|Program/Course ID: CGMP07|
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 Manufacturing Practice (cGMP).
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: GMP: Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
A company's Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.
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.
In this session we explain what a CAPA system is and why it is important. We explain the differences among correction, containment, corrective action, and preventive action. We specify sources of information about manufacturing problems, and we emphasize the importance of documentation of a CAPA system.
Problems that may give rise to CAPAs are best tackled by systematically progressing through a number of stages of procedure. In this session we set out the typical stages of a CAPA procedure, along with the questions to be addressed and the actions taken at each stage.
Root cause analysis
Root cause analysis is a rigorous approach to finding the deepest causes of problems. In this session we emphasize the value of applying CAPA to root causes rather than their symptoms. We set out the stages of a typical analysis, and we list examples of tools for finding causes and studying trends.
Tracking, escalation, and trending
One of the most common findings of regulatory inspectors is the lack of effective and timely closure of CAPA reports. In this short session we emphasize the importance of tracking the progress of CAPA procedures, escalating issues, and reviewing trends in the CAPA system.
Multiple-choice mastery assessment.
Who will benefit from this module?
This module provides essential training for all personnel who work in a manufacturing environment in the pharma/biotech industry.
- Explain what a CAPA system is and describe how it operates in a company's Quality Management System
- Describe how a typical CAPA procedure is carried out
- Outline the purpose and practice of root cause analysis
- Discuss the role of progress tracking, escalating, and trending of CAPA procedures
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.