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GDocP: Good Documentation Practices and Data Integrity

Certification Training
 
Rated 4.5 / 5
4 reviews
Program/Course ID: ELM-104
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.
CPD Accredited TrainingDemonstration: 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 Integrity
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
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 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.


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.