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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
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Program/Course ID: CP006a
Enrollment Period: 12 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: Three (3) 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 12-month period. 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 courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 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:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions 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 verifiable online with digital badges issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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.