GDocP: Good Documentation Practices and Data Integrity
 | Enrollment Period: 6 months. Average Learning Time: ~60 minutes. Additional Resources: Supplemental materials/activities. Accredited Program: 0.1 CPD Credits. Method of Training: Online, Asynchronous, Self-paced eLearning. Accessibility: 24/7 access to all program materials. 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: $199.00 USD |
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: GDocP: Good Documentation Practices and Data IntegrityTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  This course has been designed to help you understand Good Documentation Practices in the light of Data Integrity requirements. Despite numerous regulatory guidelines poor documentation practice has become more and more a global problem and in most cases, it leads to severe violations of data integrity principles. By completing this online training course, you will versed in all aspect of GDocP in a regulated manufacturing environment.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. |
Outline:Introduction Overview Learning objectives Who should take this course? Course modules The Starting Line Overview What are Good Documentation Practices (GDocP)? Examples Entire document life cycle Create a SOP Benefits of GDocP General Rules Overview Document Types Fundamentals of Good Documentation Practices - Part 1 Fundamentals of Good Documentation Practices - Part 2 Signatures Document control Minimum number of approvers Never back date! Specimen file Electronic systems Date and time format Good practice Be consistent Format Languages - Correct grammar Use indelible ink Do not Blue of black Scrap paper and post-its Transcribing Late Entries Blank fields Annotations Additional pages Instrument print-outs Ditto Corrections Overview Making corrections Draw a Line Explanation codes Correction tape & fluid Explanations for the correction Verification Multiple corrections Avoid asterisks Review activity Logbooks Overview Elements of a Logbook Supporting Procedures Keep On-Site Data entering ground rules Reviewing recorded data Examples Retrieving logbooks Logbook auditing Signature blocks Page numbering Avoid gaps Attachments and print-outs General Test Results Overview Protocol Generation Protocol Execution Tips Variable Data Errors Can Be Costly Expected Results Calculations & Formula Oops & Uh-Ohs Accountability Rules of Thumb Units of Measurement Attachment -Reminder Legal Factors Review activity Conclusion Final assessment Certification | Objectives:Skill Level: Basic This training program has been developed to train employees with Basic Knowledge of Good Documentation Practices (GDocP). | |
Benefits of Training with Biopharma Institute
- Immediate access to courses: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced, asynchronous eLearning: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: Courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: Courses are current with respect to regulations, procedures, and are 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: Website and LMS provide an encrypted connection, including firewall protection and daily scans for malware, to deliver optimal level of security and performance.
- Flexible final assessments: Assessments 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.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- SCORM-compliant courses: Courses can be delivered directly from most corporate Learning Management Systems (LMS).
- Purchase orders (POs): POs are accepted from all companies. You must request an invoice to start the procurement process.
- Reimbursement: Some employers may reimburse their employees for training expenses. Check your company's education reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. Alternatively, purchasing individual courses one at a time is also an option.
- Career advancement: Professional certifications help demonstrate interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer taking points for the interview, and practical knowledge for performing the work.
