Qualification and process validation in the medical device industry – Module 1: Basics
Description
Qualification and process validation are essential, indispensable steps in ensuring the safety and functionality of medical devices. Due to the complexity of many medical devices, inspections and tests alone are not sufficient to guarantee their quality. Process validation includes the creation of documented proof that a process consistently and reliably generates a result or product that meets specified requirements.
Correct qualification and validation must be performed in line with defined processes. These, in turn, should be efficient and practical. This is the only way to ensure that the teams responsible can accomplish their tasks expediently and technically correctly. Finally, the acquired validation results must pass the audits performed by supervisory bodies such as authorities and certifiers.
The seminar has a modular structure: Module 1 covers the basics; it presents the most important methods and processes for equipment qualification and process validation. Optionally, Module 2 can be booked to expand on this topic; in a workshop, a team will create a qualification and process validation concept. In this process, a real-life question relevant for the company can be chosen. For instance, the workshop can deal with a production process for which qualification/validation is currently planned. The team can apply the knowledge gained in Module 1 under direct supervision and instruction.
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Goals
This seminar explains the fundamental knowledge required for practical equipment qualification and manufacturing process validation. In particular, it details the practical procedure for determining which processes or process steps require validation. To do so, risk management is used as the basis for effective process validation. Additionally, it explains the required content of qualification and validation plans and reports. Building on this topic, the requirements stemming from laws and standards, as well as current applicable guidelines, are explained.
Seminar content
- Regulatory and standard-based methods of process qualification and validation in medical technology, taking into account the requirements of the EU Regulation on Medical Devices and EN ISO 13485
- Terms (e.g. DQ, IQ, OQ and PQ) and international guidelines on equipment qualification and process validation (e.g. IMDRF/GHTF documents)
- Effectively performing process risk analyses, e.g. for process FMEAs
- Establishing qualification and validation programmes
- The process qualification/validation sequence (procedure, responsibilities)
- Planning validation tasks (validation plan, sampling plans)
- Performing validation and documentation, required content for validation reports
- Monitoring applicability, validation master plan; integration into change management
Target group / seminar duration and certificate
The seminar is suitable for employees who plan, implement and document the qualification of equipment and validation of manufacturing processes. It is also suitable for employees involved in approving the processes, such as staff who are responsible for regulatory aims, auditors, and employees in quality management or quality assurance.
The content is presented over the course of a one-day seminar. There is also the option to book Module 2 (also presented over the course of a one-day seminar) to expand on the topic. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.
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