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.
INTRODUCTION TO REGULATIONS
2. First Class Pharmaceuticals
3. What Is Compliance?
4. Regulations Overview
5. Disasters in Reporting
6. How Regulations Came About
7. The IT Perspective
9. Working in a Regulated Industry
10. How Regulations Affect IT
11. What Is IT Compliance?
13. Scope of the Audit
14. Computerized Systems
REGULATIONS IN DETAIL
16. Regulations in Detail
18. Who Are the Regulators?
19. Policies and Procedures
21. What Is GxP?
22. What Is GMP?
23. GMP in Different Countries
24. US Regulations
25. What Is 21 CFR Part 11?
28. Review I
29. Regulatory Guidelines I
30. Regulatory Guidelines II
31. Best Practice Guidelines 1
32. Best Practice Guidelines II
MEETING LEGAL OBLIGATIONS
35. Outcomes of Non-compliance
36. Meeting Regulations
37. IT Compliance Policies and Procedures
39. Global Policies and Procedures
MANAGING COMPLIANCE REGIONALLY
43. Issues Managing Compliance
44. Company Policies and Procedures
45. Issues Managing Multi-Site Systems
46. System Management Model
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.
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.