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

GMP Training Course Costs  

  • Our online GMP training materials (online courses) are listed in US dollars.
  • Standard courses often cost $35 USD each, but there’s a special bulk rate when you purchase 4 or more in a bundle.
  • Not all courses are standard courses.

You can purchase a single course or just a few courses — whatever you need to enhance your onsite training program.

Do you need CAPA training for your personnel?

If you need to train large numbers of employees for complaints management, GMP Deviations and Non-Conformances Management, root cause analysis and CAPA implementation in a cGMP environment, you can contact us for a quote. Alternatively, you can 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.

All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.

Other cGMP Training/GMP education options

Why PharmOut?

PharmOut is committed to keeping pace with the global GMP regulatory changes including PIC/S, ISO standards, and other industry standards, in order to offer digestible, time and cost-effective courses helping the industry remain compliant.

Our GMP/cGMP training courses are concise yet thorough. They are available in self-paced, multi-media formats, using plain language and images to help users better learn GMP compliance requirements and industry standards. Examples include courses covering compliance guidance from the FDA CFRs, ISO 13485 and ISO 14971 standards for medical device manufacturers. 

On successful completion of your online course assessment (included with the course), course participants gain their cGMP/GMP course completion certificate. Note: PharmOut Pty Ltd also offers a range of additional industry training and GMP consulting services to suit your business or professional needs.

 

Expert Consultants for the Pharmaceutical & Medical Device Industries

Contact PharmOut for architectural, engineering, validation/equipment qualification and cleanroom expertise.

Are your SOPs for deviation management out of date?

Click here for Deviation Management examples and click here for QMS documentation examples and templates. Technical writers for SOPs and QMS system documentation are also available from our GMP pharmaceutical industry expert consultants, cleanroom engineers, validation experts, and medical device industry consultants.

 

 

An online training program to help Personnel and Regulatory Authorities understand CAPA requirements (Corrective and Preventive Actions) and relevant GMP compliance requirements.

CAPA Training

CAPAs in the Pharmaceuticals, Veterinary Medicines, and Medical Device Industries 

This online CAPA course will help you, your Quality Team  members, and operational personnel to understand the following cGMP requirements:

  •  

    GMP/cGMP requirements for managing CAPAS

  • Corrective and Preventive Actions (CAPAs) – when is an action a corrective action vs preventive action
  •  

    CAPA root cause investigation requirements and CAPA recordkeeping  

  • Risk assessments and root cause analysis (methods)
  •  

    Quality Management System/Pharmaceutical Quality Systems (PQS) procedures for CAPAs

This course includes CAPA case studies and CAPA warning letters/insights from various Authorities. It includes CAPA requirements/cGMP regulatory guidance examples relevant to the US FDA, the Australian TGA, the European Union (EU) EMA, the UK MHRA, and more.

CAPA Training Course Duration

The course will take approximately 2 to 3 hours to complete.

  •  

    It is a follow-up course to the GMP/cGMP training course: Management of Deviations and Non-Conformances (GMP training materials).

  • Note: While our cGMP Certificate training course materials will help you understand CAPA  compliance requirements (in a plain language, multi-media/visually-enhanced format), employees and manufacturers still need to read, understand and comply with all relevant regulations.

What you will learn in this CAPA requirements training course

This course includes examples and resources derived from industry experts including Regulatory Authorities (e.g., the Australian TGA, the US FDA, the EMA, MHRA, and others).

Examples of topics covered in this CAPA compliance (cGMP) certificate training course include:

  •  

    Regulations relating to CAPA requirements (corrective and preventive actions)

  • GMP – Deviation management procedures
  • Scenarios that may lead to a CAPA
  •  

    Root cause analysis (investigation methods)

  •  

    Product disposition 

  •  

    Personnel responsibilities for CAPA implementation

  •  

    Impact assessments

  •  

    Requirements for documenting justifications and other CAPA information

  •  

    Product quality reviews and CAPA effectiveness checks (importance of creating a cGMP/GMP compliance culture)

  •  

    Continuous improvement approaches

CAPA-training-cGMP-medicaldevices

What does the acronym CAPA mean in a GMP/GXP environment?

Definition of CAPA (GMP/cGMP)

The acronym “CAPA” in GMP/cGMP environments means ‘corrective actions and preventive actions’. CAPAs involve actions [evaluated and implemented] taken in response to a manufacturing issue. For example, CAPAs may be required due to a production error (human error, machine malfunction, etc.), a product or packaging defect, a GMP non-conformance finding or manufacturing deviation, an out-of-specification testing result and/or other quality management issue.

