ISO 14971: Basic Framework for Risk Management
Enrollment Period: 6 months.
Average Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online, Asynchronous, Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Medical Device Regulatory Affairs.
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 14971: Basic Framework for Risk Management
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
The learning objectives for this module are to set the foundation regarding the basics of risk management. We will point out that there are multiple tools that can facilitate risk management. We will provide a useful approach to Risk Management planning and discuss organization of the risk file. The specific sections in this module include, Risk Management Framework, Toolbox, [4.4] Risk Plan and [4.5] Risk Management File.
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.
- Learning Objectives
- Who Will Benefit from This Training?
- Materials Used
- Program Overview
- Course Introduction
- Course Overview
- Learning Objectives
- Risk Estimation: Severity
- Risk Estimation: Probability
- How to Score the Risk
- Risk Acceptability
- Fault Tree Analysis
- Ishikawa or Fishbone Diagram
Risk Management Plan
- Assignment of Responsibilities and Authorities: Part 1
- Assignment of Responsibilities and Authorities: Part 2
- Risk Management Activities
- Requirements for Review of Risk Management Activities
- Criteria for Risk Acceptability
- Method to Evaluate the Overall Residual Risk
- Verification Activities
- Activities Related to Collection and Review of Relevant Production and Post-Production Information
- Relationship to Other Plans
Risk Management File
- Risk File
- Family of Devices
This training program has been developed to train employees with Intermediate Knowledge of 1SO 14971:2019 (Medical Devices).
ISO 14971: Basic Framework for Risk Management is included in the following professional certification programs:
ISO 14971:2019 for ProfessionalsCourse ID: ISOPRO
Price: $995.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
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.