Student Login |


Tuesday, August 09, 2022
Home » Software Validation Assurance (SVA) Professional Certification Program

Software Validation Assurance (SVA) Professional Certification Program

Certification TrainingProgram/Course ID: SVPRO
Enrollment Period: 12 months (1 year).
Average Learning Time: ~18 - 27 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 12 individual courses (see courses).
Outline/Syllabus: See individual course pages for outline.
Digital Badge: Issued upon completion.
Post-nominal Letters: SVPro™.
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: $1395.00 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 main objectives of this professional certification are to give learners a grounding in the principles of Software Validation, Computer Systems Validation and the documentation associated with a complete Software Validation Lifecycle (SDLC). There are 9 individual courses within the Software Validation Assurance (SVA) Professional Certification program. These courses are described below.

Introduction to Software Validation (Part 1 of 2): This course focuses on software validation for support systems. These are the systems used to develop, deliver, measure, maintain, or assess products such as, Document Management Systems (DMS), Manufacturing Execution Systems (MES), and control systems. The main purpose of this course is to help students establish a solid validation process.

Introduction to Software Validation (Part 2 of 2): This course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes.

The Life Cycle of a Software Validation Protocol: In many regulated environments both product software and software that could impact product quality are expected to be validated. The scope of this course is intended to focus on the development and execution of test protocols. While this approach and these techniques apply to regulated environments, they are intended to be practical enough for any environment.

Computer System Validation - The Regulated Software Life Cycle: Upon completion of this course, 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) or Quality Management System (QMS).

Computer System Validation - Basic Concepts & GAMP®5: Upon completion of this course, you will be able to understand the importance of computer system validation, 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.

Computer System Validation (CSV) Best Practices: Computer systems validation is an area of high focus by regulators. In this course, we'll discuss CSV best practices in relation to ALCOA+. As we have seen with some of the FDA Warning Letters that we've covered in previous courses in this data integrity awareness program, inspectors will check to see that the software is validated to have the proper level of control over the corresponding data consistent with ALCOA+ principles.

Computer System Validation - Risk Management: 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 course we will cover in a clear concise manner how risk applies to your CSV projects.

Validation: Implementing Compliant Systems in the Cloud: In this course, students will learn how to implement compliance systems in a cloud environment to meet FDA and European regulatory requirements. The course 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.

Computer System Validation - The Master Validation Plan (MVP): This course is 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 course. In this module we will concentrate on the Master Validation Plan (MVP) and explain how this is such an important aspect of the entire CSV lifecycle.


Software Validation Assurance (SVA) Professional Certification Program includes these 12 individual courses:

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



Individual Course w/Certificate of Completion:

Validation: Introduction to Software Validation (Part 1 of 2)

Course ID: ELM-113
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Validation: Introduction to Software Validation (Part 2 of 2)

Course ID: ELM-119
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Validation: The Life Cycle of a Software Validation Protocol

Course ID: ELM-111
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

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:

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 - 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: 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:

Data Integrity: Computer System Validation (CSV) Best Practices

Course ID: ELM-154
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.
  • 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.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:


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