Method of Training: Online / Self-paced eLearning.Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $199.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: 21 CFR Part 820 Subpart M - Records
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. Records are what we create to provide the evidence that we are following our procedures; therefore, they are extremely critical. It is important to remember that the records we generate must be admissible in court and therefore good documentation practices (GDP) are also important. Record alterations are considered a deliberate misrepresentation of facts. When an alteration is discovered during litigation it seriously undermines the ability to defend the claim of regulation compliance.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
21 CFR Part 820 Subpart M - Records course is included in the following Professional Certification Programs:
ISO, ICH and the FDA
Definition of a medical device
Class I, II and III
History of 21 CFR Part 820
21 CFR 820 Timeline
1906 - The Jungle
1937 - Massengil Company
1957 - Thalidomide
1971 - Dalcon Corporation
1990 - FDA device recall report
A regulatory evolution
Records -Subpart M
Good Documentation Practices
Signatures and Initials - Legally Binding
Signatures and Initials - Verification
Signatures and Initials - Signature Cards
Signatures and Initials - Asian Countries
Date and Time
Date and Time - Backdating
Handling Errors - Blank Spaces
Significant Figures and Rounding of Numbers
Record Retention - DMR & DHR
Quality System Record
Complaints - Uniform & Timely
Complaints - MDR
Complaints - Reporting
This training program has been developed to train employees with Intermediate Knowledge of 33 CFR Part 820 (Medical Devices).
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.