Complaints Management

USD $35.00

Course duration: Allow 1.5 to 2 hours to complete this course.

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Description

PIC/S cGMP Course on Complaints Management

Complaints management systems in GMP environments

What are the regulatory requirements for managing complaints in cGMP environments? Are quality defect complaints handled differently from general customer service-related complaints? And what does your cGMP Complaints Management System need to include in terms of investigations and notifications to regulatory authorities, such as when a product recall is required?

This course explores regulatory expectations for complaints handling/complaints management.

Course content includes:

  • Examples of regulatory guidance for complaints management from PIC/S and ISO publications
  • Guidance from publications from key Regulatory Authorities such as the FDA, TGA, MHRA, EU/EMA
  • Regulatory Authority expectations when inspecting your Complaints Management records and Pharmaceutical Quality Systems/Quality Management Systems (PQS/QMS) during a GMP compliance audit.
This GMP course on Complaints Management is suitable for a worldwide audience.

It is also suitable for a variety of personnel roles from researchers including but not limited to:

  • Quality Department professionals
  • Pharmacovigilance teams
  • Third-party contractors responsible for post-marketing monitoring and complaints handling
  • Medical device manufacturing personnel
  • Other personnel working in a GMP/cGMP environment
    • Product managers and laboratory testing personnel
    • Operations Managers/Department Managers
    • Production line-workers
    • Customer service/sales representatives
    • Administrative officers
    • Distribution/logistics personnel

It is recommended as a pre-requisite for the Recalls of Therapeutic Products/Goods course.


Complaints Management – GMP Course topics

Regulations for managing complaints in cGMP environments, covered in this training course, include the following:
  • Adequate documentation of complainants and products/batches associated with the complaint
  • Impact assessments/risk assessments including validity, severity, and risks
  • Escalation of quality-related complaints based on initial assessments and risks
  • Investigations of complaints and documented justification for actions taken
  • Communications: notification of Regulators and other impacted parties (if required)
  • Management review/s of complaint reports and other product defect reports

Complaints Management

This Complaints Management course — when completed along with the Deviations and Non-Conformances management course and the CAPA course — will help you understand what’s required of all GMP personnel, Department Managers, Quality Managers, and Business Owners when managing complaints and other product quality issues (defects, out-of-specification test results, non-conformance issues, etc.)


Learn what’s required for GMP compliance for complaints management and resolution — available online!


GMP industry training experts

CAPA-course-cGMP-PICS-Capa-training

The course provides learners with PIC/S cGMP guidance including international regulations and standards for managing quality-related complaints (product defects/other quality issues).

With online training for CAPA implementation and GMP requirements, you can mix and match GMP education courses with a training bundle package or alternatively 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?

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 Complaints Management is ideally suited for:

  • Anyone working in the pharmaceutical or medical device industry
  • Anyone with a job role related to:
    • Quality management
    • Pharmacovigilance
    • Customer service or Accounts Management
    • Distribution (sales)
    • cGMP manufacturing, including medicines, biologicals/blood products/human tissues, vaccines, medical devices, and veterinary medicines
    • Complaints handling
  • Quality management professionals
  • Production line personnel (as appropriate)
  • Manufacturing Licence holders (MAH/medicine manufacturers)
  • Administration personnel

Consider our intensive eLearning course in Therapeutic Goods Recall requirements (PIC/S Recall Guidance with examples from the FDA, TGA, EMA and MHRA.


About this Pharmaceutical Industry training course

  • The CAPA GMP regulations training course is based on PIC/S publications and insights from pharmaceutical manufacturing industry experts (GMP consultants).
  • It includes examples of PICS/S guidelines for deviation 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 authorities.
  • 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 for Complaints Management in GMP environments include:

  • Complaint system requirements/complaint procedures
  • PIC/s GMP regulations and regional regulations/guidelines for complaints management (with examples from the TGA, FDA, MHRA, EU/EMA, ISO, etc.)
  • Personnel responsibilities and roles when receiving, documenting, investigating, and responding to a complaint
  • Initial complaint assessments and investigations
  • Quality complaints (product defect complaints or reports) versus non-quality complaints
  • Escalation and potential recalls

This course, along with the Deviations & Non-Conformances and CAPA training courses, is a suitable precursor for the Recalls of Therapeutic Products course.

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 Complaints Management
  • 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, pharmacovigilance, customer service, Quality Management, operations and distribution departments of medical devices, pharmaceutical products, therapeutic goods, 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 GMP regulations compliance training course is available online, one user per licence
  • Course completion provides learners with a foundational understanding of Complaints Management requirements including recordkeeping responsibilities

Who should take this online Complaints Management (cGMP) 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 CAPA-course-PICS-cGMP-corrective-preventive-acxtions-course 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 complaints management systems, including documentation, investigations, escalation and notification 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.

complaints management regulations PIC/S FDA CFRs ISO MHRA EMA


Allow 1.5 to 2 hours to complete this GMP eLearning training course including the online Final Assessment.

Other recommended courses include:

Pharmaceutical Product Recalls

CAPA training presentation (live-streamed)

Deviations and Non-Conformances (Management) in cGMP environments

Complaints Handling and Recalls (available now)

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