CAPA – Corrective and Preventive Actions
USD $35.00
Course duration: Allow 1.5 to 2 hours to complete this course.
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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
๐Definition and importance of CAPAs in GMP environments.
๐Differences between corrective and preventive actions.
๐When and how to implement CAPAs.
CAPA Regulatory Requirements
Compliance expectations from major global regulators, including:
๐US FDA (21 CFR Part 820, 21 CFR Part 211, and MoCRA).
๐European Medicines Agency (EMA).
๐UK Medicines and Healthcare Products Regulatory Agency (MHRA).
๐Australian Therapeutic Goods Administration (TGA).
๐PIC/S GMP guidelines.
๐ISO 13485 QMS for medical devices.
CAPA Processes and Implementation
๐Root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagrams, FMEA).
๐CAPA documentation and recordkeeping.
๐Conducting risk assessments and impact evaluations.
๐CAPA effectiveness checks and continuous improvement strategies.
CAPA Case Studies and Regulatory Insights
๐Review of real-world CAPA case studies.
๐Analysis of CAPA warning letters and compliance enforcement actions.
๐Common 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:
โ
Quality Assurance & Quality Control Personnel
โ
Manufacturing & Production Personnel
โ
Operations & Product Line Managers
โ
Regulatory Affairs & Compliance Specialists
โ
Supply Chain & Logistics Managers
โ
GMP Auditors & Site Inspectors
โ
Research & Development (R&D) Teams
โ
Regulatory Authority Representatives
โ
Medical Device & Pharmaceutical Industry Personnel
Flexible Online Learning Format
Thisย self-paced eLearning courseย allows participants to:
โ๏ธย Access course materials anytime, anywhereย (valid for 12 months from date of purchase)
โ๏ธย Learn at their own paceย with real-world Case Studies & Data Integrity warning letters
โ๏ธย Combine online learning with instructor-led training optionsย (virtual or onsite, where available)
CAPA Training Certificate
Upon successful completion of this course, learners will receive a CAPA (GMP) Training Certificate of Completionย which can be used to demonstrate compliance training in job applications, audits, and personnel records.
- The certificate validates an individualโs 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
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