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GDocP: Good Documentation Practices and Data Integrity

GDocP: Good Documentation Practices and Data Integrity Certification Training

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Program/Course ID:ELM-104
Enrollment Period:12 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.
Catalog:Good Documentation Practices.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training:Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $199.00 USD  
CPD Accredited Training

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

Training Program: GDocP: Good Documentation Practices and Data Integrity
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Biopharma Institute ReviewsThis 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 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

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 promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

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.


Learning objectives
Who should take this course?
Course modules

The Starting Line
What are Good Documentation Practices (GDocP)?
Entire document life cycle
Create a SOP
Benefits of GDocP

General Rules
Document Types
Fundamentals of Good Documentation Practices - Part 1
Fundamentals of Good Documentation Practices - Part 2
Document control
Minimum number of approvers
Never back date!
Specimen file
Electronic systems
Date and time format
Good practice
Be consistent
Languages - Correct grammar
Use indelible ink
Do not
Blue of black
Scrap paper and post-its
Late Entries
Blank fields
Additional pages
Instrument print-outs

Making corrections
Draw a Line
Explanation codes
Correction tape & fluid
Explanations for the correction
Multiple corrections
Avoid asterisks
Review activity

Elements of a Logbook
Supporting Procedures
Keep On-Site
Data entering ground rules
Reviewing recorded data
Retrieving logbooks
Logbook auditing
Signature blocks
Page numbering
Avoid gaps
Attachments and print-outs

General Test Results
Protocol Generation
Protocol Execution Tips
Variable Data
Errors Can Be Costly
Expected Results
Calculations & Formula
Oops & Uh-Ohs
Rules of Thumb
Units of Measurement
Attachment -Reminder
Legal Factors
Review activity


Final assessment



Skill Level:

This training program has been developed to train employees with Basic Knowledge of Good Documentation Practices (GDocP).

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 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:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.