Instructor :
Charles H. Paul

Webinar ID:
13736

Corrective and Preventive Action (CAPA) failures remain one of the most frequently cited deficiencies in FDA inspections. With the agency conducting over 1,000 inspections annually and nearly 20% leading to warning letters, organizations cannot afford weak CAPA systems.

Non-compliance can result in severe financial penalties, product recalls, and reputational damage.

This expert-led webinar provides a deep dive into FDA expectations, common CAPA pitfalls, and best practices to build a resilient, audit-ready CAPA system.

Key Takeaways:

• • Understand FDA CAPA Regulations
    • • Gain clarity on regulatory requirements and how to align your processes with FDA expectations.

• • Master CAPA Execution
    • • Learn step-by-step methods to initiate, manage, and close CAPAs effectively to ensure compliance.

• • Conduct Effective Root Cause Investigations
    • • Improve failure investigations and prevent recurring issues with proven techniques.

• • Leverage Modern CAPA Enhancements
    • • Explore how digitalization, AI, data integrity, and risk management can elevate CAPA effectiveness.

By the end of this training, you’ll have a clear roadmap to ensure your CAPA system meets FDA standards, reducing the risk of compliance failures and costly penalties.

Join us to transform your CAPA process and protect your organization from regulatory setbacks!

Enroll Now!

Corrective and Preventive Action (CAPA) failures remain one of the most frequently cited deficiencies in FDA inspections. With the agency conducting over 1,000 inspections annually and nearly 20% leading to warning letters, organizations cannot afford weak CAPA systems.

Non-compliance can result in severe financial penalties, product recalls, and reputational damage.

This expert-led webinar provides a deep dive into FDA expectations, common CAPA pitfalls, and best practices to build a resilient, audit-ready CAPA system.

Key Takeaways:

• • Understand FDA CAPA Regulations
    • • Gain clarity on regulatory requirements and how to align your processes with FDA expectations.

• • Master CAPA Execution
    • • Learn step-by-step methods to initiate, manage, and close CAPAs effectively to ensure compliance.

• • Conduct Effective Root Cause Investigations
    • • Improve failure investigations and prevent recurring issues with proven techniques.

• • Leverage Modern CAPA Enhancements
    • • Explore how digitalization, AI, data integrity, and risk management can elevate CAPA effectiveness.

By the end of this training, you’ll have a clear roadmap to ensure your CAPA system meets FDA standards, reducing the risk of compliance failures and costly penalties.

Join us to transform your CAPA process and protect your organization from regulatory setbacks!

Enroll Now!

CAPA failures remain a leading cause of FDA warning letters, product recalls, and compliance fines in the life sciences industry.

Many organizations struggle with superficial CAPA execution, addressing only immediate issues without implementing true systemic corrective and preventive actions. This results in repeat failures, increased regulatory scrutiny, and financial penalties.

This high-impact training will help you:

• • Ensure a Holistic CAPA Approach
    • • Go beyond product defects and address process, system, and quality issues.

• • Avoid Common Pitfalls
    • • Learn why many CAPA systems fail and how to prevent recurring compliance risks.

• • Master CAPA Execution
    • • Understand the right timing, participation, and strategies for an effective CAPA process.

• • Stay Audit-Ready
    • • Gain expert insights into FDA expectations and ensure your CAPA system withstands regulatory inspections.

If you are responsible for quality, compliance, or regulatory affairs, this training is essential to protect your organization from preventable violations.

Enroll now and build a CAPA system that stands up to FDA scrutiny!

Register Today!

CAPA failures remain a leading cause of FDA warning letters, product recalls, and compliance fines in the life sciences industry.

Many organizations struggle with superficial CAPA execution, addressing only immediate issues without implementing true systemic corrective and preventive actions. This results in repeat failures, increased regulatory scrutiny, and financial penalties.

This high-impact training will help you:

• • Ensure a Holistic CAPA Approach
    • • Go beyond product defects and address process, system, and quality issues.

• • Avoid Common Pitfalls
    • • Learn why many CAPA systems fail and how to prevent recurring compliance risks.

• • Master CAPA Execution
    • • Understand the right timing, participation, and strategies for an effective CAPA process.

• • Stay Audit-Ready
    • • Gain expert insights into FDA expectations and ensure your CAPA system withstands regulatory inspections.

If you are responsible for quality, compliance, or regulatory affairs, this training is essential to protect your organization from preventable violations.

Enroll now and build a CAPA system that stands up to FDA scrutiny!

Register Today!

1. Introduction to CAPA

• • Definition, scope, and its role in quality and compliance
  • Why CAPA failures are a top FDA violation

2. Regulatory Expectations & Compliance

• • Key FDA regulations and guidelines governing CAPA
  • How to align CAPA systems with industry best practices

3. Exception Handling & Reporting

• • Identifying and documenting deviations and non-conformities
  • Best practices for reporting, tracking, and managing exceptions

4. Navigating the CAPA Process

• • Overview of CAPA workflow: From identification to resolution
  • Critical components of an effective CAPA system

5. Step-by-Step CAPA Implementation

• • Root cause analysis: How to conduct thorough investigations
  • Developing corrective and preventive actions that work
  • Effective CAPA documentation and record-keeping

6. Avoiding Common CAPA Pitfalls

• • Why CAPA systems fail: Key challenges and how to overcome them
  • Ensuring CAPA effectiveness and sustainability

7. CAPA as a Risk Mitigation Strategy

• • Integrating CAPA with risk management and continuous improvement
  • Leveraging AI, data integrity, and digital tools for CAPA success

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

1. Introduction to CAPA

• • Definition, scope, and its role in quality and compliance
  • Why CAPA failures are a top FDA violation

2. Regulatory Expectations & Compliance

• • Key FDA regulations and guidelines governing CAPA
  • How to align CAPA systems with industry best practices

3. Exception Handling & Reporting

• • Identifying and documenting deviations and non-conformities
  • Best practices for reporting, tracking, and managing exceptions

4. Navigating the CAPA Process

• • Overview of CAPA workflow: From identification to resolution
  • Critical components of an effective CAPA system

5. Step-by-Step CAPA Implementation

• • Root cause analysis: How to conduct thorough investigations
  • Developing corrective and preventive actions that work
  • Effective CAPA documentation and record-keeping

6. Avoiding Common CAPA Pitfalls

• • Why CAPA systems fail: Key challenges and how to overcome them
  • Ensuring CAPA effectiveness and sustainability

7. CAPA as a Risk Mitigation Strategy

• • Integrating CAPA with risk management and continuous improvement
  • Leveraging AI, data integrity, and digital tools for CAPA success

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Everybody benefits from watching this. Even better when done as a group!

• • Quality Assurance And Quality Control Professionals
  • Regulatory Affairs And Compliance Managers
  • CAPA And Investigation Team Members
  • Manufacturing And Operations Leaders In Life Sciences
  • Medical Device And Pharmaceutical Industry Professionals
  • Risk Management And Continuous Improvement Specialists
  • R&D And Product Development Teams In Healthcare
  • Anyone Responsible For FDA Compliance And Audits

Everybody benefits from watching this. Even better when done as a group!

• • Quality Assurance And Quality Control Professionals
  • Regulatory Affairs And Compliance Managers
  • CAPA And Investigation Team Members
  • Manufacturing And Operations Leaders In Life Sciences
  • Medical Device And Pharmaceutical Industry Professionals
  • Risk Management And Continuous Improvement Specialists
  • R&D And Product Development Teams In Healthcare
  • Anyone Responsible For FDA Compliance And Audits