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Home » Equip Val: Introduction to Risk Based Equipment Qualification

Equip Val: Introduction to Risk Based Equipment Qualification (ELM-121)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: 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.

Biopharma Institute LogoTraining Program: Equip Val: Introduction to Risk Based Equipment Qualification
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThis course describes how to assess the risks to product quality in the event of a functional failure of equipment used in a pharmaceutical cGMP environment. The risk based qualification assessment describes the qualification steps (Risk Assessment, Design, Installation, Operational and Performance Qualification etc.) required to qualify the equipment in order mitigate that risk.
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: Introduction to Risk Based Equipment Qualification course is included in the following Professional Certification Programs:



Equipment Qualification for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Course Introduction
Course Overview
Course Objectives

Module 1
The Starting Line

Terms Explained
Benefits of Equipment Qualification
US Regulatory Compliance
European Regulations
ICH Q9

Module 2
Equipment Qualification Planning

Equipment Qualification Process
Qualification Planning
Master Validation Plans
Qualification Need Assessment
Risk Classification
Direct Impact
Indirect Impact
No Impact
Impact Based Qualification Activities
Direct Impact Documentation
Indirect Impact Documentation
Master Validation Plan Listing

Module 3
Risk Tools

User Requirement Specification (URS)
Risk Assessment
What is Risk?
What is Risk Management?
Risk Management Tools
Risk Management Tools Cont'd
HACCP - Hazard Analysis and Critical Control Points
HAZOP - Hazard Operability Analysis
FTA - Fault Tree Analysis
PHA - Preliminary Hazard Analysis
Quality Risk Management Tool Selection
Failure Mode Effect Analysis (FMEA)
So What is Expected During Regulatory Inspections?
Step 1: Risk Detection/Identification
Step 2 is Risk Analysis
Step 3 is Risk Evaluation
Risk Evaluation Methods - Quantitative Method
Risk Evaluation Methods - Qualitative Method
The Hybrid Method
Severity & Probability
Risk Control
Risk Assessment Table
Risk Communication
Risk Review

Module 4
Qualification Phases

FAT (Factory Acceptance Testing)
SAT (Site Acceptance Testing)
Equipment Design Qualification (DQ)
DQ Review Documents
Installation Qualification (IQ)
Documents to Analyze During IQ Review
Pre-conditions for IQ Execution
Equipment Operational Qualification (OQ)
OQ and Commissioning
Pre-Conditions for OQ Execution:
Equipment Performance Qualification (PQ)
Pre-conditions for PQ execution:
Requalification
Change Control

Conclusion


Final Exam


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

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.

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