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Home » Validation: Operational and Performance Qualification (OQ/PQ)

Validation: Operational and Performance Qualification (OQ/PQ) (VAL04)

Certification Training
 
Rated 4.44/5
9 reviews
Method of Training: Online / Self-paced eLearning.
Credits: 1 CPD Credits.
Duration: ~1 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: Operational and Performance Qualification (OQ/PQ)
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 program offers an introduction to operational qualification (OQ) and performance qualification (PQ). Having undergone Installation Qualification (IQ), before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This program describes OQ and PQ 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.

Course training objectives include: To illustrate a compilation of an OQ and PQ report, to demonstrate the preparation, approval, and execution of an OQ/PQ protocol, to offer a summary of the key differences between PQ and OQ, to identify and explain the responsibilities of PQ and OQ, to identify and explain the activities to be carried out during PQ and OQ, and to identify and explain the scope of PQ and OQ.

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.

Operational Qualification
This session explains how to identify equipment, systems and services to which Operational Qualification (OQ) applies. It identifies typical responsibilities of company staff and vendors for OQ. It specifies prerequisites for OQ and describes steps in the OQ process. It identifies tests required of equipment, systems and services during OQ. The learner is shown how to develop, review and execute protocols that specify the tests required, and to write OQ reports.

Performance Qualification
This session specifies the purpose of Performance Qualification (PQ), and identifies typical responsibilities of company staff for PQ. It specifies the steps of PQ and describes the activities to be carried out, including environmental microbial monitoring where necessary. The learner is shown how to prepare, review and execute PQ protocols and write PQ 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 OQ and PQ
  • Explain the scope of OQ and PQ
  • Identify typical responsibilities of company staff for OQ and PQ
  • Specify the steps of OQ and PQ and describe activities to be carried out
  • Prepare, approve and execute OQ and PQ protocols
  • Write OQ and PQ reports

The Validation: Operational and Performance Qualification (OQ/PQ) 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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