GMP & GDP in three days
Rescop is represented by three of our principal consultants at the ‘GMP & GDP Driedaagse 2018’. The event is held at the Golden Tulip hotel ‘het Ampt van Nijkerkfrom’ from April 10th till 12th. This is the sixth edition of the Pharmatech Training; GMP & GDP in Three Days. The workshops are given by experienced experts from the field and from different consultancy agencies.
Rescop is proud to be a part of this event. Our principal consultants Loes Kalkman, Jos Nieuweboer and Hans Lucas will be presenting the following subjects:
Thursday, April 12th
Hans Lucas – Practical guidance on the formulation of responses to Health Authority Inspection observations.
The formulation of responses to Health Authority Inspection observations is key to the outcome of an inspection. But often, the outcome of the inspection is already celebrated as the inspectors/investigators have left the premises and the focus of the organization has returned to the daily practice. The manner of wording of responses to the reported observations, often do not get the attention they should, leading to suboptimal results. In this workshop we will go into detail in the process of responding to observations from Health Authority Inspections by addressing;
- Roles and Responsibilities;
- Timing of activities both during the inspection as well as during the close-out;
- The elements of a good written response;
- Which means / sources do we have to our disposal.
Tuesday, April 10th
Jos Nieuweboer – Criticality Analysis as QRM-tool.
A criticality analysis has the purpose to understand and control all product risks and can be summarized as the critical management of a drug product and its production process.
A critical analysis is:
- The combined knowledge of the ingredients, production process and of the final drug product;
- A risk based approach to determine which attributes are critical to the quality of the drug product and to the safety of the patient;
- The outcome of the analysis summarized in a single document (the criticality analysis report).
During the lecture the steps for the execution of a criticality analysis – and the attention points – will be explained.
Tuesday, April 10th
Loes Kalkman – Determination of risks within Computerized System Validation.
The management of risks is an essential part of Computerized System Validation. This seems to be easy, but it turns out that a lot of risks are not considered which can jeopardize patient safety, product quality and quality of data. The following topics will be discussed:
- Organizational structure (QMS);
- Validation procedures (initial risk assessment with different types (technical/compliance);
- Methodology for applying risk assessment (FRA, FMEA);
- Project Management;
- 3 P’s (risks): Process risks, Product risks, Project risks;
- Experience and validation knowledge of employees involved in validation activities.