Charisma

#	Content
1	• Introduction to Site Masterfile and its purpose.
2	• Scope of manufacturing activities.
3	• Quality management systems and batch release procedures.
4	• Management of suppliers and contractors.
5	• Quality risk management and product quality reviews.
6	• Personnel organization and staffing.
7	• Premises, equipment, HVAC and utilities.
8	• Documentation systems and data archiving.
9	• Production processes and material management.
10	• Quality control activities.
11	• Distribution, complaint handling, product defects, and recall procedures.
12	• Self-inspection systems.
13	• Preparation of annexes and supporting documents.

#	Outcomes
	• Understand the structure and content requirements of a site masterfile.
	• Be able to describe quality management policies, production and quality control activities.
	Apply the guideline to compile relevant annexes like manufacturing authorizations, GMP certificates, and organizational charts.
	Comprehend the responsibilities related to supplier management, product release, documentation, and complaint handling.

#	Participants
1	� • Pharmaceutical manufacturers preparing or updating the Site Masterfile.
2	� • Quality assurance personnel.
3	� • Regulatory affairs professionals.
4	� • Senior management involved in quality management systems.