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
Target Group
Personnel within Design Control, Production, Laboratory and Quality Control in Life Science industry
Prior Knowledge/Experience
No need of prior knowledge.
Course Goal
Hands on knowledge on traceability and document requirements.
Course Material
Course material is provided, printed for courses onsite and digital for courses online. Course material will be in English, verbal presentation and discussions in Swedish.
Certificate
After successfully completing the course, which includes a proficiency test the participant will receive a certificate.
Course Leader
Anna-Karin Areskog, Senior Quality and Regulatory Consultant
Dates and location
Online
TBD
Prices
SEK 5 500:-
For member companies to Swedish Labtech
SEK 3 900:-
All prices excl. local VAT.
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
