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Home » Computer System Validation (CSV) Professional Certification Program

Computer System Validation (CSV) Professional Certification Program

Certification Training
 
Rated 4.07/5
28 reviews
Program/Course ID: CSVPRO
Enrollment Period: 12 months (1 year).
Average Learning Time: ~23 - 34 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 15 individual courses (see courses).
Outline/Syllabus: See individual course pages for outline.
Digital Badge: Issued upon completion.
Post-nominal Letters: CSVPro™.
Catalog: Computer System Validation (CSV).
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $1495.00 USD  

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

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Outline/Syllabus: See individual course pages for outline.
Description:

The Computer System Validation (CSV) Professional Certification Program will describe how to implement compliance systems in a cloud environment to meet FDA and European regulatory requirements. We will outline from a technical perspective the cloud and the different service models available. The different deployment models and their considerations for implementation in a GMP environment. The compliance challenges related to security, data integrity, visibility and control, and the risk mitigation strategies to reduce or eliminate risk associated to security, data integrity and control.

This program has been created for those interested in learning more about managing and ensuring integrity of e-records within a regulated environment. If you would like to expand your knowledge of e-record integrity but find it difficult to move forward in the process, this program is the perfect starting point. The training will bring you up to speed with the world of e-record data integrity very quickly by first explaining the basics of what is involved. The purpose of this section is to provide an easy launchpad to allow learners to search for more detailed information when it is needed.

Upon completion of this program, students will be able to understand the importance of computer system validation (CSV), the regulations and standards behind CSV, recommendations and best practices for CSV, understand the role of GAMP®5 (GAMP5), and the competence required for a validation team.

Additionally, students will understand the waterfall and agile approach to development, design, validation and verification, the difference between commercial and in-house software, support processes, change management, and the pharmaceutical quality system (PQS), formerly called quality management system (QMS).

Whether a company is developing a system from scratch or purchasing a system, requirements need to be defined. That should be obvious when developing software, but maybe not so much if purchasing software. Consider buying a pre-built house or condominium. You're not going to take the first one you walk up to just because it's available. You're going to, at least at some level, establish your requirements. In this program we will discuss software in the same manner, and assist students with determining what their intended use is for the software.

Risk, risk-based approach, risk-based decisions, and on and on. Clearly, expectations are to consider risk. But what does that mean? What does taking a "risk-based approach" to validation mean? In essence, the degree to which a computerized system is validated, and the level of controls implemented is based on risk. Are the risks associated with the application sufficiently controlled to minimize the effects? In this program we will cover in a clear concise manner how risk applies to the CSV projects.

There is a section of this program geared specifically towards those individuals that will perform computer system validation. A certain understanding of software is important to be proficient in CSV, but we've tried to provide sufficient information for folks with non-software backgrounds to jump into the CSV fray. Those in management positions with responsibility for validating computer systems should also find great benefit in this program. In additional sections, we will concentrate on the Master Validation Plan (MVP) and explain how this is such an important aspect of the entire CSV lifecycle.

See the individual courses below for descriptions and outlines.


Computer System Validation (CSV) Professional Certification Program includes these 15 individual courses:

(Click on course links below to see outline/syllabus)



Individual Course w/Certificate of Completion:

Validation: Implementing Compliant Systems in the Cloud

Course ID: ELM-118
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment

Course ID: ELM-125
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Computer System Validation - Basic Concepts & GAMP®5

Course ID: ELM-132
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Computer System Validation - The Regulated Software Life Cycle

Course ID: ELM-133
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Computer System Validation - Requirements: The Basis for Validation

Course ID: ELM-134
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Computer System Validation - Risk Management

Course ID: ELM-162
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Computer System Validation - The Master Validation Plan (MVP)

Course ID: ELM-163
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Application of the Validation Plan

Course ID: ELM-164
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Validation Testing - Part 1

Course ID: ELM-165A
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Validation Testing - Part 2

Course ID: ELM-165B
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Maintaining the Validated State

Course ID: ELM-166A
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Supplier Provided Software

Course ID: ELM-166B
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Special Topics

Course ID: ELM-167
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Periodic Review Strategies - Part 1

Course ID: ELM-149A
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

CSV: Periodic Review Strategies - Part 2

Course ID: ELM-149B
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Additional Information:

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately 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 following enrollment into any program or course. Students may attempt the final assessments any number of times, as needed, to achieve a passing score.

Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format.

Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display the accomplishment.

Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline.

Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world.

Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate.

Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical industries.

Employee / Corporate Training: 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 and large-scale training requests.


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.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • 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.