Course duration: Allow 1.5 to 2 hours to complete this course.
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PIC/S cGMP Course on Complaints Management (Medicines, Medical Devices, Other Therapeutic Goods)
Complaints management in a GMP environment
This Complaints Management course (covering Pharmaceuticals, Medical Devices & Veterinary Medicines sectors) can help answer the following GMP compliance questions:
- What are the regulatory requirements/cGMP rules for managing complaints in GMP environments?
- Are quality defect complaints handled differently from general customer service-related complaints?
- What does your GMP Complaints Management System need to include in terms of:
- Pharmaceutical Complaint Investigations/Medical Device Complaint Investigations
- Notifications to Regulatory Authorities (TGA, FDA, EMA, MHRA, other Regulators)
- Where does your complaint management system fit into ongoing Pharmacovigilance (GMP)?
- What type of Poduct Recall training is required or expected by Regulatory Authorities (TGA, FDA, etc.)?
This course explores regulatory expectations for Complaints Handling/Complaints Management of therapeutic goods such as medicines, medical devices, veterinary medicines, and GMP-regulated products.
Topics covered in this GMP/cGMP Certificate Training course (online GMP training) include:
- Examples of regulatory guidance from PIC/S and ISO for complaints management
- Complaints Management GMP guidance from key Regulatory Authorities, such as the FDA, TGA, MHRA, EU/EMA
- Expectations of Regulatory Authority officials when inspecting your Complaints Management system, complaints records/handling procedures, and Pharmaceutical Quality Systems (PQS/QMS) during a GMP audit.
This GMP course on Complaints Management is suitable for a worldwide audience.
Who should take this course for Complaints Management?
- 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
This course is suggested as a pre-requisite before completing the Recalls of Therapeutic Products/Pharmaceuticals & Medical Devices cGMP training course.
Relevant GMP Training Courses
GMP (online training) courses and GMP compliance training relevant to this GMP education topic (Complaints Management) include:
- GMP training for Managing Deviations and Non-Conformances
- GMP training for implementing CAPAs
- GMP training for Managing Recalls of Medicines, Medical Devices, and other Therapeutic Goods
- Managing Complaints (GMP Guidelines) – this online training GMP compliance course
- GMP training covering Pharmacovigilance Guidelines
Complaints Management – GMP Education
In this course, you’ll learn regulatory requirements in GMP environments for the following items:
- Documents – requirements for adequate documentation of complainants and products/batches associated with the complaint
- Assessments – 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 reviews of complaint reports (and other product defect reports)
This course, and the others listed above, 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.) in the pharmaceutical/medical devices/veterinary medicines sectors.
Learn what’s required for GMP compliance for complaints management and resolution — available online!
Experts in GMP compliance education
Our online cGMP training materials provide learners with PIC/S cGMP guidance including international regulations and standards for managing quality-related complaints (product defects/other quality issues).
- This is one of our many GMP education resources
- It is available in an eLearning format accessed via the internet (24/7).
- It is a follow-up course to the cGMP deviations management course and CAPA course for GMP personnel and Managers.
- It is a suitable pre-requisite for the Recalls of Therapeutic Goods course.
- It includes examples from the EMA, FDA, MHRA, and TGA.
Need onsite training?
- Click here for a list of face-to-face courses delivered via Zoom
- Onsite or public training of larger groups of personnel may also be available
With online GMP training options, you can mix and match cGMP education courses in a training bundle package or 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 (50 or more) 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 Complaints Management is ideally suited for:
- Anyone working in the pharmaceutical or medical device industry
- Anyone with a job role related to:
- Quality management
- 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.
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 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.
Allow 1.5 to 2 hours to complete this GMP 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.