CAPA – Corrective and Preventive Actions

Description

This eLearning course provides comprehensive training on Corrective and Preventive Actions (CAPA) within the context of cGMP regulations. Designed for professionals in the pharmaceutical, veterinary medicine, and medical device industries, this course helps personnel and Regulatory Authorities understand CAPA planning, implementation, and compliance requirements.

CAPA Course Overview

Completing this interactive CAPA training course will provide learners with an in-depth understanding of CAPA regulatory expectations and industry best practices.

• Covers GMP/cGMP requirements for managing CAPAs.
• Clarifies the distinction between corrective and preventive actions.
• Explains CAPA planning, implementation, and root cause investigation requirements.
• Provides insight into risk assessments, root cause analysis, and impact assessments.
• Includes case studies and CAPA warning letter examples from global Regulatory Authorities.
• Supports personnel in preparing for audits and compliance inspections.

Key Learning Topics for CAPA Training

This course includes an overview of CAPA-related regulations and quality management system expectations, including:

CAPA Fundamentals

📌Definition and importance of CAPAs in GMP environments.
📌Differences between corrective and preventive actions.
📌When and how to implement CAPAs.

CAPA Regulatory Requirements

Compliance expectations from major global regulators, including:

📌US FDA (21 CFR Part 820, 21 CFR Part 211, and MoCRA).
📌European Medicines Agency (EMA).
📌UK Medicines and Healthcare Products Regulatory Agency (MHRA).
📌Australian Therapeutic Goods Administration (TGA).
📌PIC/S GMP guidelines.
📌ISO 13485 QMS for medical devices.

CAPA Processes and Implementation

📌Root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagrams, FMEA).
📌CAPA documentation and recordkeeping.
📌Conducting risk assessments and impact evaluations.
📌CAPA effectiveness checks and continuous improvement strategies.

CAPA Case Studies and Regulatory Insights

📌Review of real-world CAPA case studies.
📌Analysis of CAPA warning letters and compliance enforcement actions.
📌Common CAPA implementation pitfalls and how to avoid them.

Who Should Complete this Course?

This training will help participants understand CAPA requirements in the context of global GMP compliance frameworks. It is suitable for a wide range of industry professionals, including:

✅ Quality Assurance & Quality Control Personnel
✅ Manufacturing & Production Personnel
✅ Operations & Product Line Managers
✅ Regulatory Affairs & Compliance Specialists
✅ Supply Chain & Logistics Managers
✅ GMP Auditors & Site Inspectors
✅ Research & Development (R&D) Teams
✅ Regulatory Authority Representatives
✅ Medical Device & Pharmaceutical Industry Personnel

Flexible Online Learning Format

This self-paced eLearning course allows participants to:
✔️ Access course materials anytime, anywhere (valid for 12 months from date of purchase)
✔️ Learn at their own pace with real-world Case Studies & Data Integrity warning letters
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

CAPA Training Certificate

Upon successful completion of this course, learners will receive a CAPA (GMP) Training Certificate of Completion  which can be used to demonstrate compliance training in job applications, audits, and personnel records.

• The certificate validates an individual’s knowledge of CAPA regulatory expectations and best practices.
• It is recommended to review relevant GMP regulations and standards both before and after completing the course.

Additional GMP Training Courses

This CAPA training course is part of a broader suite of GMP compliance courses, including:

• Managing Complaints (GMP Guidelines).
• Deviation & Non-Conformance Management Training.
• Pharmacovigilance & Product Recalls Training.
• ISO 13485 & ISO 14971 Risk Management for Medical Devices.
• Click the “store” menu item to review all relevant courses (over 70 to choose from)!

 

Pricing & Bulk Training Packages

• Single Course Purchase: Available in USD with immediate access upon registration.
• Bundle Discount: Special pricing is available when purchasing four or more courses.
• Corporate Training: Custom packages for training large teams (50+ employees) are available upon request.

Why Choose PharmOut?

PharmOut specializes in providing industry-leading GMP compliance training that is:

• Comprehensive yet concise, with plain-language explanations and multimedia content.
• Globally relevant, incorporating GMP regulations from FDA, EMA, MHRA, TGA, PIC/S, and ISO standards.
• Delivered with flexibility including online courses and live-streamed or in-person training options featured on the PharmOut website.

For more details on public courses or training inquiries for large teams, contact PharmOut today!

RESOURCES and recommended reading

• Top 10 pharmaceutical industry blogs (top 10 GMP blogs)
• Pharmaceutical Industry Jobs: 5 Essential Skills

Are your SOPs for deviation management out of date?

• Click here for Technical writing/SOP writing support
• Click here for QMS documentation examples and templates
• Review our GMP Consultancy services. Get project and upgrade support from GMP industry experts and pharmaceutical and medical device industry consultants, regulatory affairs experts, cleanroom engineers, validation experts, and medical device industry consultants.