Instructor :
Charles H. Paul

Webinar ID:
10621

The Corrective and Preventive Action (CAPA) system is a crucial element of quality management in the Life Sciences industry, meticulously scrutinized during FDA inspections.

This 90-minute webinar delves into the critical role of CAPA systems in identifying and addressing non-conformances before they escalate.

Key Insights:

• • FDA’s Focus on CAPA: Inadequate failure investigations are among the top deficiencies flagged by the FDA. With nearly 20% of 1,000 annual inspections leading to warning letters, the importance of a robust CAPA system cannot be overstated.
  • High Stakes of Non-Compliance: The average fine for CAPA-related violations is a staggering $1.5 million, highlighting the financial risks of non-compliance.

What You’ll Learn:

• • Latest Regulations: Stay updated on the latest CAPA regulations and learn exactly what the FDA expects during inspections.
  • CAPA Execution Mastery: Discover how to initiate and manage CAPAs effectively, keeping your organization compliant and competitive.
  • Effective Investigations: Gain skills in conducting thorough failure investigations and root cause analyses, essential components of a resilient CAPA system.

Elevate Your CAPA Process: This webinar goes beyond the basics, integrating emerging trends like digitalization, AI, data integrity, and risk management into the CAPA framework. Understand how these elements can transform your CAPA processes, ensuring they are not only effective but also FDA-compliant.

What You Will Gain:

• • Heightened Awareness: Learn the profound impact of proper CAPA execution on compliance, product efficacy, and patient safety.
  • Strategic Insights: Equip yourself with the knowledge to navigate the complexities of CAPA management and avoid common pitfalls that lead to FDA warnings and fines.

Unlock the full potential of your CAPA system and ensure it stands strong under FDA scrutiny. Secure your compliance and protect your customers.

Join Now!

The Corrective and Preventive Action (CAPA) system is a crucial element of quality management in the Life Sciences industry, meticulously scrutinized during FDA inspections.

This 90-minute webinar delves into the critical role of CAPA systems in identifying and addressing non-conformances before they escalate.

Key Insights:

• • FDA’s Focus on CAPA: Inadequate failure investigations are among the top deficiencies flagged by the FDA. With nearly 20% of 1,000 annual inspections leading to warning letters, the importance of a robust CAPA system cannot be overstated.
  • High Stakes of Non-Compliance: The average fine for CAPA-related violations is a staggering $1.5 million, highlighting the financial risks of non-compliance.

What You’ll Learn:

• • Latest Regulations: Stay updated on the latest CAPA regulations and learn exactly what the FDA expects during inspections.
  • CAPA Execution Mastery: Discover how to initiate and manage CAPAs effectively, keeping your organization compliant and competitive.
  • Effective Investigations: Gain skills in conducting thorough failure investigations and root cause analyses, essential components of a resilient CAPA system.

Elevate Your CAPA Process: This webinar goes beyond the basics, integrating emerging trends like digitalization, AI, data integrity, and risk management into the CAPA framework. Understand how these elements can transform your CAPA processes, ensuring they are not only effective but also FDA-compliant.

What You Will Gain:

• • Heightened Awareness: Learn the profound impact of proper CAPA execution on compliance, product efficacy, and patient safety.
  • Strategic Insights: Equip yourself with the knowledge to navigate the complexities of CAPA management and avoid common pitfalls that lead to FDA warnings and fines.

Unlock the full potential of your CAPA system and ensure it stands strong under FDA scrutiny. Secure your compliance and protect your customers.

Join Now!

In the highly regulated Life Sciences industry, proficiency in CAPA systems is essential for maintaining compliance and enhancing product quality.

Regulatory agencies conduct thousands of inspections annually, and CAPA system violations are frequently at the forefront of compliance issues.

Overcoming CAPA Challenges:

• • Broad Scope: Ensure your CAPA system addresses not only product-specific issues but also broader quality concerns, including process and systemic problems.
  • Common Pitfalls: Avoid the mistake of treating CAPA superficially. Many organizations focus on immediate corrections without implementing true corrective and preventive actions, which can lead to recurring issues.

Why Attend: By attending this webinar, you will gain insights into best practices and learn the pitfalls to avoid, enhancing your ability to oversee and improve your quality systems. You’ll acquire actionable strategies to prepare for FDA inspections and manage CAPA systems effectively.

Webinar Highlights:

• • Critical Steps: Delve into every essential phase of the CAPA process, ensuring nothing is overlooked.
  • Effective Timing and Participation: Learn the optimal timing for CAPA execution and how to engage the right participants for effective management.
  • Avoiding Pitfalls: Understand common mistakes in CAPA investigations and how to avoid them for better outcomes.
  • Achieve CAPA Excellence: Gain practical insights into executing a thorough and effective CAPA process.

