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Wednesday, October 20, 2021
Home » Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data Signatures

Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data Signatures

Certification TrainingProgram/Course ID: CP016a
Enrollment Period: 3 months.
Average Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Credit Hours: 2 credits.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Training Program: Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data Signatures
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThis course covers Overview of 21 CFR Part 54 Financial Disclosure and Part 11 Electronic Data Signatures. This course's main topics are financial disclosure, electronic records, and electronic signatures under FDA's 21 CFR Part 54 and Part 11. These topics are applicable to drug, device, and biologic studies. Required by Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. Part 11 describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


Outline:


  • Case Studies
  • Knowledge Checks
  • Post-Assessment
  • Certificate of completion

Objectives:


  • Apply critical thinking techniques for effective implementation of 21 CFR Part 54 and Part 11.
  • Reflect on how 21 CFR Part 54 and Part 11 affect your role in clinical research.
  • Discuss challenges and opportunities in implementing 21 CFR Part 54 and Part 11.


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.


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