Advanced Training Course on

GMP GUIDELINES  &

quality 

  assurance         overview

Upcoming events:

WEBINAR EDITION!

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!

 
AGENDA
How pharma industries work
​Definition and main area classification
Organization Charts
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

Documentation handling

​Batch Record Review and Batch Release
Annual Product Review  
First Day
09:00 - 17:00
Second Day
09:00 - 17:00
Quality System
Change Control and Deviation Management,
CAPAs and OOS
Self-Inspection Management and Suplier Audit,
Process and Cleaning Validation,
Training Management
Forums 

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.

 

trainer
Karyn Santoro
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.  
information
Cost 
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
  • Internship: 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.
 
 
SUBSCRIBE ME
Webinar Ottobre 2020
Thu, Oct 08
Le date ricadranno dal 08 al 18 Ott. 2020
Oct 08, 9:00 AM – Oct 18, 1:00 PM
Le date ricadranno dal 08 al 18 Ott. 2020
L’obiettivo del corso webinar è quello di formarti ad un inserimento rapido nel Dipartimento Quality Assurance di aziende farmaceutiche, analizzando i concetti fondamentali riportati dalle Normative GMP e le attività complesse che vengono gestite dal Quality Assurance Specialist.
Webinar Novembre 2020
Tue, Nov 03
Le date ricadranno dal 03 al 08 Nov. 2020
Nov 03, 9:00 AM – Nov 09, 1:00 PM
Le date ricadranno dal 03 al 08 Nov. 2020
L’obiettivo del corso webinar è quello di formarti ad un inserimento rapido nel Dipartimento Quality Assurance di aziende farmaceutiche, analizzando i concetti fondamentali riportati dalle Normative GMP e le attività complesse che vengono gestite dal Quality Assurance Specialist.
Webinar Dicembre 2020
Tue, Dec 01
Le date ricadranno dal 01 al 14 Dic. 2020
Dec 01, 10:00 AM – Dec 14, 2:00 PM
Le date ricadranno dal 01 al 14 Dic. 2020
L’obiettivo del corso webinar è quello di formarti ad un inserimento rapido nel Dipartimento Quality Assurance di aziende farmaceutiche, analizzando i concetti fondamentali riportati dalle Normative GMP e le attività complesse che vengono gestite dal Quality Assurance Specialist.
 
 

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Quality Culture agisce in rispetto dei dati personali ai sensi dell'art.13 del Decreto Legislativo 196/2003