GMP – Good Manufacturing Practice

This course will show documentation requirements under GMP regulations for the Medical Device and In Vitro Diagnostic industry. Documentation in this type of industry is expected to have a high level of traceability in the complete manufacturing process (for methods, facilities, and controls used in manufacturing, processing, and packing of a product). Purpose of following GMP is to, with a risk-based approach, minimize or eliminate instances of contamination, mix-ups, and errors. The traceability simplifies evaluations and improvements of the product and process, when needed.

Topics

• Traceability requirements

• Documentation practice

Prior Knowledge/Experience

No need of prior knowledge.

Course Goal

Hands on knowledge on traceability and document requirements.

Course Leader

Anna-Karin Areskog, Senior Quality and Regulatory Consultant

The course is arranged by Swedish Labtech in co-operation with QAdvis.