Student Login |


Sunday, May 16, 2021
Home » Validation: Computer System Validation - Part I (Planning)

Validation: Computer System Validation - Part I (Planning) (VAL09)

Certification Training
 
Rated 4.43/5
7 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: Computer System Validation - Part I (Planning)
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 computer systems validation. Course objectives include the following: to offer an understanding the computer systems life-cycle and the fundamentals of computer systems validation. In the medicines and healthcare products industries, computerized systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This module describes the planning of such validation. It follows the work of a pharmaceutical company's team as they validate the dispensary control system for a new production line.

Once all course requirements have been satisfied, a certificate of completion is immediately available in PDF format. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade. Following a brief introduction, topics covered in this course include: Validation plan and strategy, planning phase, and a conclusion that summarizes the previously listed topics.

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
This session defines computer system validation and specifies its benefits. It identifies, in general terms, which systems need to be validated. It identifies sources of guidance from industry bodies and regulatory authorities, and it discusses the importance of protection of data integrity.

The planning phase
This session identifies the phases of the computer systems lifecycle, and outlines the activities that are performed in the planning phase. It specifies the purposes of a User Requirements Specification and a traceability matrix.

Validation strategy and plan
This session specifies criteria for regulatory assessment. It outlines FDA requirements on electronic records and electronic signatures. It describes in detail how to assess software suppliers and their products. It sets out principles of risk management. Finally, it outlines the contents of a validation plan, including change management.

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 computerized system validation, as set out in this module. In particular, the module provides essential learning for engineering, information and communication technology, production, and quality management personnel in the pharmaceutical industry.

Learning objectives
  • Define computer systems validation
  • Outline criteria for selecting systems to be validated and for initial estimation of the degree of validation required
  • Access important guidance documents by industry bodies and regulatory authorities
  • Identify the phases of the computer systems lifecycle and describe the activities that are performed in each phase
  • Describe considerations influencing validation strategy
  • Assess software suppliers and their products
  • Outline the contents of a validation plan

The Validation: Computer System Validation - Part I (Planning) Course is Included in the Following Professional Certification Programs:


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:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
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):