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Home » ISO 14155:2020 Medical Device Standard

ISO 14155:2020 Medical Device Standard

Certification Training
 
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Program/Course ID: CP008a
Enrollment Period: 6 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: 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 Standard
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
Biopharma Institute ReviewsDesigning 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:


  • 1. Overview of the ISO Standard (Sections 1, 2, and 3)
  • a. International Organization for Standardization Background & What are ISO Standards
  • b. ISO 14155:2020 Background
  • c. ISO 14155:2020 - Table of Contents
  • d. Know the Standard Activity and Answer
  • e. ISO 14155:2020 and GCP
  • f. When is ISO 14155:2020 Enforceable?
  • g. CIP vs. Protocol
  • h. Important Terminology - Normative vs. Informative
  • i. General Changes to ISO 14155:2020

  • 2. Clinical Investigation Planning (Section 6)
  • a. Clinical Investigation Plan (CIP)
  • b. Annex A
  • c. Clinical Procedure Risks and Their Disclosure
  • d. ISO 14155:2020: Risk Assessment (Annex H)
  • e. Risk Management for Sponsors
  • f. Risk Management and the CIP Knowledge Check
  • g. Investigator's Brochure (links to Annex B)
  • h. Monitoring Plan Overview
  • i. Monitoring Plan Elements
  • j. Case Report Forms (CRFs) (links to Annex C)
  • k. Investigation Site Selection
  • l. Know the Standard Activity and Answer

  • 3. Responsibilities of the Sponsor (Section 9)
  • a. Site Selection and Training Requirements
  • b. Monitoring: Clinical Quality Management
  • c. Investigation Site Initiation (7.2)
  • d. Monitoring: CIP and Investigators
  • e. CRO, Vendor, Site Oversight
  • f. Routine Monitoring Visits
  • g. Monitoring: Documentation (Informed Consent, eCRF, AE or ADE)
  • h. Preparation of Documents
  • i. Certified Copies and Validated Systems
  • j. Know the Standard Activity and Answer

  • 4. Responsibilities of the Investigator (Section 5 and 10)
  • a. Responsibilities of the Investigator Intro
  • b. Investigator Qualifications
  • c. Investigation Site (7.2, 9.2.1, 7.6, &10.3)
  • d. Communication with Ethics Committee (5.6 and 10.4)
  • e. Ethics Requirements
  • f. Informed Consent (10.5 & 5.8)
  • g. Informed Consent Requirements
  • h. Responsibilities of the Investigator
  • i. Investigator Compliance with the CIP
  • j. Know the Standard Activity and Answer

  • 5. Clinical Investigation Conduct and Safety (Section 7)
  • a. Section 7: Clinical Investigation Conduct
  • b. Know the Standard Activity and Answer
  • c. Safety Requirements
  • d. ISO 14155:2020: Adverse Events & Device Deficiencies (7.4)
  • e. Adverse Events and Device Deficiencies Definitions
  • f. ISO 14155:2020: Device Deficiencies
  • g. Risk Assessment (Section 7.4.4)
  • h. Adverse Event Characterization (AE, SAE, ADE, SADE, USADE, DD)
  • i. Annex F
  • j. ISO 14155:2020 Annex E Essential Documents

  • 6. Suspension, Termination, and Close-out of Clinical Investigation (Section 8)
  • a. Routine Closeout
  • b. Termination/Suspension/Close-out, Including Report, Risk Assessment & Conclusions
  • c. Document Retention (links to Annex E)
  • d. Audits (Annex J)
  • e. Clinical Investigation Report (Annex D)

  • 7. Scenario

  • 8. 10 Question Post Assessment

Objectives:


  • Describe the ISO 14155:2020 standard requirements for Medical Device GCP.
  • Recognize how the ISO 14155:2020 standard applies to activities related to site monitoring and investigator responsibilities.
  • Apply the ISO 14155:2020 standard to study activities.

Audience:
All clinical research personnel

Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, 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 with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • 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.


Have Questions? Contact Us:

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