Deviations and Non-Conformances

Description

GMP Education (online): GMP requirements for management of Deviations and Non-Conformances.

Deviations and Non-Conformances (GMP Rules)

Deviations and Non-Conformances must be managed according to GMP regulations.

GMP Regulations/documentation requirements for managing deviations and other non-conformances

GMP requirements for managing deviations or non-conformances include, but are not limited to:

• Documenting the deviation or other non-conformance
• Following good recordkeeping practice and ensuring data integrity of deviations, investigation records and CAPAs
• Ensuring deviation documentation is included in batch records to ensure full batch traceability
• Thoroughly investigating deviations/non-conformance incidents to determine:
  • Root Cause
  • Whether a CAPA needs to be initiated
• Conducting Product Quality Reviews (PQRs) per the PQS schedule, including a review of the effectiveness of Deviation Management and CAPA systems

GMP Course Agenda

This training presentation covering the Management of Deviations & Non-conformances, in GMP sectors, includes the following topics:

• 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
  • Refer to the GMP eLearning course for CAPA requirements
  • Refer also to live-streamed CAPA courses 

• environments.

Who should take this Deviations and Non-Conformances online training course?

The course should be completed by any professional in a GMP environment. This includes operational personnel, Quality Associates, Quality Managers, Team Leaders, Business Owners, Responsible Persons, and other responsible personnel.

 

This training course to comply with GMP rules for managing deviations & non-compliances 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

Relevant GMP/cGMP Training Courses (GMP Certificate Courses, all online) include:

• GMP training for Managing Deviations and Non-Conformances (this course)
• GMP training for implementing CAPAs 
• Managing Complaints (GMP Guidelines)
• GMP training covering Pharmacovigilance Guidelines
• Pharmaceutical Recalls Training/Medical Device Recalls Training

Why complete this cGMP/GMP training course for regulatory compliance?

• This GMP industry course on deviation & non-conformance management will help you understand what’s required of all GMP personnel when a deviation/non-conformance is discovered.
• No matter how minor the deviation is considered to be, all deviations must be documented properly, and risk-assessed.
• Not managing deviations/non-conformances according to regulatory requirements can result in product safety risks, audit findings, and potential pharmaceutical recalls.
• The course is available in an immediate/24-7 learning format over the internet (one user per licence).

PharmOut’s GMP industry training experts have designed a course to help personnel learn the regulatory requirements for managing Deviations & other Non-Conformance events.

Online GMP training: Managing Deviations & Non-Compliances

• The course provides learners with guidance on Deviations Management/Non-Conformance management in GMP sectors
• It includes guidance on recordkeeping requirements, deviation investigations, and when to initiate a CAPA
• It includes guidance from PIC/S and regulatory authorities such as the FDA and TGA relating to the management of deviations and non-conformances (including unplanned deviations).

This is one of our many GMP education topics eLearning courses available 24/7.

 

Relevant GMP education topics

• This course can be taken prior to completing the certificate course on GMP CAPA requirements (online GMP training)
• You can also click here for a list of face-to-face courses delivered via Zoom (or in person subject to availability)
• You can purchase a single course (one learner/one certificate/per course) or a discounted bundle of 4 or more courses.
• You can mix and match certificate GMP eLearning courses with a training bundle package or contact us for custom solutions for over 50 to 100 or more employees.

GMP Training Materials: GMP eLearning Solutions

Do you need to train your GMP personnel to report, investigate, and manage Deviations and Non-Conformances?

• If you need to train large groups of employees on regulatory compliance, including 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. To view the bundle options, click on the bundles tab (towards the top of this page).

Professionals & Job Roles in Deviations Management

This certificate GMP training course for management of deviations and non-conformances is ideally suited for:

• Professionals working in the pharmaceutical or medical device industry
• GMP personnel with a job role related to:
  • incoming materials testing
  • GMP manufacturing including biologicals or sterile medicines
  • packaging/labelling
  • complaints handling
• Quality management professionals
• Operations Managers
• Production line personnel
• Manufacturing Licence holders (MAH/medicine manufacturers)
• Administration personnel
• Responsible Persons/Authorised Persons (Batch release & quality management personnel)

Online GMP Training – Pharmaceutical Industry courses

The Deviations and Non-Conformances Management (cGMP training) course is based on:

• PIC/S guidance publications for deviations/non-conformance management
• Insights from pharmaceutical manufacturing industry experts (GMP consultants).
• Guidance examples from Regulatory Authorities including FDA guidelines for deviations management and/or non-conformances, recordkeeping and procedures for product impact assessments/criticality assessments/product disposition).

Gain a cGMP Certificate for this course topic

• 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.

How to complete this training (online GMP training)

• Add this Deviations and Non-conformances (GMP regulations) training course and other relevant GMP education course selections to your basket (scroll up)
• Consider training bundles (GMP training packages) if you are ordering several courses to save on fees (add the bundle to your cart and choose from our standard GMP courses)
• Complete your 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 (and add to your “Safe Senders”/contacts list) the following domains: “@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 (learner) 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

Allow 1.5 to 2 hours to complete this GMP regulations/Deviations and Non-Conformances eLearning training course including the online Final Assessment.

Other Options

Return to the online GMP training store to explore over 65 GMP eLearning options.

• Pharmaceutical/biological manufacturing industry induction training modules.
• GMP training bundles and discounted options (mix and match.
• Facilitated GMP courses (onsite or public courses including computer system validation)

PS: 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.
• Other GMP facility and manufacturing services by expert GMP consultants.