IS/IT: Introduction to Compliance (ISIT1)
 | Method of Training: Online / Self-paced eLearning. Credit Hours: 1 credits.Duration: ~1 hour(s). Self-paced Training: 24/7 access to course. Enrollment Period: 3 months. Demonstration: Try one of our FREE courses. Certificate: View sample certificate. THIS COURSE IS CURRENTLY NOT AVAILABLE. Contact the Biopharma Institute for more information. |
COURSE OUTLINE:INTRODUCTION TO REGULATIONS 1. Introduction 2. First Class Pharmaceuticals 3. What Is Compliance? 4. Regulations Overview 5. Disasters in Reporting 6. How Regulations Came About 7. The IT Perspective 8. Headlines 9. Working in a Regulated Industry 10. How Regulations Affect IT 11. What Is IT Compliance? 12. Ramifications 13. Scope of the Audit 14. Computerized Systems 15. Review REGULATIONS IN DETAIL 16. Regulations in Detail 17. Introduction 18. Who Are the Regulators? 19. Policies and Procedures 20. Regulations 21. What Is GxP? 22. What Is GMP? 23. GMP in Different Countries 24. US Regulations 25. What Is 21 CFR Part 11? 26. HIPAA 27. SOX 28. Review I 29. Regulatory Guidelines I 30. Regulatory Guidelines II 31. Best Practice Guidelines 1 32. Best Practice Guidelines II 33. Review MEETING LEGAL OBLIGATIONS 34. Introduction 35. Outcomes of Non-compliance 36. Meeting Regulations 37. IT Compliance Policies and Procedures 38. Example 39. Global Policies and Procedures 40. Activity 41. Review MANAGING COMPLIANCE REGIONALLY 42. Introduction 43. Issues Managing Compliance 44. Company Policies and Procedures 45. Issues Managing Multi-Site Systems 46. System Management Model 47. Review CONCLUSION 48. Summary 49. GLOSSARY/RESOURCES | COURSE OBJECTIVES:Recognize the regulations that affect the life sciences industry. Recognize the impact these relations have on IT. Identify the common IT features of these regulations. State the role of regulations and guidelines. Recognize the compliance issues to be managed in multi-site companies. | |
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