Transform your approach to CAPA and investigations. Enroll now!

In the highly regulated Life Sciences industry, proficiency in CAPA systems is essential for maintaining compliance and enhancing product quality.

Regulatory agencies conduct thousands of inspections annually, and CAPA system violations are frequently at the forefront of compliance issues.

Overcoming CAPA Challenges:

• • Broad Scope: Ensure your CAPA system addresses not only product-specific issues but also broader quality concerns, including process and systemic problems.
  • Common Pitfalls: Avoid the mistake of treating CAPA superficially. Many organizations focus on immediate corrections without implementing true corrective and preventive actions, which can lead to recurring issues.

Why Attend: By attending this webinar, you will gain insights into best practices and learn the pitfalls to avoid, enhancing your ability to oversee and improve your quality systems. You’ll acquire actionable strategies to prepare for FDA inspections and manage CAPA systems effectively.

Webinar Highlights:

• • Critical Steps: Delve into every essential phase of the CAPA process, ensuring nothing is overlooked.
  • Effective Timing and Participation: Learn the optimal timing for CAPA execution and how to engage the right participants for effective management.
  • Avoiding Pitfalls: Understand common mistakes in CAPA investigations and how to avoid them for better outcomes.
  • Achieve CAPA Excellence: Gain practical insights into executing a thorough and effective CAPA process.

Transform your approach to CAPA and investigations. Enroll now!

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Understanding CAPA: Definition and Scope

• • Explore the fundamentals of Corrective and Preventive Actions (CAPA), defining its key elements and the scope within regulatory compliance.

Regulatory Framework: CAPA Regulations Explained

• • Delve into the specific regulations that govern CAPA systems, including critical insights into legal requirements and compliance expectations.

Navigating the CAPA Process: Overview of Flow

• • An overview of the CAPA process flow, providing a clear path from identification to resolution of issues.

Detailed Guide: Steps in the CAPA Process

• • A step-by-step breakdown of the CAPA process, detailing each phase from initiation through closure and follow-up.

Reporting Mechanisms: Handling Exceptions and Deviations

• • Learn about effective reporting mechanisms for managing exceptions and deviations, emphasizing accuracy and timeliness in documentation.

CAPA Challenges: Common Pitfalls and Solutions

• • Identify common challenges and pitfalls in the CAPA process and discuss practical solutions to overcome these obstacles.

Strategic Approach: Integrating CAPA in Risk Mitigation

• • Highlight the strategic role of CAPA in risk mitigation, illustrating how to integrate CAPA into broader quality and risk management frameworks

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

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Understanding CAPA: Definition and Scope

• • Explore the fundamentals of Corrective and Preventive Actions (CAPA), defining its key elements and the scope within regulatory compliance.

Regulatory Framework: CAPA Regulations Explained

• • Delve into the specific regulations that govern CAPA systems, including critical insights into legal requirements and compliance expectations.

Navigating the CAPA Process: Overview of Flow

• • An overview of the CAPA process flow, providing a clear path from identification to resolution of issues.

Detailed Guide: Steps in the CAPA Process

• • A step-by-step breakdown of the CAPA process, detailing each phase from initiation through closure and follow-up.

Reporting Mechanisms: Handling Exceptions and Deviations

• • Learn about effective reporting mechanisms for managing exceptions and deviations, emphasizing accuracy and timeliness in documentation.

CAPA Challenges: Common Pitfalls and Solutions

• • Identify common challenges and pitfalls in the CAPA process and discuss practical solutions to overcome these obstacles.

Strategic Approach: Integrating CAPA in Risk Mitigation

• • Highlight the strategic role of CAPA in risk mitigation, illustrating how to integrate CAPA into broader quality and risk management frameworks

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

Maximize the Learning Experience in A Group Setting!

Anyone involved in the manufacturer of pharmaceutical products, foods, beverages, cosmetics, and medical devices.

FUNCTIONS

• • Marketing
  • Research & Development
  • Technical Services
  • Manufacturing
  • Compliance and Regulatory
  • Logistics/Supply chain
  • Service and Maintenance

POSITIONS

• • Associates
  • Supervisors
  • Managers
  • Directors
  • Vice Presidents

Maximize the Learning Experience in A Group Setting!

Anyone involved in the manufacturer of pharmaceutical products, foods, beverages, cosmetics, and medical devices.

FUNCTIONS

• • Marketing
  • Research & Development
  • Technical Services
  • Manufacturing
  • Compliance and Regulatory
  • Logistics/Supply chain
  • Service and Maintenance

POSITIONS

• • Associates
  • Supervisors
  • Managers
  • Directors
  • Vice Presidents