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Wednesday, February 01, 2023
Home » Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals

Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals

Certification Training
Rated 4.3 / 5
3 reviews
Program/Course ID: CP006a
Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, Asynchronous, Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Credit Hours: 2 credits.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: 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: Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals
Training Provided By: Biopharma Institute

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

Biopharma Institute ReviewsSponsors, CROs, and research sites are required by regulatory authorities and GCP to have an effective process to manage significant noncompliance through corrective and preventive action (CAPA) plans. These stakeholders should have procedures to support their CAPA system and documentation. Team members must understand a CAPA process and how it links into quality risk management. This training is designed to provide this understanding and is an essential companion to training on a company specific CAPA system. It is also a foundation for the CAPA process and supports understanding through GCP industry specific case scenarios and other application exercises in each section.

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.


  • 1. Introduction to CAPA Process Training

  • 2. Foundations of Quality Systems
  • a. Clinical Quality Management System
  • b. What is a QMS?
  • c. QMS Elements
  • d. Quality Risk Management
  • e. ICH E6(R2) 5.0
  • f. Risks That Matter
  • g. Issues That Matter
  • h. Complete Risk-Based Approach Map

  • 3. Risks and Issues That Matter
  • a. Regulatory Inspection Example
  • b. Cost of Poor Performance
  • c. What Happened Next?
  • d. Regulatory Authorities and Noncompliance
  • e. What is a Noncompliance
  • f. Significant Noncompliance Links to Regulatory Requirements
  • g. Noncompliance Significance

  • 4. The CAPA Process
  • a. Example Scenario
  • b. A CAPA Decision Process
  • c. Source of Information for Risks and Issues That Matter
  • d. The CAPA Process Steps
  • e. Additional Key Activities

  • 5. The CAPA Case Scenario
  • a. Case Scenario #1
  • b. A CAPA Decision Process Walk Through
  • c. Case Scenario #2
  • d. Common CAPA Challenges
  • e. Opportunity for Additional Case Scenario

  • 6. 10 Question Post Assessment


  • Recognize why corrective and preventive actions are essential in maintaining quality in a clinical trial.
  • Apply the steps of the CAPA process in clinical trial scenarios.
  • Discuss challenges in performing CAPA activities and review potential solutions.

A foundation training applicable for all sponsor clinical team members and contractors. A more detailed and customized course with therapeutic area specific scenarios can be developed for sponsors for in person or online workshops.

Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, 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 with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • 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.

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.