Student Login |

Sunday, May 16, 2021
Home » Validation: Introduction to Validation

Validation: Introduction to Validation (VAL01)

Certification Training
Rated 4.43/5
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: Introduction to Validation
Training Provided By: Biopharma Institute

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

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. This program provides an introduction to validation and to the regulations and guidance that apply to it. It describes 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.


Module outline
Regulations, guidance and definitions
This session emphasizes the need to comply with regulatory requirements and guidance on validation, identifying important regulatory authorities and international collaborations. It identifies the phases of equipment qualification, describes the purpose of process validation in relation to process control, and defines important terms relevant to validation.

Development of risk-based approach to validation
This session explains why, in the absence of process validation, testing of samples is inadequate to provide assurance of product quality, safety and effectiveness. It outlines the historical development of validation requirements and identifies some current trends. It emphasizes the importance of a risk-based approach to validation and describes factors for assessing risk.

What to validate?
This session explains how to develop the scope of a validation plan, distinguishing critical and non-critical equipment, services and utilities. It specifies criteria for validation of computerized systems and for selection of process steps for validation. Finally, it discusses the importance of validation of cleaning and laboratory test methods.

Stages of validation
This session describes the 'V model' approach to equipment qualification. It outlines the contents of a User Requirements Specification document, and explains the role of Factory Acceptance Testing and Site Acceptance Testing. It distinguishes commissioning and qualification, and describes the phases of qualification and validation. Finally, it identifies standard operating procedures that are created during qualification and validation.

Documentation and change control
This session identifies important documents created during a validation project, and outlines relationships among protocols and reports. It describes how to record deviations and failures, and their resolution. Finally, it discusses requirements for change control of validation documentation.

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


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 terms relating to validation
  • Access sources of regulations and guidance on validation in the medicines and healthcare products industries
  • Specify the phases of equipment qualification and process validation and describe the goals of each phase
  • Use risk assessment to determine the scope of a validation project
  • Describe the relationships between specifications and protocols in the V model of validation
  • Discuss criteria for User Requirements Specification, Factory Acceptance Testing, and Site Acceptance Testing
  • Identify important documents created and used during a validation project, and specify their relationships
  • Describe procedures for change control of validation documentation

The Validation: Introduction to Validation 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

Computer System Validation Professional Certification Program: This online professional certification program includes an introduction to the international principles and regulations behind effective validation and qualification, an introduction to the international princi ... 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.

Information Request / Suggest a Course Form:

Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):