|Program/Course ID: GMP11|
Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Credit Hours: 2 credits.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $199.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: cGMP: Data Integrity
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
This course introduces you to the concept of Data Integrity; why it's important, how failures can occur and what can be done to protect it.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format 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 directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
- What is Data Integrity (DI)?
- Reviews and assessment
- Data integrity is not new
- Data integrity as part of FDA, EU and PIC/S GMPs
- GMPs for electronic records and computerised systems
- Regulators' perspectives
- Industry guidance
Risk management and controls
- Raw data and metadata
- Manual and electronic data
- What if the data are unreliable?
- Understanding risk to data integrity
- Good Documentation Practices
- Logical design
- Scenario 1 (digital reading on a pH meter)
- Scenario 2 (Operator is completing a logbook)
- Scenario 3 (Analyst calculates and records assay results in their workbook)
- Scenario 4 (automated chromatography instruments)
- Human error and DI
- Human behaviours that help protect data integrity
- Doing the wrong thing for the right reason
- Quality culture
- Controls for paper-based records
- Errors relating to computer systems
- Leverage audit trails
- Understand what Data Integrity means
- Understand why Data Integrity is a hot topic
- Understand data criticality and data risk
- Understand how Data Integrity problems arise
- Understand who can contribute to good Data Integrity
- Understand how to protect your Data Integrity
cGMP: Data Integrity is included in the following professional certification programs:
Price: $1795.00 (USD) | Learn more
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 validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: 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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
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.