CAPA – Corrective and Preventive Actions
Course duration: Allow 1.5 to 2 hours to complete this course.
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CAPA Course on Corrective and Preventive Actions
cGMP regulations and documentation requirements for CAPA
Whether you’re responding to a root cause investigation of a deviation — or initiating a continuous improvement — Corrective and Preventive Actions (CAPA) – must be managed according to cGMP regulations.
cGMP requirements for corrective and preventive actions (CAPA) include but are not limited to:
- thorough investigations of deviations/non-conformance incidents
- providing adequate and ongoing training for personnel and contractors in cGMP regulations and product-specific Annexes as well as deviation management and CAPAs
- conducting ‘root cause analysis (RCA)‘ to determine if a CAPA needs to be initiated
- monitoring the effectiveness of corrective and preventive actions taken (CAPAs)
- management reviews of deviations/non-conformances, CAPAs, complaints, and adverse effects
- trends analysis of quality issues
- impact assessments/risk assessments
- documenting all processes
- documenting the justification for actions and product disposition decisions, and more
This newly-released CAPA Course — when completed along with the Deviations and Non-Conformances management course — will help you understand what’s required of all GMP personnel, Department Managers, Quality Managers, and Business Owners when implementing CAPAs (corrective and preventive actions) in relation to deviations and other quality issues.
Implementing CAPAs in GMP environments must be appropriate, justified, and fully documented and monitored during implementation. Learn what’s required in GMP regulations for CAPA systems and documentation in this CAPA training course — available online!
GMP industry training experts
The course provides learners with PIC/S cGMP guidance including international regulations and standards for planning and implementing corrective and preventive actions (CAPAs).
- This is one of our many GMP education topics eLearning courses available 24/7.
- It is a follow-up course to the cGMP deviations management course and a precursor to the completion of a Complaints management training course for GMP personnel and Managers.
- Click here for a list of face-to-face courses delivered via Zoom, including CAPA (onsite training of large groups of personnel may also be available, where feasible).
With online training for CAPA implementation and GMP requirements, you can mix and match GMP education courses with a training bundle package OR alternatively, you can purchase a single course or just a few.
Note: One learner, one cGMP course completion Certificate per course purchase.
The learner will have 12 months’ access to the course and a downloadable online CAPA training certificate of completion.
Do you need to train your personnel to follow SOPs for CAPA?
- If you need to train large numbers of employees on CAPA, complaints management, and/or Deviations and Non-Conformances Management in a GMP environment, contact us for a quote.
- You can alternatively order discounted GMP education topics/GMP training bundles.
- If you’re purchasing this course for yourself and your future career in the pharmaceutical industry, consider the customisable 4-bundle course packages.
Note: All course prices are in US dollars.
Bundled training options let you ‘mix and match’ standard courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.
This certificate GMP training course for CAPA is ideally suited for:
- Anyone working in the pharmaceutical or medical device industry
- Anyone with a job role related to:
- cGMP manufacturing including medicines, biologicals/blood products/human tissues, medical devices, and veterinary medicines
- packaging/labelling zones
- quality control
- complaints handling
- Quality management professionals
- Production line personnel
- Manufacturing Licence holders (MAH/medicine manufacturers)
- Administration personnel
What does the acronym “CAPA” mean?
Definition of CAPA (GMP)
The Acronym CAPA in GMP environments stands for ‘corrective and preventive actions.’ These are actions that might be considered and implemented in response to a manufacturing issue or production error, a product defect, a product deviation, a non-conformance finding or out-of-specification testing result, and/or other quality management issues. Corrective actions are remedial actions, and preventive actions are part of the broader scope of quality risk management (QRM).
About this Pharmaceutical Industry training course
- The CAPA GMP regulations training course is based on PIC/S publication and insights from pharmaceutical manufacturing industry experts (GMP consultants).
- It includes examples of PICS/S guidelines for deviations management and/or non-conformances (GMP recordkeeping and deviation management processes and procedures, such as product impact assessments/criticality), and examples of CAPA system expectations from various regulatory authorites.
- Completion of any of our online GMP courses will enable you to print your GMP topic Course Certificate — and earn a Credly badge for your social media channels.
- You can also attach your Certificate of Completion to your CV when applying for jobs in the pharmaceutical sector.
Topics explored in the training presentation / GMP eLearning course for management of CAPA include:
- GMP regulations for CAPA (corrective and preventive actions)
- Personnel responsibilities for CAPA implementation
- Deviation management procedures and scenarios that may lead to a CAPA
- Impact assessments
- Requirements for documenting justifications and other CAPA information
- Product disposition
- Product Quality Reviews and CAPA effectiveness checks
- When to initiate a CAPA (click here to register your interest in attending a live-streamed CAPA course GMP presentation)
- Review other top-ranked GMP courses and best-practice GMP training courses.
Snapshot of this certificate GMP online training course:
- This course focuses on cGMP requirements for managing corrective and preventive actions (CAPAs) and CAPA system expectations during regulatory audits by the TGA, FDA, other regional Regulatory Authorities.
- This training course also reviews:
- creating a cGMP compliance culture
- continuous improvement approaches
- The course is ideally suited for anyone working in the pharmaceutical industry including individuals working in the production and/or distribution of APIs (active pharmaceutical ingredients), ATMPS, biologicals, sterile medicines, medical device manufacturing, regulated cosmetic sectors (medical-cosmetic product manufacturing), etc.
How to complete this course.
- Add the course to your basket and complete your purchase.
- Remember, the course fees are listed in US Dollars.
- Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised.
- Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.
One user/per licence purchase (12 months’ access)
- This newly-released CAPA cGMP regulations course is available online, one user per licence.
- Course completion provides learners with a foundational understanding of CAPA system requirements including recordkeeping and personnel responsibilities in GMP environments.
Who should take this online CAPA course?
The course should be completed by any professional in a GMP environment.
Examples: Sponsors/manufacturers of medicines, Production Line personnel, Department Managers, Quality Managers, Authorised Persons/Qualified Persons, Manufacturing Contractors/Suppliers, Complaints Managers/Pharmacovigilance professionals, Data Integrity compliance managers, and more.
This course will be particularly beneficial for:
- Pharmace utical Quality Department members (Quality Managers)
- Area Managers/Department leaders
- Laboratory/testing laboratory personnel (chemists, scientists, researchers, etc)Authorised Person(s) / Qualified Persons
- Operations Managers
- Production line workers
- Medicine Sponsors
- University students working in life-science industries
- Sponsors of Clinical Trials (Phase II and onwards)
- Owners/Operations Managers
- PQS personnel conducting self-inspections
- Professionals involved with
- batch traceability records
- complaints handling
- product recall procedures
- Anyone involved in quality system management
- Purchasing Managers/Logistics Managers
GMP Training Course Benefits:
- The training course will assist personnel to understand Regulatory expectations for CAPA systems, including procedures and CAPA recordkeeping requirements.
- This course will assist personnel of all levels to recognise GMP regulatory expectations and may help you establish a more GMP aware/cGMP compliant culture in your organisation.
Allow 1.5 to 2 hours to complete this GMP regulations/Deviations and Non-Conformances eLearning training course including the online Final Assessment.
Other recommended courses include:
Back to the online GMP training store.
Are your SOPs for deviation management out of date?
- Click here for Deviation Management examples and templates.
- Technical writers for SOPs are also available as PQS/QMS consultants/writers.