GMP requirements for management of Deviations and Non-Conformances
Deviations and Non-Conformances (GMP regulations and documentation requirements)
- Deviations and Non-Conformances must be managed according to GMP regulations.
- GMP requirements include (but are not limited to) documenting the deviation, ensuring deviation documentation is included in batch records to ensure full batch traceability, and thoroughly investigating deviations/non-conformance incidents for ‘root cause’ to determine if a CAPA needs to be initiated.
Product Quality Reviews (PQRs) must also include a review of the effectiveness of the deviation management systems and CAPA systems.
- This newly-released Deviation Management Training Course (Deviations and Non-Conformances) will help you understand what’s required of all GMP personnel when a deviation is discovered.
- No matter how minor the deviation is considered to be, these must be documented and properly risk-assessed, or you’ll be incurring product quality safety risks (patient harms) and potential future recalls.
GMP industry training experts
The course provides learners with guidance on Deviations Management regulations (e.g. PIC/S guidelines, FDA guidelines and common audit findings) for the management of deviations/unplanned deviations.
- This is one of our many GMP education topics eLearning courses available 24/7.
- It is a precursor to the completion of a CAPA training course (click here for a list of face-to-face courses delivered via Zoom (or in person if feasible).
- You can mix and match courses with a training bundle package OR purchase a single course (one learner/one certificate/per course).
Do you need to train your personnel to follow SOPs for Deviations and Non-Conformances?
- If you need to train large numbers of employees on 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 management of deviations and non-conformances is ideally suited for:
- Anyone working in the pharmaceutical or medical device industry
- Anyone with a job role related to:
- incoming materials testing
- GMP manufacturing including biologicals or sterile medicines
- complaints handling
- Quality management professionals
- Production line personnel
- Manufacturing Licence holders (MAH/medicine manufacturers)
- Administration personnel
About this Pharmaceutical Industry training course
- The Deviations and Non-Conformances 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 and FDA guidelines for deviations management and/or non-conformances (GMP recordkeeping and deviation management processes and procedures, such as product impact assessments/criticality).
- 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 in the training presentation / GMP eLearning course for management of Deviations and Non-conformances include:
- GMP regulations for deviations management (unplanned deviations vs planned deviations)
- Deviation management personnel responsibilities
- Deviation management procedures and SOPs
- Impact assessments
- Quality risk management (QRM)
- Deviations and product risk criticality (classifications)
- Remedial actions and corrections (corrective actions)
- Deviation investigation requirements including root cause analysis (RCA) tools
- Requirements for documenting and responding to deviations and non-conformance incidents
- Product disposition
- Product Quality Reviews and deviation logs
- When to initiate a CAPA (click here to register your interest in attending a live-streamed CAPA course GMP presentation)
- Note: The CAPA eLearning course will be available online by early 2022.
Snapshot of this certificate GMP online training course:
- This course focuses on GMP requirements for managing manufacturing deviations including yield deviations
- Includes handling of non-conformances and other product quality incidents/out-of-specification (OOS) testing results
- Discusses various types of deviations including deviation criticality (criticality categorisations of product impact/product risks)
- The course is ideally suited for anyone working in the pharmaceutical industry including ATMPS, biologicals, sterile medicines, etc.
How to complete this course.
Add the course to your basket and complete the purchase.
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)
- Deviations and Non-conformances (GMP regulations) training course is available online, one user per licence.
- Course completion provides learners with a foundational understanding of deviation management procedures, processes, root cause investigation requirements, batch recordkeeping requirements, and various personnel responsibilities in GMP environments.
Who should take this Deviations and Non-Conformances online training 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:
- Authorised Person(s) / Qualified Persons
- Operations Managers
- Production line workers
- Pharmaceutical Quality Department members (Quality Managers)
- Area Managers/Department leaders
- Laboratory/testing laboratory personnel (chemists, scientists, researchers, etc)
- 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 their responsibilities for managing deviations and non-conformance incidents or events.
- This course will assist personnel of all levels to recognise GMP regulatory expectations in relation to Deviations and Non-Conformances.
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.