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Friday, November 16, 2018
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IS/IT: Introduction to Compliance (ISIT1)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-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

BioPharma Institute LogoTraining Program: IS/IT: Introduction to Compliance
Training 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.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, 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 training: 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
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The IS/IT: Introduction to Compliance course is found in the following professional certification program(s):


Compliance in Electronic Signatures & Records Professional Certification Program: The Compliance in Electronic Signatures & Records Professional Certification Program covers two areas of training, including and introduction to compliance and compliance with specific respect to regulation 21 … Learn more

IS/IT Compliance and Qualifications Professional Certification Program: This IS/IT Compliance and Qualifications Professional Certification Program introduces the student to the applicable regulations, how they affect IT, and describes what constitutes applicable regulations. The c … Learn more


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.


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.

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