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.Training Provided By: Biopharma Institute
Outline/Syllabus: See individual course pages for outline.
In this program, you will learn 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 course has been created for anyone who is 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 course is the perfect starting point. Our course will bring you up to speed with the world of e-record data integrity very quickly, explaining the basics of what is involved. The purpose of this course is to provide an easy launchpad to allow learners to search for more detailed information when it is needed.
Upon completion of this program, 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.
Upon completion of this program, you 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 you're developing a system from scratch or purchasing a system, requirements need to be defined. That should be obvious if you're developing software but maybe not so much if you're 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 course we will discuss software in the same manner, what is your intended use for it?
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.
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.
See the individual courses below for descriptions and outlines.
Computer System Validation (CSV) Professional Certification Program includes these 15 individual courses:
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.
- Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- 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 a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
- 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.
- 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: 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 requirements have been fulfilled.