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Equip Val: Introduction to Risk Based Equipment Qualification

Certification TrainingProgram/Course ID: ELM-121
Enrollment Period: 3 months.
Allocated Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Validation for BioPharma Companies.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

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: 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 within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


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

Objectives:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Equipment Qualification.

Equip Val: Introduction to Risk Based Equipment Qualification is Included in the Following Professional Certification Program(s):



 Training Program For Professionals: 
Equipment Qualification for Professionals
Course ID: EQPRO
Price: $680.00 (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 which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: 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 (1-100 students) and large-scale (100+ students) training requests.


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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