|Program/Course ID: CGMP02|
Enrollment Period: 3 months.
Allocated Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Good Documentation Practices.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
PRICE: USD $195.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: GDocP: Good Documentation Practice
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
Good Manufacturing Practice (GMP) for medicinal products relies on documentation. Good Documentation Practice (GDocP) is that part of GMP that applies to the creation, maintenance, use, and retention of documents to provide assurance of data integrity and the quality of products.
In this module, we emphasize the crucial importance of GDocP and we identify five principles that underpin it. We explain the functions of the various types of documents that are used and discuss how they should be created and controlled. Finally, we set out requirements for record keeping; how data are to be entered into records, corrected if necessary, and how records must be retained.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying 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. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The 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 verify training, and can be displayed on social networking sites, such as LinkedIn.
An outline of the module's scope and objectives, and notes on terminology.
Importance and principles of GDocP:
Good Documentation Practice underpins Good Manufacturing Practice. In this session we emphasize the crucial importance of compliance with, and we identify fundamental principles of GDocP.
Types of documents:
In this session we describe the various types of documents found in a GMP-compliant environment; their functions, contents, and relationships.
Document creation and control:
Careful control of GMP-relevant documentation is vitally important for quality management. In this session we identify principles of document control and characteristics of controlled documents, outline how documents should be created and maintained, and give advice on good practice in the creation of templates or masters for records.
Scrupulous and thorough recording of manufacturing activities is very important for maintaining data integrity and a variety of other reasons. In this session we set out these reasons, we provide rules for recording and correcting data in compliance with GMP requirements, and we specify requirements for the retention of records.
Multiple-choice mastery assessment.
Who will benefit from this module?
Everyone who works in a manufacturing environment in the pharma/biotech industry will benefit from this module. It will be of especial interest to quality assurance staff.
- Explain why Good Documentation Practice is important, and identify principles that underpin it
- List the various types of documents used and explain their functions
- Discuss how documents should be created and controlled
- Specify requirements for record keeping and data integrity, including those for entering and correcting data
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.