TRAINING

The training component is a regulatory requirement. The regulation stipulates that all employees affected by GMP’s activities should receive training on GMP’s and Standard Operating Procedures (SOP’s).

 

Concerning medical devices, Health Canada requires manufacturers to use a Quality System certificate (ISO 13485) for Class II, III and IV devices as evidence of compliance to the appropriate regulatory Quality System. The Quality Management System ISO 13485 stipulates that the staff should receive training for every work that has an impact on products’ quality.

 

SYLLA CONSEILS INC. offers training based on the requests and needs of the company on the following subjects:

 

• GOOD MANUFACTURING PRACTICES (GMP’s)

• THE IMPORTANCE OF STANDARD OPERATING PROCEDURES (SOP’s), UPDATES AND FOLLOW-UPS

• QUALITY SYSTEM ISO 13485

• HACCP SYSTEM

• OTHER TRAININGS ACCORDING TO CLIENT’S NEEDS