What manufacturing companies must comply with CAPA requirements?
  • Corrective actions = remedial actions, and preventive actions (CAPA), form part of quality risk management (QRM) responsibilities and CAPA systems are essential components of a company’s quality management system (QMS or PQS).
  • CAPA GMP requirements apply to all types of therapeutic products including medical devices, biologicals/ATMPs, and other pharmaceuticals including:

Why take this course?

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. Implementing CAPAs in GMP environments must be appropriate, justified, and fully documented and monitored during implementation.

This cGMP/GMP CAPA requirements training course — ideally completed after completing the Deviations and Non-Conformances Management course (online) — 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.

GMP industry personnel needing CAPA training

  •  

    This course is ideally suited for quality management professionals, business owners, and operational personnel working in the pharmaceutical and/or medical device sectors.

  •  

    It is suitable for individuals across a wide range of industry roles.

  • This includes individuals working in drug development/testing and clinical trials, medicine production/pharmaceutical operations, supplier qualification personnel, the certification & batch release professional (responsible person/authorised person), packaging personnel/contractors, warehousing/distribution, and logistics.
  •  

    Successful cGMP course completion earns course participants a CAPA GMP Certificate of Completion.

  • The GMP course certificate should be saved in your personnel records and should accompany the person’s CV when applying for GMP industry jobs.

cGMP regulations: CAPA recordkeeping  

Learn what’s required in GMP regulations for CAPA systems and documentation in this CAPA training course — available online!

GMP Training Course Costs  

  • Our online GMP training materials (online courses) are listed in US dollars.
  • Standard courses often cost $35 USD each, but there’s a special bulk rate when you purchase 4 or more in a bundle.
  • Not all courses are standard courses.

You can purchase a single course or just a few courses — whatever you need to enhance your onsite training program.

Do you need CAPA training for your personnel?

If you need to train large numbers of employees for complaints management, GMP Deviations and Non-Conformances Management, root cause analysis and CAPA implementation in a cGMP environment, you can contact us for a quote. Alternatively, you can 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.

All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.

Other cGMP Training/GMP education options

Why PharmOut?

PharmOut is committed to keeping pace with the global GMP regulatory changes including PIC/S, ISO standards, and other industry standards, in order to offer digestible, time and cost-effective courses helping the industry remain compliant.

Our GMP/cGMP training courses are concise yet thorough. They are available in self-paced, multi-media formats, using plain language and images to help users better learn GMP compliance requirements and industry standards. Examples include courses covering compliance guidance from the FDA CFRs, ISO 13485 and ISO 14971 standards for medical device manufacturers. 

On successful completion of your online course assessment (included with the course), course participants gain their cGMP/GMP course completion certificate. Note: PharmOut Pty Ltd also offers a range of additional industry training and GMP consulting services to suit your business or professional needs.

 

Expert Consultants for the Pharmaceutical & Medical Device Industries

Contact PharmOut for architectural, engineering, validation/equipment qualification and cleanroom expertise.

Are your SOPs for deviation management out of date?

Click here for Deviation Management examples and click here for QMS documentation examples and templates. Technical writers for SOPs and QMS system documentation are also available from our GMP pharmaceutical industry expert consultants, cleanroom engineers, validation experts, and medical device industry consultants.

 

 

An online training program to help Personnel and Regulatory Authorities understand CAPA requirements (Corrective and Preventive Actions) and relevant GMP compliance requirements.

CAPA Training

CAPAs in the Pharmaceuticals, Veterinary Medicines, and Medical Device Industries 

This online CAPA course will help you, your Quality Team  members, and operational personnel to understand the following cGMP requirements:

  •  

    GMP/cGMP requirements for managing CAPAS

  • Corrective and Preventive Actions (CAPAs) – when is an action a corrective action vs preventive action
  •  

    CAPA root cause investigation requirements and CAPA recordkeeping  

  • Risk assessments and root cause analysis (methods)
  •  

    Quality Management System/Pharmaceutical Quality Systems (PQS) procedures for CAPAs

This course includes CAPA case studies and CAPA warning letters/insights from various Authorities. It includes CAPA requirements/cGMP regulatory guidance examples relevant to the US FDA, the Australian TGA, the European Union (EU) EMA, the UK MHRA, and more.

CAPA Training Course Duration

The course will take approximately 2 to 3 hours to complete.

  •  

    It is a follow-up course to the GMP/cGMP training course: Management of Deviations and Non-Conformances (GMP training materials).

  • Note: While our cGMP Certificate training course materials will help you understand CAPA  compliance requirements (in a plain language, multi-media/visually-enhanced format), employees and manufacturers still need to read, understand and comply with all relevant regulations.

