Enrollment Period: 12 months (1 year).
Average Learning Time: ~9 - 14 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Courses: Program includes 6 individual courses (see courses).
Outline/Syllabus: See individual course pages for outline.
Digital Badge: Issued upon completion.
Post-nominal Letters: DIPro™.
Catalog: Data Integrity.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $995.00 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.
Whether you are already familiar with data integrity or not, it's important to know that data integrity is an essential component of product quality and safety to health authorities and to companies like yours. By ensuring the integrity of data and records, not only do you help to protect the patients, but you also contribute to safeguarding your company, as well as the employees themselves. In addition, you are helping to ensure the quality of the product released by the company.
This program focuses on providing an understanding of the principles and practices of data integrity, as well as the associated regulations and guidelines affecting these practices. Upon completion of this program, students will be able to explain the following concepts related to data integrity awareness and health authorities, health authority auditing, FDA and MHRA data integrity expectations, observations by health authority inspectors and recent examples of violations found in FDA warning letters. Students will be able to explain the following concepts related to data integrity and ALCOA+, compliant data characteristics, regulatory expectations for data integrity and data control, fundamentals of ALCOA and ALCOA+ (the key building blocks of data integrity) and ALCOA+ for electronic data. Students will be able to explain the following concepts related to good documentation practices (GDP), key reasons for maintaining GDP, GDP the FDA, Eudralex, and WHO, documents within the scope of GDP, general rules of GDP, GDP and ALCOA+ and GDP best practices. Computer systems validation (CSV) is an area of high focus by regulators. In this program, 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. Completion of this course, students will be able to explain the following concepts related to data governance. Quality risk management and electronic data systems, 21 CFR Part 11 guidelines on electronic records, data governance basics and data integrity best practices.
Review the individual courses included in this program (see below) for program descriptions and outlines.
Data Integrity Professional Certification Program includes these 6 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.