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Thursday, September 23, 2021
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Data Integrity Professional Certification Program

Certification TrainingProgram/Course ID: DATAINT
Enrollment Period: 6 months.
Allocated 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: 6 courses included (see below).
Digital Badge: Issued upon completion.
Catalog: Data Integrity.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $995.00

Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.

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

Description:

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 Courses:



 Individual Course w/Certificate of Completion: 
Data Integrity: An Introduction to Data Integrity
Course ID: ELM-148
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Data Integrity: Health Authority Expectations
Course ID: ELM-151
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Data Integrity: ALCOA and ALCOA+
Course ID: ELM-152
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Data Integrity: Good Documentation Practices
Course ID: ELM-153
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Data Integrity: CSV Best Practices
Course ID: ELM-154
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Data Integrity: Data Governance
Course ID: ELM-155
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Additional Details:

Certification Requirements: Students must view the entire program and successfully pass online, multiple-choice final assessments for each course within a 180 day/6-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Program enrollees can 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 certification ID code. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to validate the training achieved. Digital badges can be displayed on social networking sites, such as LinkedIn.

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

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-scale (1-100 students) and large-scale (100+ students) training requests.


Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • 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 course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on 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.
  • Purchase orders (POs) accepted: If 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.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.


Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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