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Home » GMP: Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture

GMP: Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture (CGMP07)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingDemonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GMP: Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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.

Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at Biopharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the Biopharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The Biopharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. By coupling new automated tracking systems with proven and advanced e-learning training techniques, the Biopharma Institute can do for you and your company what we have done for numerous companies - both abroad and within the USA. We can assist in the maintaining of training records, the education of your employees, and with an overall improvement in the quality of service you offer.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE OUTLINE:


Module overview
An outline of the module's scope and objectives, and notes on terminology.

CAPA principles
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.

CAPA procedure
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.

Assessment
Multiple-choice mastery assessment.

COURSE OBJECTIVES:


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.

Learning objectives

- 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.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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