What you will learn in this CAPA requirements training course

This course includes examples and resources derived from industry experts including Regulatory Authorities (e.g., the Australian TGA, the US FDA, the EMA, MHRA, and others).

Examples of topics covered in this CAPA compliance (cGMP) certificate training course include:

  •  

    Regulations relating to CAPA requirements (corrective and preventive actions)

  • GMP – Deviation management procedures
  • Scenarios that may lead to a CAPA
  •  

    Root cause analysis (investigation methods)

  •  

    Product disposition 

  •  

    Personnel responsibilities for CAPA implementation

  •  

    Impact assessments

  •  

    Requirements for documenting justifications and other CAPA information

  •  

    Product quality reviews and CAPA effectiveness checks (importance of creating a cGMP/GMP compliance culture)

  •  

    Continuous improvement approaches

CAPA-training-cGMP-medicaldevices

What does the acronym CAPA mean in a GMP/GXP environment?

Definition of CAPA (GMP/cGMP)

The acronym “CAPA” in GMP/cGMP environments means ‘corrective actions and preventive actions’. CAPAs involve actions [evaluated and implemented] taken in response to a manufacturing issue. For example, CAPAs may be required due to a production error (human error, machine malfunction, etc.), a product or packaging defect, a GMP non-conformance finding or manufacturing deviation, an out-of-specification testing result and/or other quality management issue.

What manufacturing companies must comply with CAPA requirements?
  • Corrective actions = remedial actions, and preventive actions (CAPA), form part of quality risk management (QRM) responsibilities and CAPA systems are essential components of a company’s quality management system (QMS or PQS).
  • CAPA GMP requirements apply to all types of therapeutic products including medical devices, biologicals/ATMPs, and other pharmaceuticals including:

Why take this course?

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. Implementing CAPAs in GMP environments must be appropriate, justified, and fully documented and monitored during implementation.

This cGMP/GMP CAPA requirements training course — ideally completed after completing the Deviations and Non-Conformances Management course (online) — 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.

GMP industry personnel needing CAPA training

  •  

    This course is ideally suited for quality management professionals, business owners, and operational personnel working in the pharmaceutical and/or medical device sectors.

  •  

    It is suitable for individuals across a wide range of industry roles.

  • This includes individuals working in drug development/testing and clinical trials, medicine production/pharmaceutical operations, supplier qualification personnel, the certification & batch release professional (responsible person/authorised person), packaging personnel/contractors, warehousing/distribution, and logistics.
  •  

    Successful cGMP course completion earns course participants a CAPA GMP Certificate of Completion.

  • The GMP course certificate should be saved in your personnel records and should accompany the person’s CV when applying for GMP industry jobs.

cGMP regulations: CAPA recordkeeping  

Learn what’s required in GMP regulations for CAPA systems and documentation in this CAPA training course — available online!

GMP Training Course Costs  

  • Our online GMP training materials (online courses) are listed in US dollars.
  • Standard courses often cost $35 USD each, but there’s a special bulk rate when you purchase 4 or more in a bundle.
  • Not all courses are standard courses.

You can purchase a single course or just a few courses — whatever you need to enhance your onsite training program.

Do you need CAPA training for your personnel?

If you need to train large numbers of employees for complaints management, GMP Deviations and Non-Conformances Management, root cause analysis and CAPA implementation in a cGMP environment, you can contact us for a quote. Alternatively, you can 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.

All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.

Other cGMP Training/GMP education options

Why PharmOut?

PharmOut is committed to keeping pace with the global GMP regulatory changes including PIC/S, ISO standards, and other industry standards, in order to offer digestible, time and cost-effective courses helping the industry remain compliant.

Our GMP/cGMP training courses are concise yet thorough. They are available in self-paced, multi-media formats, using plain language and images to help users better learn GMP compliance requirements and industry standards. Examples include courses covering compliance guidance from the FDA CFRs, ISO 13485 and ISO 14971 standards for medical device manufacturers. 

On successful completion of your online course assessment (included with the course), course participants gain their cGMP/GMP course completion certificate. Note: PharmOut Pty Ltd also offers a range of additional industry training and GMP consulting services to suit your business or professional needs.

 

Expert Consultants for the Pharmaceutical & Medical Device Industries

Contact PharmOut for architectural, engineering, validation/equipment qualification and cleanroom expertise.

Are your SOPs for deviation management out of date?

Click here for Deviation Management examples and click here for QMS documentation examples and templates. Technical writers for SOPs and QMS system documentation are also available from our GMP pharmaceutical industry expert consultants, cleanroom engineers, validation experts, and medical device industry consultants.