Abbreviated New Drug Application (ANDA)
  41. ICH Guidelines for Pharmaceuticals
  42. Elemental Impurity Testing of Pharmaceutical Formulations
  43. Drug Master File and Types of DMF
  44. 21 CFR and Its Recommendations
  45. Risk of TSE and BSE in Pharmaceutical Products
  46. FDA’s Data Integrity Issues in Indian Facilities
  47. SOP for Product Registration
  48. Separate Manufacturing Facility is Required for Manufacturing of Penicillin and Non-penicillin Products
  49. Regulatory Affairs
  50. cGMP Regulations for Finished Pharmaceuticals and Medical Devices
  51. International Health Regulatory Bodies
  52. SOP for Quality Risk Management
  53. Pharmaceutical Administration and Regulations in Japan
  54. WHO Newsletter
  55. Drug Information Update- FDA Approves Rituxan to Treat Two Rare Disorders
  56. FDA’s New Process Validation Guidance
  57. Pharmaceutical Bioavailability and Bioequivalence
  58. ISO: International Organization for Standardization in Pharmaceuticals
  59. Different Phases of Clinical Trials
  60. Drugs & Cosmetics Act 1940
  61. MCC Guidelines – South Africa
  62. Indian Pharmacopoeia Updates (IP)
  63. Medsafe Guidelines – New Zealand
  64. Pharmaceuticals and Medical Devices Agency (PDMA) – Japan
  65. MHRA Guidelines
  66. Schedule M
  67. Therapeutic Goods Administration (TGA) Guidelines – Australia
  68. USFDA Guidelines for Pharmaceuticals
  69. GCC Guidelines
  70. PANDRH Guidelines
  71. European (EU) Guidelines
  72. PIC/S Guidelines for GMP in Pharmaceuticals
  73. IPEQ – The International Pharmaceutical Excipients Council
  74. WHO Guidelines for Pharmaceuticals