MedicalMountains GmbH Production Process Control

target group

Specialists and managers from the areas of quality, production and work preparation, development and marketing.

content

According to 21 CFR 820 and DIN EN ISO 13485, every medical technology manufacturer must ensure that its products conform to its specifications. To this end, the regulations require production processes to be developed, applied, maintained and monitored. In addition to CAPA, production and process control has been among the TOP 2 observations found during inspections for many years - especially by the FDA. This seminar provides an overview of the required points for the area of production and process control. The requirements mentioned within the production environment are highlighted and background information and practical tips are provided in the form of examples and forms. Furthermore, the requirements that are critical from the point of view of the authorities are presented and dealt with.

topic overview

• Production and Process Control
• Control of test devices (Inspection, Measurement and Test Equipment)
• Calibration
• Process Validation
• Supplier control (purchasing controls)
• Labeling and packaging control
• Identification and Traceability
• Acceptance activities such as B. Goods receipt and in-process controls (acceptance activities)
• Handling, Storage, Distribution and Installation
• Customer Service
• Statistical Techniques

previous knowledge

Initial experience with QM systems is an advantage.

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