ISO 14155:2020 Medical Device Standard
 | Enrollment Period: 6 months. Average Learning Time: ~45 minutes. Additional Resources: Supplemental materials/activities. Method of Training: Online, Asynchronous, Self-paced eLearning. Accessibility: 24/7 access to all program materials.Credit Hours: 2 credits. Catalog: Clinical Trials Management and Monitoring. Demonstration: Five (5) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $199.00 USD |
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: ISO 14155:2020 Medical Device StandardTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  Designing and conducting a clinical trial should be done with Good
Clinical Practice (GCP) and quality in mind to ensure the reliability
of trial results as well as to follow requirements of regulatory
authorities. Organizations usually understand the necessity of
following ICH E6(R2) to ensure GCP; however, there is frequently
a gap in training internal teams, contractors, CROs, and sites on
ISO 14155:2020 GCP for medical devices. Following the standard
is a key part of building globally recognized GCP into the full life
cycle of the medical device clinical trial and can complement the
current GCP training.
This course covers an overview of the ISO 14155:2020 standard for medical device GCP. Use with a copy of your organization's standard or purchase a copy from www.iso.org.
Content includes an Overview of the Standard, Clinical Investigation Planning, Sponsor Responsibilities, Responsibilities of the Investigator, Clinical Investigation Conduct, and Suspension, Termination, and Close-out of Clinical Investigation.Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements. Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance. Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion. Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. |
Outline:
| Objectives:
Audience: All clinical research personnel | |
Benefits of Training with Biopharma Institute
- Immediate access to courses: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced, asynchronous eLearning: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: Courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: Courses are current with respect to regulations, procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection, including firewall protection and daily scans for malware, to deliver optimal level of security and performance.
- Flexible final assessments: Assessments 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 requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- SCORM-compliant courses: Courses can be delivered directly from most corporate Learning Management Systems (LMS).
- Purchase orders (POs): POs are accepted from all companies. You must request an invoice to start the procurement process.
- Reimbursement: Some employers may reimburse their employees for training expenses. Check your company's education reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. Alternatively, purchasing individual courses one at a time is also an option.
- Career advancement: Professional certifications help demonstrate interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer taking points for the interview, and practical knowledge for performing the work.
