Software Validation Assurance (SVA) Professional Certification Program
Enrollment Period: 12 months.
Average Learning Time: ~18 - 27 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, asynchronous, 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 outlines.
Digital Badge: Issued upon completion.
Post-nominal Letters: SVPro™.
Catalog: Computer System Validation (CSV).
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
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.Training Provided By: Biopharma Institute
Outline/Syllabus: See individual course pages for outline.
The objectives of this professional certification are to give learners a strong understanding for the principles of Software Validation Assurance (SVA), overview of Computer Systems Validation (CSV) and the documentation associated with a complete Software Validation Lifecycle (SVLC).
There are 12 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, students 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 CSV projects.
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.
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.
Maintaining the Validated State: Changes can be sneaky little things. There are many ways a system can move out of a validated state. Changes directly to the software are the obvious ones that could impact the validated state and procedures need to be defined as to how the changes are controlled and the system re-validated following the change (and of course, before deployment). In this course we will guide students on how to maintain the validated states for computer systems.
Special Topics: This course has been designed to discuss all of the various special topics that exist around computer system validation (CSV) and how to approach them from a solid foundation. In this course we will cover Data and Data Integrity, SaaS Software, Backup and Restore, Spreadsheets, Data Migration, Managed IT Services, Infrastructure (Hardware), Using Contractors, Critical Thinking and Electronic Record and Electronic Signatures.
Supplier Provided Software: Software is either developed internally or procured from a software developer. There could be the case that the company may have an internal development team that 'sells' development services to other divisions, and in this case they can be considered a vendor. Software suppliers can range from commercial software providers (e.g., Microsoft or Oracle) to "garage shop" software developers (hint: probably best to avoid garage shop providers regardless of cost!). In this course we will cover what students need to look out for when dealing with software vendors in a regulated environment.
Software Validation Assurance (SVA) Professional Certification Program includes these 12 individual courses:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment 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 or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.
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 accomplishments.
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 cater to both small and large-scale training requests.
Benefits of Training with Biopharma Institute
|Immediate access to courses:||Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.|
|Self-paced, asynchronous eLearning:||24/7 access to all course materials and assessments for 12 months.|
|Open enrollment:||No prior course prerequisites or work experience required.|
|Expertise:||Courses developed by subject matter experts (SMEs) in the area being taught.|
|Current and validated:||Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.|
|Optimized for learning:||Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.|
|Secure and safe access:||Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.|
|Flexible final assessments:||Multiple-choice questions can be taken repeatedly until a passing score is achieved.|
|Direct access to certificates:||Certificate of completion is instantly available once requirements have been fulfilled.|
|Verification of training:||Certificates verifiable online with digital badges issued for all professional certification programs.|
|Training manager access:||A proprietary portal offers access to download enrollment reports, training records, account balance, and more.|
|SCORM-compliant courses:||Courses can be delivered directly to most corporate Learning Management Systems (LMS).|
|Purchase orders (POs):||POs are accepted from all companies. Request an invoice when starting the procurement process.|
|Reimbursement:||Some employers may reimburse their employees for training expenses. Check your company's policy.|
|Financial assistance:||Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.|
|Career advancement:||Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.|