Content
According to 21 CFR 820 and DIN EN ISO 13485, every medical technology manufacturer must ensure that their products conform to their specifications. For this purpose, the regulations require production processes to be developed, applied, maintained and monitored. In addition to CAPA, production and process control has been one of 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 examined and background information and practical tips are provided in the form of examples and forms. Furthermore, the requirements that are critical from the authorities' perspective are presented.
Topic overview
- Production and Process Control
- Control of test equipment (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 Methods
target group
Specialist staff and managers from the areas of quality, production and work preparation, development and marketing.
Prior knowledge
Initial experience with QM systems is an advantage.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
