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: Validation for BioPharma Companies.
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: Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified Risks and acceptance of residual risks. Upon completion of this course you will understand the overall concept of Quality Risk Management (QRM), where does risk come from, the potential areas for Quality Risk Management application, the regulatory requirements and the various risk management tools
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.
Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2 course is included in the following Professional Certification Programs:
Who should take this course?
FMEA - A General Overview
The advantages of a FMEA
So what is a FMEA?
Endorsed by the FDA
How did FMEA start?
ICH Q9: Quality Risk Management
Application of FMEA in the pharmaceutical industry
What can FMEA do for you?
When to conduct FMEA?
Getting Started with FMEA
The FMEA process
Risk analysis - Probability of Occurrence (O)
Risk analysis - Severity (S)
Risk analysis - Likelihood of Detection (D)
Risk evaluation - Quantitative Method
Risk evaluation - Qualitative Method
The hybrid method
Risk - Should we quantify or qualify?
FMEA - Table format
FMEA - Granulation suite qualitative approach example
Example of a risk assessment management plan
Example of a FMEA table for a granulation suite - Quantitative approach
Who Carries Out a FMEA?
The FMEA team
Qualification of the team members
Limitations of FMEA
What are the limitations of a FMEA process?
Subjective and tedious
Single failure mode
Outputs and inputs
Only an assessment tool
Only as good as the team
Examination of external influences
Examination of human error
Reasons for ineffective FMEAs
Tips for successful implementation of a FMEA
Primary FMEA facilitation skills
This training program has been developed to train employees with Intermediate Knowledge of Equipment Qualification.
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.