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Tuesday, August 09, 2022
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Validation: Introduction to Validation

Certification Training
 
Rated 4.22/5
18 reviews
Program/Course ID: VAL01
Enrollment Period: 6 months.
Average Learning Time: ~90 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1.5 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: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $195.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: Validation: Introduction to Validation
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
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.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


Outline:


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.

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

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 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

Validation: Introduction to Validation is included in the following professional certification programs:



Professional Certification Program:

Pharmaceutical Validation Management Professional Certification Program

Course ID: VAL00S1
Price: $1299.00 (USD) | Learn more

Training Program For Professionals:

Computer System Validation for Professionals

Course ID: VAL00S2
Price: $695.00 (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 validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: 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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.