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Best Practices in Biopharma Manufacturing Best Practices in Clinical Research Biotechnology & Genetics Major Therapeutic Areas Pharmaceutical and Healthcare Codes of Conduct
BROWSE BY DISCIPLINE
Anatomy and Physiology Bioinformatics BioPharma Cardiovascular System Central Nervous System (Neurology) Diabetes Gastrointestinal System Good Clinical Practice (GCP) Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP) Immunology Infection IS/IT Series Marketing & Selling Medical Devices Musculoskeletal System Oncology Ophthalmology Pain Psychiatric Disorders Quality Control (QC) Respiratory System Urology Validation
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| | 21 CFR Part 11 Duration: 1 Hour and 45 Minutes
Certificate of Completion:
Provided immediately upon successful completion. |
Ordering For Multiple Users (training 10 - 200 users, annually) see GeneEd's On Demand Training |
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 21 CFR Part 11
Description: In August, 1997, the FDA gave the Industry the set of rules for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records. This course discusses why Title 21 of Code of Federal Regulations Part 11, or "21 CFR Part 11" was developed, the role Part 11 plays in the adherence to other sections of 21 CFR, and explores the general concepts of security in a Part 11 compliant system.
Similar or Related Courses & Suites:
SUITE: Drug Development Pipeline: Essential Regulations (Seven Course Suite)
 GLP 0: Good Laboratory Practice, Overview
21 CFR Part 11
GMP 0: Good Manufacturing Practice, Overview
GCP 1: Good Clinical Practice, Level 1
GCP 2: Good Clinical Practice, Level 2
Drug Safety: Adverse Event Reporting
GXP: Industry Overview
About GeneEd's Online Training:
- GeneEd Online Training Courses are high-quality, Flash driven, learning
tools including voiceovers and dynamically engaging graphic animations.
- This GeneEd Online Training Course is accessible for 90 days via the Internet,
and a Certificate of Completion is accessible once requirements are filled.
- GeneEd Online Training Courses have an instructional design which encourages
knowledge retention and long term recollection.
- GeneEd Online Training Courses are developed for healthcare professionals
(nurses and doctors), clinical researchers, and for patient education.
- To access your GeneEd Online Training Course, your username, password and
login URL will be provided to you shortly after ordering.
Accreditation: GeneEd designates this educational activity for a maximum of 1.75 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.
GeneEd, Inc. is accredited by the Institute for Medical Quality/California Medical Association (IMQ/CMA) to provide continuing medical education for physicians. GeneEd, Inc. takes responsibility for the content, quality and scientific integrity of this CME activity.
In addition to physicians, GeneEd Online Training Courses are also applicable for nurses (RNs), doctors (MD and PhDs), clinical research associates (CRAs or monitors), clinical research coordinators (CRCs), investigators, researchers, bioprocess / biomanufacturing workers, QA/QC managers, other healthcare professionals and for patient education.
| 21 CFR Part 11
OUTLINE
INTRODUCTION
1. Course Information
2. Interface Tour
3. Course Overview
OVERVIEW
4. Objectives
5. The Need for Part 11
6. Electronic Records
7. Developer vs. User Requirements
SECURITY
8. Objectives
9. General Concepts
10. Passwords
11. Open and Closed Systems
12. Data Management
AUDIT TRAILS
13. Objectives
14. General Concepts
15. Electronic Signatures
TRAINING
16. Objectives
17. Training
18. Supporting Procedural Infrastructure
PART 11 SYSTEMS
19. Objectives
20. Validation
21. Security Issues
22. Compliance
CONCLUSION
23. Summary | | 21 CFR Part 11
OBJECTIVES
Students completing this course, 21 CFR Part 11, should be able to:
Describe how the need for regulations on electronic records led to the creation of Part 11.
Identify the Part 11 regulations and their scope.
Explain how Part 11 relates to other sections of 21 CFR. Describe why Part 11 compliance makes both legal and business sense.
Explain the FDA trickle-down theory of regulation. Identify the main areas of security concern and the implications of threats in these areas.
Explain how passwords are used to protect data and the importance of NOT sharing passwords. |
BROWSE COURSES BY CATALOG:
| Best Practices in Biopharma Manufacturing | Best Practices in Clinical Research | Biotechnology & Genetics | Major Therapeutic Areas | Pharmaceutical and Healthcare Codes of Conduct |
BROWSE OTHER COURSES BY DISCIPLINE:
| Anatomy and Physiology | Bioinformatics | BioPharma | Cardiovascular System | Central Nervous System (Neurology) | Diabetes | Gastrointestinal System | Good Clinical Practice (GCP) | Good Laboratory Practice (GLP) | Good Manufacturing Practice (GMP) | Immunology | Infection | IS/IT Series | Marketing & Selling | Medical Devices | Musculoskeletal System | Oncology | Ophthalmology | Pain | Psychiatric Disorders | Quality Control (QC) | Respiratory System | Urology | Validation |
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