IS/IT: Introduction to Compliance (ISIT1)
 | Duration: 2 hours, Online (the average time to complete the training program, including final assessments). Credits Hours: 2Self-paced Training: 24/7 access to course. Enrollment Period: 3 months. Catalog: IT/IS for BioPharma Companies. Demonstration: Try one of our FREE courses. Certificate: View sample certificate. PRICE: USD $195.00 
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 Training Program: IS/IT: Introduction to ComplianceTraining Provided By: BioPharma Institute Website: https://www.biopharmainstitute.com Availability: Immediately available upon ordering. Description: Online training with immediate access upon enrollment.  The IT/IS: Introduction to Compliance Program introduces the student to the applicable regulations which affect IT. These IT services are heavily relied on by companies today. This is why it is so important for the corporate IT department to comply with the strict regulations. The final assessment for this course contains multiple-choice questions and is taken online (users can take the test an unlimited number of times until they pass). Once the course requirements have all been satisfied a Certificate of Completion will be issued. Students taking the IT/IS Compliance and Qualifications Professional Certification Program should note that this Introduction to Compliance Course is found within that program. Benefits of Getting Certified at BioPharma Institute Effective, efficient, and convenient training solutions are available to healthcare, biotechnology, and pharmaceutical industry personnel through the high-quality e-learning courses furnished by the BioPharma Institute. Through the years, we have put together a collection of books, recorded seminars, online courses, and other training implements that we use to instruct courses involving the various job aspects and functions within these healthcare, biotech, and pharma industries. We are a trusted Institute that has proudly provided online training solutions to corporations both abroad and within the United States. With our proven techniques the BioPharma Institute can assist companies in the education of their employees, thereby making it possible for them to improve their overall quality of service and excel in their careers. Have Questions? Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information. Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements. The IS/IT: Introduction to Compliance course is found in the following professional certification program(s):
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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. | |
Online Training Program Benefits:
- Immediate access to training: Instructions, username, password and receipt of payment 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 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.
