Thinking Outside of the GMP (Good Manufacturing Practice) Box Training Course: Strengthen Risk Management, Improve Training & Documentation, and Enhance Error Prevention (Feb 3rd - Feb 4th, 2026)

Dublin, Nov. 03, 2025 (GLOBE NEWSWIRE) -- The "Thinking Outside of the GMP (Good Manufacturing Practice) Box Training Course (Feb 3rd - Feb 4th, 2026)" training has been added to ResearchAndMarkets.com's offering.

In this GMP training course, the topics will be examined with a very different perspective, enabling you to refresh your existing knowledge and gain new expertise on the subject. After the sessions, your GMP knowledge will be enhanced with scenario studies and bonus complementary documents which willbe given in addition to the training programme and will aid your application of the new learnt techniques to the work place.

When you look at the bigger picture, it is possible to see that Good Manufacturing Practice (GMP), which we have difficulty in implementing from time to time, can actually be evaluated from different perspectives which can provide insight that gains even more value for your GMP processes and application This training course has been specially prepared to serve exactly this purpose.

In the rush to fully meet technological developments in the pharmaceutical industry, together with the expectations of the health authorities; updated and evolving guidelines; and the needs of the end-user patient, the emphasis on complying with the GMP regulations and guidelines is becoming increasingly important.

Benefits of attending

Gain an insight into top management's approach to risksLearn the training and documentation system, including planning GMP trainings and process mapping tipsUnderstand the personnel selection criteria in accordance with GMPExplore GMP compliant lateral-thinking techniques, behaviour change models in GMP and the mechanisms to prevent errors in sampling and validationEnsure cost reduction tactics in validationsAdapt lessons learnt from other sectors to GMP

Certifications:

CPD: 12 hours for your recordsCertificate of completion

Who Should Attend:

Personnel who are in a wide range of GMP-related jobs will benefit from this course, including those in:

Quality AssuranceQuality ControlGMP ComplianceValidationEngineeringOperationManufacturingSupply ChainLogisticsITPurchasing

Key Topics Covered:

Day 1

Introduction to GMP regulations

What is GMP?International guidelines and directives for GMP

Management responsibility

Who are 'Top Management'? Can we reach them?What are the main responsibilities of 'Top Management'?How does 'Top Management' approach and manage risks?Do they ask smart questions on the shop floor?

Lessons learnt from other industries

GMP excellence by designAviation and Automotive industries best practicesThe 'learning by doing' approach in a regulated environment

Learning organisation and quality culture

What is 'knowledge management'?Do we learn effectively what's taught?Is it different than that of quality risk management?Quality culture in Pharma and Biotech industriesWhich one is the best? Company culture or quality culture?

Personnel and training expectations in GMP

How to simplify trainings without compromising GMP rulesHow to select and qualify personnelAligning job descriptions with cGMPHow to deal with passengers in a QC laboratoryNew employee orientation program structureProven tactics of keeping the GMP training recordsWhat are the ten training errors?

Documentation pitfalls

How to simplify documentation without compromising GMP rulesReal dangers behind data integrity applicationsHow to handle data for GMP expectationsHow to reduce or eliminate documentation errorsHow do you ensure data integrity during validation?

Group exercise: let's improve our SOPs in microbiology laboratory

Deviation management and CAPAs

How to simply handle deviations by asking lateral questionsWho is responsible for the deviation or OOS?Sophisticated PAs approachesWhere's CA gone?Why is it so exhaustive to find the true root cause?

GMP behaviour models

How to change old GMP behavioursWhy multitasking is lurking somewhere in GMP complianceFour magic words for GMP ComplianceEliminating the non-value-added activities form GMP

Day 2

A new validation approach

How to handle deviations in cleaning and process validationIs it possible to reduce the costs in validation activities?How to prevent sampling errors in validationHow to simplify computerised system documentation? (computer software assurance and GAMP5 - second edition)Successful QC integration with GMP compliance

Knowledge-based change control

What is 'knowledge-based change control'?Change control vs. change managementHow to adapt QRM to changesHow to avoid pitfalls in CCHow frequently to monitor the effectiveness of changesFDA 483s for change control

Before and after shutdown

Things to do before and after facility shutdownDo we have to repeat aseptic process simulation?What are the main responsibilities of the engineering department during the shutdown period?How to switch from preventive maintenance to predictive maintenanceHow robust are our critical utilities (HVAC, water, steam, gas) according to current GMP guidelines?

Complaints and recalls

What is risk-based recall management?Who manages complaints in your company?

Group exercise: audit shortcuts

Technology transfer best practices

How to manage aseptic product technology transfer?What are the main pillars of GMP-compliant test method transfer?How to prevent drug shortages without compromising GMP expectations?

Outsourcing

How to find the most appropriate quality agreement templateEffective tactics to manage quality when outsourcingWhat lessons to learn from Heparin and other crises

Do you know your GMP compliance score?

Is it possible to achieve 100% GMP compliance?How to implement a gap analysis to detect quality problemsDo you know how to measure your GMP performance?How elegant is your GMP system?How to spot weakness in GMP compliance?

For more information about this training visit https://www.researchandmarkets.com/r/myzzwx

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