What does a GMP validation entail, why do we have to do this and when. In this training you will receive a complete overview of information.

In order to be able to carry out a project and/or qualification, the wishes and requirements must be determined in advance. This is included in the User Requirements Specification (URS) and the test protocols are compiled on the basis of this. This part is the most important step in the entire validation process and is often underexposed in practice.

In short, a risk analysis is an overview of all possible risks that can influence the project result, indicating for each risk what the consequences would be if the risk were to occur, which measures can be taken to control and who can best take these measures.
A risk analysis clearly and unambiguously describes the greatest risks, negative or positive, for a project.

The IQ qualification is the documented proof that the installations and equipment have been delivered and installed in accordance with the requirements and legal safety regulations laid down in the design qualification. The Operation Qualification OQ is a testing process that assesses the correct operation of an installation or device. During the Operation Qualification OQ, all points specified in the test plan are processed and documented in writing to ensure that the system functions in accordance with the specifications.

Performance qualification (PQ) of equipment is an important part of the validation of the entire production process over a certain period of time and for a certain product. Its purpose is to verify and document that the devices and systems operate reproducibly within the full specified operating range and limits. The devices and systems are not inspected separately, but always as part of the entire or partial process. While PQ usually includes OQ testing under process conditions, a detailed test plan based on a comprehensive process description should be prepared before at least starting the validation process.

Validation is checking a value or a method for validity or correctness. In fact, verification or qualification demonstrates with a high degree of certainty that a device, system, mathematical model or instrument is capable of producing the intended results against a number of predetermined requirements. The validation report describes the set-up and implementation of checks and measurements for the purpose of validating the equipment specified in the order description, stating any deviations found.

A Cleanroom is designed and realized with the greatest care. Before the Cleanroom is put into use, it must be demonstrated that the Cleanroom meets the requirements. By having “the correct” measurements carried out, you will receive written proof that the Cleanroom is suitable for the intended purpose. In this training we go through the entire process together with you.

Where work is done, errors and deviations also arise. But it is important that we prevent repetition or - even better - avoid deviating or making mistakes. A Corrective and Preventive Action (CAPA) system ensures that (potential) quality problems are approached and analyzed in a structured manner, and that the correct corrective and preventive measures are taken. In this training we go through the process, identify and record the deviation, get acquainted with a Root Cause Analysis (RCA) and draw up a CAPA plan

Failure Mode and Effect Analysis (FMEA) is an analysis method to identify the various possible risks in a process. The methodology is used to determine the probability of failure and the associated risks in development processes of services, products or production methods. The goal of the FMEA is to define actions that reduce the probability of failure. It provides a complete picture of the quantifiability of risks. This makes it possible to rank the urgency of the risks.

A Standard Operating Procedure (SOP) is a document in which the instructions for a certain work process are described in detail. This is especially interesting for the training of new employees, or in industries where there are very strict regulations. SOPs are drawn up for specific actions on the work floor, and are therefore very closely related to the optimization of business processes.

Processing and/or storage of temperature (and moisture) sensitive products sets requirements for the minimum and maximum temperature (and relative humidity) to which their products may be exposed during a period. During storage, the conditioned storage areas must guarantee the minimum and maximum temperature (and relative humidity). For example, GDP standards apply in the pharmaceutical industry and HACCP guidelines apply in the food industry. To be able to demonstrate that the conditioned rooms fall within the set limits (eg +15 ÷ +25°C), a permanent temperature monitoring system can be used, which has checking and alarming functions. In this training we will discuss sensor placement and qualification performance

When calibrating (measuring) devices or production machinery, the deviation (bias) of the device is determined. This can be done by comparing with a reference or with a calculated model. The deviations are recorded in a so-called correction table. With digital processing of measured values, the correction values can be settled with the measured values so that an accurate result is obtained. If the measuring instrument is calibrated, i.e. the measurement deviation is corrected, this is referred to as adjustment. Based on the calibration, it can be determined whether the measuring device still meets its specifications. In this training we will practically draw up and execute the protocol of a calibration.

Issues such as Life Cycle Model (V-model), Data Integrity, Security, Risk-based approach to GxP compliant computerized systems, qualification of IT infrastructure, reliability of communication protocols and standards from the regulatory authorities make it a maze to manage it . Do we follow CSV, the existing guideline of the GAMP5© or do we follow CSA, those new guidelines from the FDA (2020). In this training we provide insight into the possibilities, necessity and approach with the advantages and disadvantages.