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WEBINAR

EDITION 

Advanced Training Course on

GMp

Guidelines

&

quality assurance        overview

Contant us to schedule an English version of the course!

 
SESSIONS
Session 1
3 hours
Session 2
3 hours
Session 3
3 hours
Session 4
3 hours
Session 5
3 hours
Description of the pharmaceutical industry
Definition and classification of the main areas
GMPs and FDA regulations: how do you work in GMP compliance environments ?
The key figures of the Quality Assurance, Quality Control, Production and Warehouse Departments
Quality System Part I
Change Control
Deviations
CAPA
OOS
Quality System Part II
Batch Record Review
Batch Release
Annual Product Review  
Quality System Part III
Process Validation  
Cleaning Validation
Quality System Part IV
Self-Inspection Management, Supplier Audit, Training Management System
Each module will use practical examples which are typical of  routine processes QA activities of each pharmaceutical company.
 
Forum space

The Advanced Training Course on 
"Quality Assurance Overview" gives you a better knowledge of the Quality Assurance Department operating in the pharmaceutical industries and provides the basic notions necessary to become a Quality Assurance Specialist.

The Quality Assurance Specialist is an important and highly specialized figure able to coordinate numerous activities and areas, remaining in compliance with current 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 in Florence (Italy).
Over the time, 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 in South Korea.
Specialized in FDA & GMP Compliance, she supervised and actively coordinated several Remediation, Mentoring & Quality Improvements projects concerning both drugs products and API.

At present, she works as Lead Auditor for pharma industries in Italy and over the world and supports the Quality Culture Team in regards to Quality Assurance post-graduate and company in-house trainings.  
information
Costs
Single module: 200 € 
5 modules package with 15% discount: 850 € 
The registration fee includes:
- Slides projected during the webinar session
- Participation in the online course
- Certificate of Attendance*
* To obtain the final Certificate of Participation it is necessary to participate in the complete course  that includes all 5 modules.
Who is the webinar for?
  • Post-graduates and in course graduates in lifescience degrees such as Pharmacy, Chemistry, Chemistry and Pharmaceutical Technologies, Industrial Chemistry, Biological Sciences or similar.
  • Functions already operating in the pharma companies with basic notions but who would like to improve their knowledge and overview.
 
FAQ
  • Course level: Intensive
  • Certificate / Qualification: Certificate of Participation (only for full course attendees)
  • Course Attendance: Session of 3 hours each (total 15 hours) according to an agree pre-established schedule.
  • Training credits / Internship: No
  • Course location: Online!
Let's schedule with us your Webinar!
 
 
Scheduled Webinar
Webinar Ottobre 2020
Oct 08, 9:00 AM – Oct 18, 1:00 PM
Le date ricadranno dal 08 al 18 Ott. 2020
Webinar Novembre 2020
Nov 03, 9:00 AM – Nov 09, 1:00 PM
Le date ricadranno dal 03 al 08 Nov. 2020
Webinar Dicembre 2020
Dec 01, 10:00 AM – Dec 14, 2:00 PM
Le date ricadranno dal 01 al 14 Dic. 2020
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 in Florence (Italy).
Over the time, 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 in South Korea.
Specialized in FDA & GMP Compliance, she supervised and actively coordinated several Remediation, Mentoring & Quality Improvements projects concerning both drugs products and API.

At present, she works as Lead Auditor for pharma industries in Italy and over the world and supports the Quality Culture Team in regards to Quality Assurance post-graduate and company in-house trainings.  
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 in Florence (Italy).
Over the time, 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 in South Korea.
Specialized in FDA & GMP Compliance, she supervised and actively coordinated several Remediation, Mentoring & Quality Improvements projects concerning both drugs products and API.

At present, she works as Lead Auditor for pharma industries in Italy and over the world and supports the Quality Culture Team in regards to Quality Assurance post-graduate and company in-house trainings.  
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 in Florence (Italy).
Over the time, 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 in South Korea.
Specialized in FDA & GMP Compliance, she supervised and actively coordinated several Remediation, Mentoring & Quality Improvements projects concerning both drugs products and API.

At present, she works as Lead Auditor for pharma industries in Italy and over the world and supports the Quality Culture Team in regards to Quality Assurance post-graduate and company in-house trainings.  
 
 

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