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Home » Validation: Commissioning and Installation Qualification (IQ)

Validation: Commissioning and Installation Qualification (IQ) (VAL03)

Certification Training
 
Rated 3.86/5
7 reviews
Method of Training: Online / Self-paced eLearning.
Credits: 1.5 CPD Credits.
Duration: ~1.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingDemonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Validation: Commissioning and Installation Qualification (IQ)
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 Reviews

This online program offers an introduction to the international principles and regulations behind commissioning and installation qualification (IQ).

Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


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.


COURSE OUTLINE:


Introduction
A brief introduction to the validation project that provides a case study on validation.

Basics of commissioning and Installation Qualification
This session defines commissioning and Installation Qualification (IQ), summarizes their purposes, and identifies differences between them. It outlines the progression of commissioning and IQ in a validation project, along with the roles of Factory Acceptance Testing and Site Acceptance Testing. It describes how responsibilities for commissioning and IQ are assigned in a typical company. It identifies vendor equipment documentation that may be included in specifications, as well as the contents of commissioning reports.

Impact assessment
This session explains the roles of impact assessment and criticality assessment. It discusses how to draw system boundaries and use impact assessment to determine the scope of qualification work required.

Installation Qualification
This session describes how to decide which components of each system require qualification and which need only be commissioned. It identifies systems/services that support the production line, and gives examples of tests applied to them as part of qualification. It identifies important parts of IQ protocols, and gives examples of qualification criteria specified in protocol test sheets. Finally, it outlines requirements for calibration of devices, instruments and systems.

IQ documentation
This session specifies important characteristics of IQ protocols, and outlines how to execute the protocols. It identifies documents that typically need to be completed during qualification. It specifies contents of an IQ report, and identifies requirements for the sign-off of protocols and reports.

Assessment
The assessment tests the learner's assimilation of the module's content.

COURSE OBJECTIVES:


Who will benefit from this module?
Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of validation, as set out in this module. In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

Learning objectives
  • Define commissioning and Installation Qualification activities and scope
  • Explain the purposes of, and differences between, commissioning and qualification
  • Determine qualification requirements based on an impact assessment
  • Prepare and execute IQ protocols
  • Describe requirements for the content and approval of IQ reports

The Validation: Commissioning and Installation Qualification (IQ) Course is Included in the Following Professional Certification Programs:


Quality Control in the Laboratory Professional Certification Program: The Quality Control in the Laboratory Professional Certification Program is an online program offered by Biopharma Institute. The program provides training on the current standards governing lab professionals a ... Learn more

Pharmaceutical Validation Management Professional Certification Program: This professional certification program includes an introduction to the principles behind the international regulations assuring effective validation and qualification procedures, commonly referred to as Good V ... Learn more

Online Training: The Benefits of 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 requirements.
  • 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.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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