Advanced Training Course on
GMP GUIDELINES &
From 01 to 07 June 2020* - From 01 to 06 July 2020* (Italian language)
*Dates and time to be agreed with each partecipant.
Contant us to schedule an English version of the course!
How pharma industries work
Definition and main area classification
GMPs and FDA regulations: how to work in a GMP compliance environment?
The Quality Team
Key functions operating on Quality Assurance Dept., Quality Control Dept., Production and Warehouse
Batch Record Review and Batch Release
Annual Product Review
09:00 - 17:00
09:00 - 17:00
Change Control and Deviation Management,
CAPAs and OOS
Self-Inspection Management and Suplier Audit,
Process and Cleaning Validation,
The Advanced Training Course on
"GMP Guidelines & Quality Assurance Overview" gives you a better understanding of the Quality Assurance Department operating in the pharmaceutical industries.
The aim is to provides the basic notions necessary to become a Quality Assurance Specialist that is an important and highly specialized figure able to coordinate numerous activities and areas, remaining in compliance with current GMP regulations.
Senior Quality Assurance Consultant
After the MD in Chemistry and Pharmaceutical Technology issued by the University of Bologna, she started working in the Quality Assurance Department of Menarini Manufacturing company situated in Florence, Italy.
Over the years, she became a QA consultant for various big pharma industries such as Pfizer, Patheon, Merck and TEVA and also as Lead Inspector for pharmaceutical industries located in South Korea.
Specialized in FDA & GMP Compliance, she supervised and actively coordinated several projects of Remediation, Mentoring & Quality Improvements concerning drugs products and API.
Now she works as Lead Auditor for pharma industries around the world and she supports the Quality Culture Team in regards to Quality Assurance post-graduate and company in-house trainings.
Full price: 850 €
Discounted price: 680 € for registration within 60 days.
The registration fee includes:
- Teaching materials
- Participation in the course
- Certificate of Attendance
- Coffee Break
Who is it for?
Postgraduated and graduates in Lifescience studies such as Pharmacy, Chemistry, Chemistry and Pharmaceutical Technologies, Industrial Chemistry, Biological Sciences or similar.
Functions already operating in pharma industries with basic notions but who wish to improve their knowledge and overview.
What they often ask us
Course level: Intensive
Certificate / Qualification: Certificate of Attendance
Course attendance: Weekend (total 16 hours)
Training credits: No
Course location: The exact location will be communicated by e-mail to the individual enrolled participants. Central areas will be chosen and easily accessible by public transport.
Is it possible to book a course? Yes. New venues and dates can be agreed for groups consisting of a minimum number of 10 participants.